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IEC 60601-1:2005+AMD1:2012 CSV

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

09-05-2020

Published date

08-20-2012

IEC 60601-1:2005+A1:2012 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This document includes the contents of the corrigenda 1 (2006), 2 (2007) and 3 (2022), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009), 3 (2013) and interpretation sheet to amendment 1 (2021).

IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition.

Committee
TC 62/SC 62A
DevelopmentNote
Stability Date: 2019. (10/2012) Supersedes IEC 60601-2-32. (11/2012)
DocumentType
Standard
ISBN
978-2-8322-0331-6
Pages
1660
ProductNote
CSV VERSION IS NOW AVAILABLE
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 10524-4:2008-09 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
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DIN EN 60601-2-30 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
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NF ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
BS 5724-2-45(2001) : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
BS EN 61331-1:2014 Protective devices against diagnostic medical X-radiation Determination of attenuation properties of materials
BS EN 60601-2-51:2003 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
UNE-EN 80001-1:2012 Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities
AAMI IEC TIR 60878 : 2003 GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
CEI EN 60601-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
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CSA Z8835.3 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
CSA CEI/IEC 1288.2 : 1998 CARDIAC DEFIBRILLATORS - CARDIAC DEFIBRILLATORS-MONITORS - PART 2: MAINTENANCE
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PD IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice
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IEEE 1708-2014 IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices
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09/30193293 DC : DRAFT MAR 2009 BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
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I.S. EN 80001-1:2011 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
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NF EN 60601-1-8 : 2007 AMD 11 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
PD IEC/TR 62366-2:2016 Medical devices Guidance on the application of usability engineering to medical devices
AAMI ISO 80369-1 : 2010 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
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NF EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
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01/560793 DC : DRAFT FEB 2001 IEC/DIS 60601-2-13 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC SYSTEMS
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BS EN 60601-2-44 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009)
09/30192356 DC : 0 BS EN 12470-4:2000/A1 - CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
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BS ISO 10342 : 1997 AMD 10607 OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS
BS 5724-2.27(1989) : 1989 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR OXYGEN ANALYZERS FOR MONITORING PATIENT BREATHING MIXTURES
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ISO 8835-7:2011 Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
13/30245306 DC : 0 BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS
BS EN 60601-1-12:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
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AAMI/IEC TIR61289:2011 HIGH FREQUENCY SURGICAL EQUIPMENT - OPERATION AND MAINTENANCE
BS EN 60601-2-30:2000 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
AAMI EC71 : 2001 : R2013 STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY
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12/30262710 DC : 0 BS EN ISO 10341 - OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS
UNE-EN 60645-6:2010 Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions
10/30205392 DC : 0 BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
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BS EN 60601-2-13:2006 Medical electrical equipment Particular requirements for the safety and essential performance of anaesthetic systems
BS EN 61910-1:2014 Medical electrical equipment. Radiation dose documentation Radiation dose structured reports for radiography and radioscopy
03/311987 DC : DRAFT AUG 2003 BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
CEI EN 60601-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
AAMI ID26:2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
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I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
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BIS IS/ISO 10524-3 : 2005 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
ASTM F 1464 : 1993 : R1999 Standard Specification for Oxygen Concentrators for Domiciliary Use
04/30107378 DC : DRAFT JUL 2004 EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
NF EN ISO 15752 : 2010 OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY
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BIS IS/ISO 10079-3 : 1999 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE
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AAMI ID26 : 2004 : R2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
04/30088362 DC : DRAFT NOV 2004 ISO 10651-5 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY VENTILATORS
AAMI TIR59:2017 INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
NF EN 61910-1 : 2015 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
07/30152116 DC : 0 BS EN 62467-1 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
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BS EN 60601-2-40:1998 Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment
CSA Z10079.1 : 2003 : R2013 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS
CSA Z17510.1 : 2010 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CSA Z10535 : 2003 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 10524-1:2006-05 PRESSURE REGULATORS FOR USE WITH MEDICAL GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
DIN EN ISO 18397:2016-09 DENTISTRY - POWERED SCALER (ISO 18397:2016)
AAMI EC38 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS
CSA Z9919 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
UNE-EN ISO 80601-2-69:2015 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
EN ISO 19980:2012 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
ASTM F 1415 : 1992 : R2000 Standard Specification for Pulse Oximeters (Withdrawn 2005)
BIS IS 13450-1-3 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - SECTION 3: COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ISO 13091-1:2001 Mechanical vibration Vibrotactile perception thresholds for the assessment of nerve dysfunction Part 1: Methods of measurement at the fingertips
AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
I.S. EN 60598-2-25:1996 LUMINAIRES - PART 2: PARTICULAR REQUIREMENTS - SECTION 25: LUMINAIRES FOR USE IN CLINICAL AREAS OF HOSPITALS AND HEALTH CARE BUILDINGS
I.S. EN ISO 81060-1:2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
I.S. EN ISO 11073-10419:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION PART 10419: DEVICE SPECIALIZATION - INSULIN PUMP (ISO/IEEE 11073-10419:2016)
I.S. EN ISO 11073-10424:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10424: DEVICE SPECIALIZATION - SLEEP APNOEA BREATHING THERAPY EQUIPMENT (SABTE) (ISO/IEEE 11073-10424:2016)
I.S. EN 60645-7:2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSES
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
BS EN ISO 11073-10424:2016 Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE)
I.S. EN 61331-1:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS
CSA ISO 9703-2 : 0 ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 2: AUDITORY ALARM SIGNALS
I.S. EN ISO 26782:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
EN ISO 22374:2005 Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005)
BS EN 60335-2-69:2012 Household and similar electrical appliances. Safety Particular requirements for wet and dry vacuum cleaners, including power brush for commercial use
CSA C22.2 No. 60601.1.1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
I.S. EN 60601-1-6:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
I.S. EN 60601-1-10:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
IEC TR 62348:2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
I.S. EN ISO 10524-4:2008 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS
BS EN 62464-1:2007 Magnetic resonance equipment for medical imaging Determination of essential image quality parameters
I.S. EN 60601-2-24:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
I.S. EN 60601-2-66:2015 MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
BS EN ISO 80601-2-12:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators
I.S. ISO 7396:1989 NON-FLAMMABLE MEDICAL GAS PIPELINE SYSTEMS
CSA C22.2 No. 60601.1.1 : 2002 : R2006 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
BS EN 60601-1-6 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
CSA ISO TR 13154 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH
ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
UNI CEI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
ISO 16571:2014 Systems for evacuation of plume generated by medical devices
CSA ISO 5362 : 2014 ANAESTHETIC RESERVOIR BAGS
I.S. EN 60601-2-64:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
UNI EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
UNI EN ISO 22665 : 2013 OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE
AAMI CN6 : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
CSA ISO 10079-3:14 (R2019) Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)
I.S. EN ISO 22665:2012 OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE (ISO 22665:2012)
BS EN ISO 11073-10427:2018 Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices
I.S. EN 61391-2:2010 ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE
IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
ASTM F 1101 : 1990 : R1996 Standard Specification for Ventilators Intended for Use During Anesthesia
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNE-EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)
DIN EN 60601-2-40 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT
NF EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
NF EN ISO 26782 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
CEI EN 62467-1 : 2016 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
CSA C22.2 No. 60601.2.26 : 2014(R2018) MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIS SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
NF EN 60601 2-6 : 2015 AMD 1 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT
CSA C22.2 No. 60601.2.51 : 2004 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
UNI CEI EN 980 : 2009 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
CSA Z23500 : 2016 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
ASTM F 1452 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
ASTM F 1464 : 1993 : R2005 Standard Specification for Oxygen Concentrators for Domiciliary Use (Withdrawn 2014)
I.S. EN 61674:2013 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING (IEC 61674:2012 (EQV))
ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
DIN EN ISO 10944:2010-01 Ophthalmic instruments - Synoptophores (ISO 10944:2009)
DIN EN ISO 9680 E : 2015 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
DIN EN ISO 19980 E : 2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS (ISO 19980:2012)
DIN EN ISO 10342:2010-11 Ophthalmic instruments - Eye refractometers (ISO 10342:2010)
DIN EN ISO 7376:2010-01 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN ISO 11143:2008-10 DENTISTRY - AMALGAM SEPARATORS
BS EN ISO 10650-1:2005 Dentistry. Powered polymerization activators Quartz tungsten halogen lamps
IEC 60601-2-9:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
15/30319022 DC : 0 BS EN 60990 ED 3.0 - METHODS OF MEASUREMENT OF TOUCH CURRENT AND PROTECTIVE CONDUCTOR CURRENT
UNE-EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
UNE-EN 12312-14:2015 Aircraft ground support equipment - Specific requirements - Part 14: Disabled/incapacitated passenger boarding vehicles
ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
BS EN ISO 7494:1998 Dental units
09/30162904 DC : 0 BS EN 61204-3 - LOW-VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 3: ELECTROMAGNETIC COMPATIBILITY (EMC)
BS EN ISO 8359 : 2009 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
BS EN ISO 11498:2000 Dental handpieces. Dental low-voltage electric motors
UNE-EN 61331-1:2015 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials
UNE-EN ISO 11252:2013 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013)
UNE-EN 61331-2:2015 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
ISO 13958:2014 Concentrates for haemodialysis and related therapies
UNE-EN 61140:2017 Protection against electric shock - Common aspects for installation and equipment
UNE-EN 60335-2-69:2013 Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush for commercial use
ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
BS EN ISO 22523:2006 External limb prostheses and external orthoses. Requirements and test methods
BS EN ISO 15001:2011 Anaesthetic and respiratory equipment. Compatibility with oxygen
BS ISO 7176-14:2008 Wheelchairs Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
BS EN ISO 11904-1:2002 Acoustics. Determination of sound immission from sound sources placed close to the ear. Technique using a microphone in a real ear (MIRE technique)
BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
BS EN ISO 7376 : 2009-08 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
BS EN ISO 10343:2014 Ophthalmic instruments. Ophthalmometers
PD IEC/TR 62354:2014 General testing procedures for medical electrical equipment
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
ISO 22665:2012 Ophthalmic optics and instruments - Instruments to measure axial distances in the eye
BS EN ISO 16201:2006 Technical aids for disabled persons. Environmental control systems for daily living
DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN 61223-2-6:2007 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
I.S. EN ISO 10535:2006 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12470-3:2000-04 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
I.S. EN ISO 18777:2009 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN ISO 10524-2:2006-07 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
I.S. EN ISO 10939:2017 OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017)
CEN/TS 14507-1:2003 Inhalational nitric oxide systems - Part 1: Delivery systems
DIN EN ISO 23328-2:2009-07 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
EN 60645-7:2010 Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses
EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
BS 4743:1979 Specification for safety requirements for electronic measuring apparatus
NF EN 60522 : 2003 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
EN 61168 : 1994 Radiotherapy simulators - Functional performance characteristics
NF EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
EN 61027 : 1993 SPECIFICATION FOR INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
EN 60601-2-26:2015 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
EN ISO 10942:2006 Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006)
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
OVE/ONORM EN 60601-1-10 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
EN 12182:2012 Assistive products for persons with disability - General requirements and test methods
IEC 61204-3:2016 RLV Low-voltage switch mode power supplies - Part 3: Electromagnetic compatibility (EMC)
EN 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
EN 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
EN ISO 80601-2-13:2012 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
EN 60627:2015 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
NF EN 61223-3-5 : 2005 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
EN 61391-2:2010 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
DIN EN ISO 19980:2012-07 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
EN ISO 9680:2014 Dentistry - Operating lights (ISO 9680:2014)
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
EN 60601-3-1:1996 Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
EN 60645-5:2005 Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance
EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
EN 61558-2-16:2009/A1:2013 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1 100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS (IEC 61558-2-16:2009/A1:2013)
EN 61331-1:2014 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials
EN 61223-3-3:1996 Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)
EN 62467-1:2015 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
NF EN 60601-2-26 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
EN ISO 21647:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
EN 61953 : 1998 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF MAMMOGRAPHIC ANTI-SCATTER GRIDS
EN 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
EN 61669:2016 Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids
UNI EN ISO 19980 : 2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS
I.S. EN ISO 16201:2006 TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING
NF EN ISO 16201 : 2007 TECHNICAL AIDS FOR PERSONS WITH DISABILITY - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING
ONORM EN ISO 11608-4 : 2007 PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
NF EN 12182 : 2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
AAMI TIR26 : 2000 VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
XP CEN/TS 14507-2 : 2003 XP INHALATION NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS
BS EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
DIN EN 60580:2001-12 Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000
ONORM EN ISO 15004-1 : 2009 OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
CSA Z10524-2 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
UNI EN ISO 26782 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
BS EN ISO 80601-2-13:2012 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
BS EN 60417-1:1999 Graphical symbols for use on equipment Overview and application
I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
09/30173644 DC : 0 BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
I.S. EN ISO 8359:2009 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS (ISO 8359:1996)
07/30157348 DC : 0 BS ISO 26782 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE ASSESSMENT OF PULMONARY FUNCTION IN HUMANS
I.S. EN 82304-1:2017 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
ISO/IEEE 11073-10425:2016 Health informatics Personal health device communication Part 10425: Device specialization Continuous glucose monitor (CGM)
BS ISO 7494 : 96 AMD 9861 DENTAL UNITS
BS EN ISO 5359 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
BS EN 61223-3-5:2004 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of computed tomography X-ray equipment
CEI EN 60601-2-24 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
ISO 16971:2015 Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye
BS EN ISO 8836:2014 Suction catheters for use in the respiratory tract
06/30136646 DC : DRAFT FEB 2006 ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
DIN EN ISO 15752:2010-05 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
CEI EN 61391-2 : 2011 ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE
BS 5724-1.4(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
I.S. EN ISO 7785-1:1999 DENTAL HANDPIECES - PART 1: HIGH-SPEED AIR TURBINE HANDPIECES
BS EN 60601-2-38:1997 Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds
BS ISO 14835-2:2005 Mechanical vibration and shock. Cold provocation tests for the assessment of peripheral vascular function Measurement and evaluation of finger systolic blood pressure
I.S. EN ISO 11498:1999 DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRICAL MOTORS
16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
15/30322732 DC : 0 BS EN 60601-2-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS - PROPOSED HORIZONTAL STANDARD
CEI EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
OIML R 115 : 1995 CLINICAL ELECTRICAL THERMOMETERS WITH MAXIMUM DEVICE
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
04/30115525 DC : DRAFT JUN 2004 PREN 12312-14 - AIRCRAFT GROUND SUPPORT EQUIPMENT - PART 14: DISABLED INCAPACITATED PASSENGER BOARDING EQUIPMENT
11/30206856 DC : 0 BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
UNI EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
BS EN 60645-6:2010 Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions
14/30284310 DC : 0 BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS
DD CEN/TS 14507-1:2003 Inhalational nitric oxide systems Delivery systems
DIN EN ISO 26782:2010-02 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)
16/30329598 DC : 0 BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS
BS ISO 10651-5:2006 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators
UNI EN ISO 7376 : 2009-10 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
PD IEC/TR 80001-2-9:2017 Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
BS ISO/IEEE 11073-10441 : 2015 COR 2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR
BS EN 61223-3-4:2000 Evaluation and routine testing in medical imaging departments Acceptance tests
BS EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
17/30357644 DC : 0 BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE
UNE-EN ISO 80369-1:2011 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
14/30313972 DC : 0 BS EN 60645-1 ED.4.0 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY
14/30287753 DC : 0 BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
BS ISO 14835-1:2016 Mechanical vibration and shock. Cold provocation tests for the assessment of peripheral vascular function Measurement and evaluation of finger skin temperature
03/114562 DC : DRAFT SEP 2003 BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
11/30239319 DC : 0 BS EN ISO 22665 - OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE
BS 5724-2.31(1995) : 1995 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
11/30233851 DC : 0 BS EN ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
AAMI TIR66 : 2017 GUIDANCE FOR THE CREATION OF PHYSIOLOGIC DATA AND WAVEFORM DATABASES TO DEMONSTRATE REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF ALARM SYSTEM ALGORITHMS
03/111613 DC : DRAFT AUG 2003 BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
15/30288418 DC : 0 BS EN ISO 80369-2 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS
UNE-EN 60601-2-66:2016 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
02/564924 DC : DRAFT NOV 2002 ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
DD ENV 1064:1994 Medical informatics. Standards communications protocol. Computer-assisted electrocardiography
DIN EN ISO 22665:2013-04 OPHTHALMIC OPTICS AND INSTRUMENTS - INSTRUMENTS TO MEASURE AXIAL DISTANCES IN THE EYE (ISO 22665:2012)
UNI EN ISO 81060-2 : 2014 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
BS EN 60627:2015 Diagnostic X-ray imaging equipment. Characteristics of general purpose and mammographic anti-scatter grids
ANSI Z80.23 : 2008 OPHTHALMICS - CORNEAL TOPOGRAPHY SYSTEMS - STANDARD TERMINOLOGY, REQUIREMENTS
DIN EN ISO 15002:2008-11 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
UNI EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
UNI ISO 14835-2 : 2010 MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 2: MEASUREMENT AND EVALUATION OF FINGER SYSTOLIC BLOOD PRESSURE
PD ISO/TR 21730:2007 Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
12/30259708 DC : 0 BS EN ISO 5356-1 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO/DIS 5356-1:2012)
EN 82304-1:2017 Health Software - Part 1: General requirements for product safety
ANSI Z80.11:2012 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
17/30323851 DC : 0 BS ISO 19894 - WALKING TROLLEYS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 22374:2005-12 DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS
04/30112949 DC : DRAFT APR 2004 IEC 60825-8 ED.2 - SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE USE OF MEDICAL LASER EQUIPMENT
DIN EN ISO 13958:2016-03 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
CAN/CSA-Z15002:12 (R2017) Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations)
BS EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
BS 5724-2.40(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
04/30110485 DC : DRAFT MARCH 2004 ISO 14835-2 - MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 2 - MEASUREMENT AND EVALUATION OF FINGER SYSTOLIC BLOOD PRESSURE
02/206610 DC : DRAFT MAY 2002 IEC 61010-2-040. ED.1 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS
BS EN 60601-2-66:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
PD ISO/TR 13154:2017 Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
BS 5724-2.38(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
12/30271196 DC : 0 BS EN 60601-1-10:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
03/302031 DC : DRAFT FEB 2003 BS EN 60789 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS AND TEST CONDITIONS OF RADIONUCLIDE IMAGING DEVICES - ANGER TYPE GAMMA CAMERAS
BS EN 45502-2-3:2010 Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems
13/30270468 DC : 0 BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
06/30160368 DC : 0 BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT
CSA Z1500:2012 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
BS 5724-2.202(1997) : 1997 + A2 2009 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
CEI EN 61689 : 2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
CSA C22.2 No. 60601.1.8 : 2008 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
PREN ISO 5356-1 : DRAFT 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO/DIS 5356-1:2012)
PD IEC/TR 60601-4-4:2017 Medical electrical equipment Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements
BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS 5724-2.24(1989) : 1989 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR HUMIDIFIERS
CSA Z9360.1 : 2007 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
05/30114976 DC : DRAFT FEB 2005 ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
ASTM F 882 : 1984 : R2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
PD IEC/TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
CEI EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
BS ISO 81060-1 : 2007 COR 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
BS EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications
IEC 80601-2-71:2015 Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
03/111581 DC : DRAFT JULY 2003 BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS
06/30137313 DC : 0 ISO/IEC 81060-1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR MECHANICAL TYPE
CSA Z10651-5 : 2008 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
09/30181956 DC : DRAFT MAY 2009 BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
BS EN 61689:2013 Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
BS EN 61675-2:2015 Radionuclide imaging devices. Characteristics and conditions Gamma cameras for planar, wholebody, and SPECT imaging
CSA Z10535 : 2003 : R2014 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
CEI EN 60335-2-69 : 2014 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-69: PARTICULAR REQUIREMENTS FOR WET AND DRY VACUUM CLEANERS, INCLUDING POWER BRUSH, FOR COMMERCIAL USE
CSA ISO 81060-2 : 2014 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
DIN EN ISO 81060-1:2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
CEI EN 60645-1 : 2016 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY
GOST R IEC 60627 : 2005 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
NF EN 60601-1-11 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
CSA Z21647 : 2007 : R2012 : FR MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
DIN 6855-11:2016-08 CONSTANCY TESTING OF NUCLEAR MEDICINE INSTRUMENTS - PART 11: RADIONUCLIDE CALIBRATORS (IEC/TR 61948-4:2006, MODIFIED)
AAMI ISO 13958 : 2009 CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES
ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
IEC 61204-3 REDLINE : 3ED 2016 LOW-VOLTAGE SWITCH MODE POWER SUPPLIES - PART 3: ELECTROMAGNETIC COMPATIBILITY (EMC)
PD IEC/TR 60601-4-3:2015 Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
IEC TS 60479-1:2005+AMD1:2016 CSV Effects of current on human beings and livestock - Part 1: Generalaspects
ISO 11197:2016 Medical supply units
ISO 7176-14:2008 Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters Requirements and test methods
NF EN 60601-1-1 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
I.S. EN 60601-2-26:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
ISO 14835-2:2005 Mechanical vibration and shock — Cold provocation tests for the assessment of peripheral vascular function — Part 2: Measurement and evaluation of finger systolic blood pressure
UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
CSA C22.2 No. 60601-2-64 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
UNE-EN 60645-7:2010 Electroacoustics - Audiometric equipment -- Part 7: Instruments for the measurement of auditory brainstem responses
AAMI ISO 10079-1 : 1999 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS
I.S. EN 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
I.S. EN 61689:2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ (IEC 61689:2013 (EQV))
BS EN ISO 10637:2000 Dental equipment. High and medium volume suction systems
AAMI ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
I.S. EN 61558-2-16:2009 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS
I.S. EN ISO 14457:2017 DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
BS EN 60601-1-8 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006)
I.S. EN 62353:2014 MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
CEI EN 60601-2-9 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
UNI EN ISO 80601-2-61 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
I.S. EN 60645-6:2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
I.S. EN 16812:2016 TEXTILES AND TEXTILE PRODUCTS - ELECTRICALLY CONDUCTIVE TEXTILES - DETERMINATION OF THE LINEAR ELECTRICAL RESISTANCE OF CONDUCTIVE TRACKS
BS EN 60601-2-10:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
I.S. ISO 5369:1987 BREATHING MACHINES FOR MEDICAL USE - LUNG VENTILATORS
AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN ISO 80369-3:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014)
I.S. EN 60601-2-36:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
BIS IS/ISO 14708-1 : 2000 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
UNI EN ISO 23328-2 : 2009 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
CEI UNI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
CEI EN 60627 : 2016 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
CSA IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CAN/CSA-ISO 10079-1:16 Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)
CSA ISO 11195 : 2014 GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS
NF EN ISO 80601-2-13 : 2013 AMD 1 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
NF EN 60601 2-13 : 2007 AMD 1 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
BS EN 41003:2009 Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system
CSA Z17510.2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
I.S. EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
BS EN ISO 5367:2014 Anaesthetic and respiratory equipment. Breathing sets and connectors
UNE-EN ISO 14457:2013 Dentistry - Handpieces and motors (ISO 14457:2012)
UNE-EN ISO 5367:2015 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
IEC TR 61948-3:2018 Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
CSA C22.2 No. 601.1.1 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
BS EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications
CSA C22.2 No. 601.2.29 : 0 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY SIMULATORS
CSA C22.2 No. 601.2.31 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
CSA C22.2 No. 60601-1-10 : 2009 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
ANSI Z80.37 : 2017 OPHTHALMICS - SLIT-LAMP MICROSCOPES
NF EN 60613 : 2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
OIML R 114 : 1995 CLINICAL ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
UNE-EN ISO 13958:2016 Concentrates for haemodialysis and related therapies (ISO 13958:2014)
UNI EN ISO 15752 : 2010 OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY
CSA C22.2 No. 60601.2.36 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
NF EN 60601-1-12 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
CSA C22.2 No. 60601-1-10:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
UNI EN ISO 10524-3 : 2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
I.S. EN 61204-7:2006 LOW VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 7: SAFETY REQUIREMENTS
ISO 14971:2007 Medical devices Application of risk management to medical devices
ASTM F 1415 : 1992 Standard Specification for Pulse Oximeters
BS EN ISO 80601-2-61:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment
CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
NF EN ISO 7376 : NOV 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
ISO 11073-91064:2009 Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
I.S. EN 62494-1:2008 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
ANSI/AAMI/IEC TIR62354:2015 GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT
I.S. EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
ISO 8836:2014 Suction catheters for use in the respiratory tract
IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60645-1:2017 Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
DIN EN ISO 6875:2011-10 DENTISTRY - PATIENT CHAIR
DIN EN ISO 8835-4:2009-07 INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES
DIN EN 12182:2012-07 Assistive products for persons with disability - General requirements and test methods
DIN EN ISO 18779 E : 2005 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
DIN EN ISO 17510-2:2009-07 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
DIN EN ISO 8835-2:2009-08 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
DIN EN ISO 18778 E : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
NF EN 13718-2 : 2017 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN ISO 18778:2009-08 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
DIN EN ISO 18777:2009-07 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
BS EN ISO 10535:2006 Hoists for the transfer of disabled persons. Requirements and test methods
UNE-EN ISO 21969:2010 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
BS EN 60789:2005 Medical electrical equipment. Characteristics and test conditions of radionuclide imaging devices. Anger type gamma cameras
UNE-EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
IEC 60601-2-63:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
BS EN ISO 13294:1997 Dental handpieces. Dental air-motors
BS EN ISO 12865:2006 Ophthalmic instruments. Retinoscopes
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
BS EN ISO 12866 : 1999 OPHTHALMIC INSTRUMENTS - PERIMETERS
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
BS EN 1064:2005 Health informatics. Standard communication protocol. Computer-assisted electrocardiography
BS EN ISO 8835-2:2009 Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007)
UNE-EN ISO 23747:2016 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
ISO/IEEE 11073-10441:2015 Health informatics Personal health device communication Part 10441: Device specialization Cardiovascular fitness and activity monitor
ISO 11143:2008 Dentistry Amalgam separators
IEC 60601-2-10:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators
BS EN ISO 9360-1:2009 Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans HMEs for use with minimal tidal volumes of 250 ml
DIN EN ISO 9680:2015-02 Dentistry - Operating lights (ISO 9680:2014)
UNE-EN ISO 10940:2010 Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
UNE-EN 61331-3:2015 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields
BS EN 12470-3 : 2000 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
IEC 61223-3-3:1996 Evaluation and routine testing in medical imaging departments -Part 3-3: Acceptance tests - Imaging performance of X-ray equipmentfor digital subtraction angiography (DSA)
DIN EN ISO 11608-4:2016-03 (Draft) PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
DIN EN ISO 10650-2:2007-11 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS
EN 13819-2:2002 Hearing protectors - Testing - Part 2: Acoustic test methods
I.S. EN ISO 10942:2006 OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES
I.S. EN 12184:2014 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
I.S. EN ISO 10343:2014 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014)
I.S. EN ISO 23747:2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
I.S. EN 12312-14:2014 AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES
I.S. EN ISO 8612:2009 OPHTHALMIC INSTRUMENTS - TONOMETERS
I.S. EN ISO 18778:2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
DIN EN 12470-4:2001-02 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
I.S. EN ISO 10940:2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
I.S. EN ISO 12865:2006 OPHTHALMIC INSTRUMENTS - RETINOSCOPES
I.S. EN ISO 11143:2008 DENTISTRY - AMALGAM SEPARATORS
I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
I.S. EN 13819-2:2002 HEARING PROTECTORS - TESTING - PART 2: ACOUSTIC TEST METHODS
I.S. EN 12182:2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7494:1998 DENTAL UNITS
I.S. EN ISO 10943:2011 OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
I.S. EN ISO 17510-2:2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
I.S. EN ISO 11252:2013 LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION (ISO 11252:2013)
I.S. EN ISO 9703-3:1999 ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS
DIN EN ISO 10650-1:2006-01 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS
I.S. EN ISO 15001:2011 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN (ISO 15001:2010)
I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
I.S. EN 61267:2006 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS
I.S. EN 60601-2-17:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
I.S. EN ISO 9680:2014 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
I.S. EN ISO 10342:2010 OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS
I.S. EN ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
I.S. EN ISO 10944:2009 OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES
I.S. EN ISO 10341:2012 OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS (ISO 10341:2012)
UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
I.S. EN ISO 9360-1:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
I.S. EN 60601-1-3:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
DIN EN ISO 10343:1999-07 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014)
I.S. EN ISO 15004-1:2009 OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
DIN EN ISO 10651-2:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
I.S. EN ISO 21969:2009 HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS
I.S. EN 60601-2-33:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
DIN EN 957-6:2001-11 STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS
I.S. EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
I.S. EN ISO 18779:2005 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
I.S. EN 957-6:2010 STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS
EN ISO 15004-1:2009 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
I.S. EN ISO 10079-3:2014 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014)
DIN EN ISO 8359:2009-08 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
I.S. EN ISO 19980:2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS (ISO 19980:2012)
UNI EN ISO 15001 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
BIS IS/ISO 14708-3 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
VDI 5702 Blatt 1:2017-04 Medical device software - Medical SPICE Process assessment model
OVE/ONORM EN 61223-3-5 : 2005 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
NEMA XR 9-1984 (R1994, R2000) POWER SUPPLY GUIDELINES FOR X-RAY MACHINES
VDE 0750-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
NEMA XR 14-1990 (R1995, R2000) RECOMMENDED PRACTICES FOR LOAD-BEARING MECHANICAL ASSEMBLIES USED IN DIAGNOSTIC IMAGING
NF EN ISO 10942 : 2007 OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES
VDE 0750-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
NEMA/MITA 1:2015 Good Refurbishment Practices for Medical Imaging Equipment
NF EN ISO 18778 : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
BS 2011-2.1R:1990 Environmental testing. Tests Test R and guidance. Water
NEMA RT 1:2014 Gating Interface
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DIN EN 60601-2-35 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
CSA Z10524-2 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
UNI EN ISO 81060-1 : 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
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CSA Z23747 : 2008 : R2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
CSA Z10524-1 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
13/30260084 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
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NF EN ISO 8835-3 : 2009 AMD 1 2011 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
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PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
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AAMI ISO 81060-2 : 2013 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
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05/30098700 DC : DRAFT JUL 2005 ISO 9680 - DENTAL OPERATING LIGHT
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SAE AS 8059 : 2012 CARRY-ON PORTABLE OXYGEN CONCENTRATORS
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BS 7698-12:1998 Reciprocating internal combustion engine driven alternating current generating sets Emergency power supply to safety devices
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NF ISO 13091-1 : 2003 AMD 1 2010 MECHANICAL VIBRATION - VIBROTACTILE PERCEPTION THRESHOLDS FOR THE ASSESSMENT OF NERVE DYSFUNCTION - PART 1: METHOD OF MEASUREMENT AT THE FINGERTIPS
CSA CEI/IEC 1289.1 : 1998 HIGH-FREQUENCY SURGICAL EQUIPMENT - PART 1: OPERATION
XP CEN/TS 14507-1 : 2003 XP INHALATION NITRIC OXIDE SYSTEMS - PART 1 : DELIVERY SYSTEMS
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11/30227744 DC : DRAFT SEP 2011 BS EN 60627 - DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
03/304751 DC : DRAFT APR 2003 IEC 61223-3-5 ED.1.0 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
NF EN 60645-7 : 2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSES
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CEI EN 60580 : 2001 MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS
BS EN 60601-2-32:1995 Medical electrical equipment. Particular requirements for safety Specification for associated equipment of X-ray equipment
BS 7887:1997 Ultrasonics. Real-time pulse-echo systems. Guide for test procedures to determine performance specifications
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04/30088533 DC : DRAFT MARCH 2004 BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
IEEE 1073.4.1 : 2000 STANDARD FOR MEDICAL DEVICE COMMUNICATIONS - PHYSICAL LAYER INTERFACE - CABLE CONNECTED
IEEE DRAFT 1073.2 : SEP 95 MEDICAL DEVICES COMMUNICATIONS, APPLICATION PROFILES (MDAP) - FRAMEWORK AND OVERVIEW
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AAMI ISO 23500 : 2011 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
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AAMI ISO 10079-3 : 1999 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE
AAMI ISO 81060-1:2007(R2013) NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
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XP ISO/TS 22595-1 : 2007 XP DENTISTRY - PLANT AREA EQUIPMENT - PART 1: SUCTION SYSTEMS
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BS EN 60601-1-4:1997 Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems
AAMI IEC 62366 : 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
04/30099768 DC : DRAFT DEC 2004 PREN ISO 8835-3 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: ANAESTHETIC GAS SCAVENGING SYSTEMS - TRANSFER AND RECEIVING SYSTEMS
CSA Z18779 : 2008 : R2013 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
CSA IEC 62366 : 2014 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI IEC 60601-2-20 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSPORT INCUBATORS
ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
CEI EN 60976 : 2009 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 20072 : 2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
07/30173584 DC : 0 BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS
BS 5724-2.119(1991) : 1991 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BABY INCUBATORS
03/106547 DC : DRAFT APR 2003 ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS
UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
BS EN ISO 81060-2:2014 Non-invasive sphygmomanometers Clinical investigation of automated measurement type
CSA Z10524-4 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
AAMI ID26 : 2004 : R2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
UNE-EN 60601-1-6:2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
BS EN 60601-1-10 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
06/30145777 DC : DRAFT FEB 2006 ISO 10650-2 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS
BS EN ISO 11073-30400:2012 Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet
BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
BS EN 60601-3-1:1997 Medical electrical equipment. Particular requirements for performance Specification for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
DD ISO/TS 11080:2009 Dentistry. Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
DIN EN ISO 80369-7 E : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
AAMI EC71 : 2001 : R2007 STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY
CSA Z9919 :2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
CAN/CSA-Z7376:12 (R2017) Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations)
CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN ISO 80369-7:2017 COR 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
ISO/IEEE 11073-10427:2018 Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices
UNE-EN ISO 80601-2-56:2013 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
DIN EN ISO 13958 E : 2016 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
AAMI IEC 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
CSA C22.2 No. 60601.2.17 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
ISO 18397:2016 Dentistry Powered scaler
ISO 10942:2006 Ophthalmic instruments Direct ophthalmoscopes
BS EN 60731:2012 Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy
IEC 60335-2-69:2016 RLV Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush, for commercial use
IEC 61675-2:2015 Radionuclide imaging devices - Characteristics and test conditions - Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
PREN ISO 80369-1 : DRAFT 2009 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
AAMI ISO 5356-1 : 2004 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS
I.S. EN ISO 10524-1:2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
I.S. EN 60601-1-8:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
I.S. EN ISO 20608:2018 DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018)
AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
I.S. EN ISO 23500:2015 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
I.S. EN ISO 11073-10441:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR (ISO/IEEE 11073-10441:2015)
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
I.S. EN ISO 10637:2000 DENTAL EQUIPMENT - HIGH- AND MEDIUM-VOLUME SUCTION SYSTEMS
I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS EN 60601-2-37 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
I.S. EN 60645-1:2017 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY
ANSI/AAMI/ISO 80369-7:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
I.S. EN 60601-1-12:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
I.S. EN ISO 15752:2010 OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY
AAMI ISO 14708-5 : 2010 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
I.S. EN 61140:2016 PROTECTION AGAINST ELECTRIC SHOCK - COMMON ASPECTS FOR INSTALLATION AND EQUIPMENT
BS EN 62366 : 2008 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI/IEC TIR62296:2009
EN 60601-1-10:2008/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007)
I.S. EN 60601-1-1:2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
I.S. EN ISO 23328-2:2009 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
I.S. EN 60417-1:2002 GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION
EN ISO 11073-10424:2016/AC:2018 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10424: DEVICE SPECIALIZATION - SLEEP APNOEA BREATHING THERAPY EQUIPMENT (SABTE) (ISO/IEEE 11073-10424:2016)
I.S. EN 61910-1:2014 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
CSA C22.2 No. 601.2.26 : 0 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROENCEPHALOGRAPHS
I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
CEI 62-105 : 2000 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2: CONSTANCY TESTS - FILM PROCESSORS
CSA ISO 10079-3 : 2014 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
PREN 12184 : DRAFT 2011 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 10524-3:2013-06 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005 + AMD 1:2013)
EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
I.S. EN 61331-2:2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES
EN 60601-2-43:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
I.S. EN ISO 80601-2-13:2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011)
CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
ASTM F 1690 : 1996 : R2004 Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems (Withdrawn 2013)
AAMI ISO 5362 : 2006 ANAESTHETIC RESERVOIR BAGS
CEI EN 60601-2-17 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
CSA C22.2 No. 601.2.19 : 1992 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
ASTM F 1101 : 1990 : R2003 : EDT 1 Standard Specification for Ventilators Intended for Use During Anesthesia (Withdrawn 2012)
CSA Z8835.2 : 2008 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS
HD 395.2.7 : 200S1 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
ASTM F 1456 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Capnometers
EN ISO 7488:2018 Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
EN ISO 80601-2-55:2018 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
BS EN ISO 10524-2:2006 Pressure regulators for use with medical gases Manifold and line pressure regulators
EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
I.S. EN 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
ISO 80601-2-55:2018 Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
I.S. EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
IEC TR 63167:2018 Assessment of contact current related to human exposure to electric, magnetic and electromagnetic fields
ISO 22374:2005 Dentistry Dental handpieces Electrical-powered scalers and scaler tips
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
IEC TR 62653:2012 Guideline for safe operation of medical equipment used for haemodialysis treatments
I.S. EN 60645-5:2005 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
NF EN ISO 19980 : 2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS
IEC 60335-2-69:2016 Household and similar electrical appliances - Safety - Part 2-69: Particular requirements for wet and dry vacuum cleaners, including power brush, for commercial use
I.S. EN 62041:2010 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND COMBINATIONS THEREOF - EMC REQUIREMENTS
IEC 60601-2-75:2017 Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
I.S. EN 62304:2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
I.S. EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
DIN EN ISO 18777 E : 2009 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
DIN EN 12470-3:2009-11 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN 12470-4:2009-11 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
DIN EN ISO 10651-6:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 12865:2006-10 Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
DIN EN ISO 12866:2009-03 OPHTHALMIC INSTRUMENTS - PERIMETERS
DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
DIN EN ISO 15001:2012-06 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
IEC 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
BS EN 957-1:2005 Stationary training equipment General safety requirements and test methods
BS EN ISO 9919:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
IEC 60645-6:2009 Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
IEC 60645-7:2009 Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses
ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
BS EN ISO 15606:2000 Dental handpieces. Air-powered scalers and scaler tips
BS EN ISO 9703-3:1999 Anaesthetic and respiratory care alarm signals Guidance on application of alarms
ISO 7785-2:1995 Dental handpieces Part 2: Straight and geared angle handpieces
IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
BS EN ISO 10939:2017 Ophthalmic instruments. Slit-lamp microscopes
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN ISO 23747:2015 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
IEC 60601-2-37:2007+AMD1:2015 CSV Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
BS EN ISO 11196:1997 Anaesthetic gas monitors
BS EN 60601-2-17:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
ISO 10650-2:2007 Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
UNE-EN ISO 10943:2012 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
UNE-HD 60364-7-710:2014 Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
BS EN 12470-5:2003 Clinical thermometers Performance of infra-red ear thermometers (with maximum device)
DIN EN 13976-1 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
BS EN 957-6 : 2010 STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS
UNE-EN ISO 8612:2010 Ophthalmic instruments - Tonometers (ISO 8612:2009)
BS EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
UNE-EN ISO 26782:2010 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
IEC 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
IEC 60645-5:2004 Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance
IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
ISO 10939:2017 Ophthalmic instruments — Slit-lamp microscopes
IEC 61331-1:2014 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials
I.S. EN 1064:2005 HEALTH INFORMATICS - STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY
EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
NASA STD 3001 VOL 2 : 2015 NASA SPACE FLIGHT HUMAN-SYSTEM STANDARD - VOLUME 2: HUMAN FACTORS, HABITABILITY, AND ENVIRONMENTAL HEALTH
NASA JSC 08080-2 : 2015 JSC DESIGN AND PROCEDURAL STANDARDS
I.S. EN ISO 7376:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
EN 41003:2008 Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system
EN 1064:2005+A1:2007 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN 60601-1-12:2015 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
I.S. EN 1820:2005 ANAESTHETIC RESERVOIR BAGS
EN 60601-1-9:2008/A1:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013)
EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
UNI EN 12470-3 : 2009 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNI EN 12470-4 : 2009 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
UNI EN ISO 10341 : 2013 OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS
UNI EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR
UNI EN ISO 11252 : 2013 LASERS AND LASER-RELATED EQUIPMENT - LASER DEVICE - MINIMUM REQUIREMENTS FOR DOCUMENTATION
UNI EN ISO 21647 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
UNI EN ISO 10343 : 2014 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS
EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN ISO 11904-1 : 2006 ACOUSTICS - DETERMINATION OF SOUND IMMISSION FROM SOUND SOURCES PLACED CLOSE TO THE EAR - PART 1: TECHNIQUE USING A MICROPHONE IN A REAL EAR (MIRE TECHNIQUE)
CSA Z8835.4 : 2006 INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES
UNI EN ISO 10342 : 2010 OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS
UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN ISO 10944 : 2009 OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES
UNI EN ISO 10651-2 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
UNI EN ISO 8835-5 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
UNI EN ISO 10943 : 2011 OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
UNI EN 12184 : 2014 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
UNI EN ISO 17510-2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
UNI EN ISO 12866 : 2009 OPHTHALMIC INSTRUMENTS - PERIMETERS
UNI EN ISO 10940 : 2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
UNI EN ISO 9360-1 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
UNI EN ISO 10079-3 : 2014 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
UNI EN ISO 21969 : 2010 HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS
UNI EN 12312-14 : 2014 AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES
UNI EN ISO 18777 : 2009 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
I.S. EN ISO 11608-4:2007 PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
EN ISO 9919:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
UNI EN ISO 9919 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
UNI EN 957-6 : 2014 STATIONARY TRAINING EQUIPMENT - PART 6: TREADMILLS, ADDITIONAL SPECIFIC SAFETY REQUIREMENTS AND TEST METHODS
UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI CEI EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
UNI EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
UNI EN 794-1 : 2009 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
UNI EN ISO 18778 : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
UNI EN 12182 : 2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 1820 : 2009 ANAESTHETIC RESERVOIR BAGS
UNI EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
UNI EN ISO 8612 : 2009 OPHTHALMIC INSTRUMENTS - TONOMETERS
UNI EN ISO 8359 : 2012 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
UNI EN ISO 8835-4 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES
UNI EN ISO 11143 : 2008 DENTISTRY - AMALGAM SEPARATORS
UNE-EN 60601-2-44:2010 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
CEI EN 60522 : 2001 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
I.S. EN ISO 13958:2015 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
CSA C22.2 No. 60601-1-9 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN
ANSI/AAMI HA60601-1-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018) Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)
ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
16/30342393 DC : 0 BS EN 60601-2-65:2013/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
CSA Z23747:2008 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS ISO 7176-9:2009 Wheelchairs Climatic tests for electric wheelchairs
12/30258857 DC : 0 BS EN 60601-1-6/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
14/30277509 DC : 0 BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS
IEEE 11073-10419-2015 IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump
BS 5724-2.120(1991) : 1991 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR TRANSPORT INCUBATORS
EN ISO 5359:2014/A1:2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017)
14/30244508 DC : 0 BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
08/30192448 DC : DRAFT DEC 2008 BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
17/30338753 DC : 0 BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT
BS EN ISO 80601-2-72:2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
NF EN ISO 80601-2-72 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
DIN 6875-20:2016-08 SPECIAL RADIOTHERAPY EQUIPMENTS - PART 20: PROTON THERAPY - RULES FOR CONSTRUCTION OF STRUCTURAL RADIATION PROTECTION
CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
13/30250915 DC : 0 BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
NF EN 60601-2-66 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
06/30147232 DC : DRAFT OCT 2006 IEC 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
03/111582 DC : DRAFT JULY 2003 BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
13/30216789 DC : 0 BS EN 60601-2-64 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL LIGHT ION BEAM MEDICAL EQUIPMENT
I.S. EN ISO 21647:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
BS ISO 10343 : 1997 AMD 10608 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS
08/30170500 DC : DRAFT JUNE 2008 BS EN 60601-2-33 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
I.S. EN ISO 7785-2:1998 DENTAL HANDPIECES - PART 2: STRAIGHT AND GEARED ANGLE HANDPIECES
BS ISO 18835:2015 Inhalational anaesthesia systems. Draw-over anaesthetic systems
I.S. EN 62274:2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
16/30332194 DC : 0 BS ISO 10936-1 - OPTICS AND PHOTONICS - OPERATION MICROSCOPES - PART 1: REQUIREMENTS AND TEST METHODS
UNI EN ISO 8835-2 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
17/30338756 DC : 0 BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
13/30264413 DC : 0 BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
12/30271192 DC : 0 BS IEC 60601-1-3 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
NF EN 60601-1-9 : 2008 AMD 1 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN
03/113375 DC : DRAFT AUG 2003 BS EN ISO 22374 - DENTISTRY - DENTAL HANDPIECES - ELECTRICAL-POWERED SCALERS AND SCALER TIPS
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
BS EN ISO 18397:2016 Dentistry. Powered scaler
18/30356489 DC : DRAFT APR 2018 BS EN 60601-1-10:2008 AMENDMENT 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
02/563809 DC : DRAFT SEP 2002 BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
08/30188786 DC : 0 IEC 60613 - ELECTRICAL, THERMAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
I.S. EN ISO 10650-2:2007 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 2: LIGHT-EMITTING DIODE (LED) LAMPS
08/30176438 DC : DRAFT JAN 2008 BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS
05/30134824 DC : 0 EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM)
12/30241725 DC : 0 BS ISO 28057 - DOSIMETRY WITH SOLID THERMOLUMINSCENCE DETECTORS FOR PHOTON AND ELECTRON RADIATIONS IN RADIOTHERAPY
12/30245174 DC : 0 BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
09/30194820 DC : 0 BS EN 60731 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
PD IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
BS 7259-2(1993) : AMD 9349 NON-ELECTRICAL MEDICAL SUCTION EQUIPMENT - SPECIFICATION FOR SUCTION EQUIPMENT POWERED FROM VACUUM OR PRESSURE SOURCE
BS ISO 11498 : 1997 AMD 10705 DENTAL HANDPIECES - DENTAL LOW-VOLTAGE ELECTRIC MOTORS
BS ISO 81060-2 : 2013 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
07/30173580 DC : 0 BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
AAMI 23500 : 2014 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ANSI/AAMI/IEC TIR80001-2-1:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
BS EN 60601-2-24:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
I.S. EN 61010-2-040:2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS
15/30322764 DC : 0 BS EN 60601-2-6 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT - PROPOSED HORIZONTAL STANDARD
CEI EN 62041 : 2012 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND COMBINATIONS THEREOF - EMC REQUIREMENTS
09/30155521 DC : 0 BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
AAMI NS4 :2013 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS
14/30257546 DC : 0 BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
07/30168606 DC : 0 BS ISO 11073-91064 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 91064: STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY
BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
BS EN 60598-2-25:1995 Luminaires. Particular requirements Luminaires for use in clinical areas of hospitals and health care buildings
BS ISO 8835-2:1999 Inhalational anaesthesia systems Anaesthetic breathing systems for adults
UNE-EN ISO 80369-3:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
CEI EN 60118-14 : 1999 HEARING AIDS - PART 14: SPECIFICATION OF A DIGITAL INTERFACE
BS EN ISO 11073-10441:2017 Health informatics. Personal health device communication Device specialization. Cardiovascular fitness and activity monitor
CSA C22.2 No. 60601.1.1 : 2002 : R2011 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
CSA Z10079.3 : 2003 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE
I.S. EN 60335-2-69:2012 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-69: PARTICULAR REQUIREMENTS FOR WET AND DRY VACUUM CLEANERS, INCLUDING POWER BRUSH FOR COMMERCIAL USE (IEC 60335-2-69:2012 (MOD))
08/30149952 DC : DRAFT MAY 2008 BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
13/30272807 DC : 0 BS ISO 18835 - INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
BS EN 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
PREN ISO 80601-2-55 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
DIN EN ISO 16954:2015-11 DENTISTRY - TEST METHODS FOR DENTAL UNIT WATERLINE BIOFILM TREATMENT (ISO 16954:2015)
12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
BS EN 62041:2010 Safety of transformers, reactors, power supply units and combinations thereof. EMC requirements
UNI EN ISO 15004-1 : 2009 OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
NF EN 60645-6 : 2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
04/30103854 DC : DRAFT JUN 2004 ISO 15004-1 - OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
UNI EN ISO 8835-3 : 2010 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
10/30217545 DC : 0 BS EN 61674 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
BS 5724-2.18(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT
BS EN 60645-1:2017 Electroacoustics. Audiometric equipment Equipment for pure-tone and speech audiometry
I.S. EN 61669:2016 ELECTROACOUSTICS - MEASUREMENT OF REAL-EAR ACOUSTICAL PERFORMANCE CHARACTERISTICS OF HEARING AIDS
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS EN 60645-5:2005 Electroacoustics. Audiometric equipment Instruments for the measurement of aural acoustic impedance/admittance
CEI EN 62083 : 2011 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
BS 7748(1994) : 1994 AMD 9228 SPECIFICATION FOR DENTAL OPERATING LIGHT
03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
07/30145258 DC : 0 BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
11/30237926 DC : 0 BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
14/30291827 DC : DRAFT AUG 2014 BS EN 61675-2 ED.2 - RADIONUCLIDE IMAGING DEVICES - CHARACTERISTICS AND TEST CONDITIONS - PART 2: GAMMA CAMERAS FOR PLANAR IMAGING AND SPECT IMAGING
BS EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
12/30253196 DC : 0 BS EN 60601-2-36 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTRACORPOREALLY INDUCED LITHOTRIPSY
08/30173112 DC : DRAFT AUG 2008 BS EN ISO 8612 - OPHTHALMIC INSTRUMENTS - TONOMETERS
01/561640 DC : DRAFT APR 2001 BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES
NF ISO 16971 : 2015 OPHTHALMIC INSTRUMENTS - OPTICAL COHERENCE TOMOGRAPH FOR THE POSTERIOR SEGMENT OF THE HUMAN EYE - INSTRUMENTS OPHTALMIQUES
CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
NF EN ISO 80601-2-12 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
BS EN ISO 22374:2005 Dentistry. Dental handpieces. Electrical-powered scalers and scaler tips
CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
09/30192353 DC : 0 BS EN 12470-3:2000/A1 - CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
CSA Z15001 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
CAN/CSA-Z18777-08 (R2018) Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations)
CSA Z10079.3:2003 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR PRESSURE SOURCE
CSA Z7376 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
BS EN ISO 16954:2015 Dentistry. Test methods for dental unit waterline biofilm treatment
AAMI ISO 14708-4 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
17/30357890 DC : 0 BS ISO 20495 - TRADITIONAL CHINESE MEDICINE - SKIN ELECTRICAL RESISTANCE MEASUREMENT DEVICE
DIN EN ISO 10650 E : 2016 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
CSA Z21647:2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
CSA Z10651.2: 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
CSA Z18777 : 2008 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
CAN/CSA-Z15001:12 (R2017) Anaesthetic and respiratory equipment - Compatibility with oxygen (Adopted ISO 15001:2010, second edition, 2010-06-01, with Canadian deviations)
ANSI Z80.11 : 2012 : R2017 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
CSA Z10079.1 : 2003 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT - SAFETY REQUIREMENTS
17/30325386 DC : 0 BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS
UNE-EN ISO 15378:2016 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
CEI EN 60601-1-1 : 2003 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
I.S. EN 61168:1994 RADIOTHERAPY SIMULATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI 13958 : 2014 CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES
CSA Z8835.5 : 2006 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS
CSA Z9918 : 0 CAPNOMETERS FOR USE WITH HUMANS - REQUIREMENTS
CSA ISO TS 18835 : 2014 INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT
I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
I.S. EN 61675-2:2015 RADIONUCLIDE IMAGING DEVICES - CHARACTERISTICS AND CONDITIONS - PART 2: GAMMA CAMERAS FOR PLANAR, WHOLEBODY, AND SPECT IMAGING
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
NF EN 60601-1-4 : 1999 AMD 1 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ANSI/AAMI/ISO 14708-1:2014 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ANSI/AAMI/ISO 14708-3:2017 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
AAMI ISO 11195 : 1995 GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS
ANSI/AAMI/ISO 80369-6:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
I.S. EN ISO 15002:2008 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
I.S. EN ISO 80601-2-72:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
NF ISO 18190 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
CSA CEI/IEC 62304:14 (R2019) Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05)
I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
I.S. EN 60601-2-40:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
ASTM F 1831 : 2017 : REDLINE Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
STANAG 2979 : 0 ESSENTIAL CHARACTERISTICS OF ELECTROSURGICAL APPARATUS
EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
ISO 14708-4:2008 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
NF EN 60601 1-3 : 2008 AMD 1 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
UNI EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
BS EN ISO 10524-3 : 2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
I.S. EN 60601-1-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
DIN EN ISO 5367:2015-02 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
GOST R ISO 8528-12 : 2005 RECIPROCATING INTERNAL COMBUSTION ENGINE DRIVEN ALTERNATING CURRENT GENERATING SETS - PART 12: EMERGENCY POWER SUPPLY TO SAFETY SERVICES
NF EN ISO 10637 : 2001 DENTAL EQUIPMENT - HIGH- AND MEDIUM-VOLUME SUCTION SYSTEMS
CEI EN 61266 : 1998 ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING
CEI EN 61674 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
NF EN 60601-2-40 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENTS
I.S. EN 61223-3-5:2004 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-5: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
BS EN ISO 7494-1:2011 Dentistry. Dental units General requirements and test methods
IEEE 11073-10427-2016 IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices
UNI EN ISO 80601-2-55 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
ISO 17966:2016 Assistive products for personal hygiene that support users Requirements and test methods
EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
CEI EN 80001-1 : 2016 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
PD IEC/TR 62809:2013 Summary of requirements and tests for products in the scope of IEC 60601-2-66
CSA C22.2 No. 601.2.32 : 1998 :R 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
NF EN ISO 81060-2 : 2014 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
AAMI ISO 26782 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
ASTM F 1690 : 1996 Standard Specification for Humidifiers for Medical Use-Part 1 General Requirements for Active Humidification Systems
CEI EN 60601-3-1 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 3-1: ESSENTIAL PERFORMANCE REQUIREMENTS FOR TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
DIN EN ISO 10650:2016-02 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
BS EN ISO 11197:2009 Medical supply units
UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
ISO 10524-2:2018 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
EN ISO 20608:2018 Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
ISO 80601-2-70:2015 Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
ISO 28057:2014 Dosimetry with solid thermoluminescence detectors for photon and electron radiations in radiotherapy
ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
DIN EN ISO 80369-1:2015-09 (Draft) SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
ISO 18835:2015 Inhalational anaesthesia systems Draw-over anaesthetic systems
I.S. EN ISO 80601-2-12:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
I.S. EN 60601-2-43:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
I.S. HD 395-2-7:1990 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
IEC 60645-1 REDLINE : 4ED 2017 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AND SPEECH AUDIOMETRY
EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
I.S. EN 60601-2-44:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
IEC PAS 61910-1:2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
IEC 62041:2017 Transformers, power supplies, reactors and similar products - EMC requirements
I.S. EN 60580:2000 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS
I.S. EN 60601-1-9:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007 (EQV))
IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
I.S. EN 60601-2-38:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
IEC 80601-2-59:2017 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
I.S. EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV))
I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
IEC TR 62354:2014 General testing procedures for medical electrical equipment
ISO 10651-5:2006 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators
IEC 61204-3:2016 Low-voltage switch mode power supplies - Part 3: Electromagnetic compatibility (EMC)
EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
EN ISO 80601-2-12:2011/AC:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
UNE-EN 60645-1:2015 Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry
ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
DIN EN ISO 8835-5:2009-07 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS
DIN EN ISO 8612 E : 2010 OPHTHALMIC INSTRUMENTS - TONOMETERS
DIN EN ISO 9360-1 E : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
UNE-EN ISO 6875:2012 Dentistry - Patient chair (ISO 6875:2011)
DIN EN ISO 10079-1:2016-05 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
DIN EN ISO 16201:2006-12 Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006)
DIN EN ISO 15004-1:2009-07 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006); German version EN ISO 15004-1:2009
IEC 60645-1:2017 RLV Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
PD IEC/TS 62850:2013 Safety requirements for electrical equipment for measurement, control, and laboratory use. General requirements for equipment intended to be used in educational establishments by children
BS EN ISO 8185:2007 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment
ISO 18778:2005 Respiratory equipment — Infant monitors — Particular requirements
BS EN 61558-2-16 : 2009 SAFETY OF TRANSFORMERS, REACTORS, POWER SUPPLY UNITS AND SIMILAR PRODUCTS FOR SUPPLY VOLTAGES UP TO 1100 V - PART 2-16: PARTICULAR REQUIREMENTS AND TESTS FOR SWITCH MODE POWER SUPPLY UNITS AND TRANSFORMERS FOR SWITCH MODE POWER SUPPLY UNITS
UNE-EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
BS EN 13819-2:2002 Hearing protectors. Testing Acoustic test methods
BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
IEC 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
IEC 60601-2-65:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
ISO 11904-1:2002 Acoustics — Determination of sound immission from sound sources placed close to the ear — Part 1: Technique using a microphone in a real ear (MIRE technique)
ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
BS EN 1820:2005 Anaesthetic reservoir bags
IEC TS 62850:2013 Safety requirements for electrical equipment for measurement, control, and laboratory use - General requirements for equipment intended to be used in educational establishments by children
ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
EN 60580:2000 Medical electrical equipment - Dose area product meters
ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
ISO 26782:2009 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
BS EN ISO 10651-6:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices
IEC 61331-2:2014 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
BS EN 61267:2006 Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics
ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
ISO 16954:2015 Dentistry — Test methods for dental unit waterline biofilm treatment
BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
BS EN ISO 15004:1998 Ophthalmic instruments. Fundamental requirements and test methods
IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
BS EN ISO 10079-3:2014 Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source
ISO 80601-2-72:2015 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
BS EN ISO 9680:2014 Dentistry. Operating lights
BS EN ISO 7785-1:1999 Dental handpieces High-speed air turbine handpieces
BS EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
BS EN ISO 18778:2009 Respiratory equipment. Infant monitors. Particular requirements
BS EN ISO 7785-2:1998 Dental handpieces Straight and geared angle handpieces
BS EN ISO 11608-4:2007 Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors
IEC 60789:2005 Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras
ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
ISO 15004-1:2006 Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
IEC 60731:2011+AMD1:2016 CSV Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
IEC 60580:2000 Medical electrical equipment - Dose area product meters
BS EN 61140 : 2002 PROTECTION AGAINST ELECTRIC SHOCK - COMMON ASPECTS FOR INSTALLATION AND EQUIPMENT
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
14/30315309 DC : 0 BS EN 61204-3 - LOW VOLTAGE POWER SUPPLIES, D.C. OUTPUT - PART 3: ELECTROMAGNETIC COMPATIBILITY (EMC)
ISO 7785-1:1997 Dental handpieces Part 1: High-speed air turbine handpieces
UNE-EN ISO 10939:2017 Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
ISO 10944:2009 Ophthalmic instruments — Synoptophores
ISO 10650-1:2004 Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps
BS EN 12470-4 : 2001 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
ISO 11608-4:2006 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
IEC 60598-2-25:1994 Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings
I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
ISO 10535:2006 Hoists for the transfer of disabled persons Requirements and test methods
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 10943:2011 Ophthalmic instruments — Indirect ophthalmoscopes
ISO 10341:2012 Ophthalmic instruments — Refractor heads
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
ISO 6875:2011 Dentistry Patient chair
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
IEC 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
BS EN ISO 10651-2:2004 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients
IEC 61266:1994 Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
ISO 10342:2010 Ophthalmic instruments Eye refractometers
ISO 15606:1999 Dental handpieces Air-powered scalers and scaler tips
ISO 12865:2006 Ophthalmic instruments Retinoscopes
ISO 11252:2013 Lasers and laser-related equipment — Laser device — Minimum requirements for documentation
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
ISO/IEEE 11073-30400:2012 Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet
ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
BS EN ISO 6875:2011 Dentistry. Patient chair
IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
IEC 60601-3-1:1996 Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
BS EN ISO 8612:2009 Ophthalmic instruments. Tonometers
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
BS EN 60601-1-3 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)
IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 60601-2-30:1999 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
UNE-EN ISO 19980:2012 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
UNE-EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
IEC 61391-2:2010 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
ISO 8835-4:2004 Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
IEC 61223-3-4:2000 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
BS EN ISO 11073-30200 : 2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED
ISO 10940:2009 Ophthalmic instruments — Fundus cameras
BS EN ISO 10342:2010 Ophthalmic instruments. Eye refractometers
IEC 61674:2012 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS EN ISO 11252:2013 Lasers and laser-related equipment. Laser device. Minimum requirements for documentation
BS EN ISO 10940:2009 Ophthalmic instruments. Fundus cameras
IEC TR 61289:2011 High frequency surgical equipment - Operation and maintenance
ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
UNE-EN ISO 10341:2013 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
BS EN ISO 10650-2:2007 Dentistry. Powered polymerization activators Light-emitting diode (LED) lamps
UNE-EN 62083:2010 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
ISO 8612:2009 Ophthalmic instruments — Tonometers
ISO 7494:1996 Dental units
IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
ISO 12866:1999 Ophthalmic instruments Perimeters
BS EN 61217:2012 Radiotherapy equipment. Coordinates, movements and scales
BS EN ISO 11143:2008 Dental equipment. Amalgam separators
UNE-EN ISO 10343:2014 Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
BS EN 61204-7:2006 Live working. Conductive clothing Safety requirements
BS EN 61223-2-6:2007 Evaluation and routine testing in medical imaging departments Constancy tests. Imaging performance of computed tomography X-ray equipment
ISO 16201:2006 Technical aids for persons with disability — Environmental control systems for daily living
BS EN 60601-2-33 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
IEC 61331-3:2014 Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields
NF EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
ISO 9680:2014 Dentistry Operating lights
UNI EN ISO 80601-2-13 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION
IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
BS EN ISO 10341:2012 Ophthalmic instruments. Refractor heads
ISO/IEEE 11073-20601:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
BS EN 12182:2012 Assistive products for persons with disability. General requirements and test methods
IEC 61027:1991 Instruments for the measurement of aural acoustic impedance/admittance
EN 60601-2-9:1996/corrigendum:1996 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
EN ISO 11073-10419:2016 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
EN ISO 11073-20601:2016 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016)
EN ISO 11904-1 : 2002 ACOUSTICS - DETERMINATION OF SOUND IMMISSION FROM SOUND SOURCES PLACED CLOSE TO THE EAR - PART 1: TECHNIQUE USING A MICROPHONE IN A REAL EAR (MIRE TECHNIQUE)
EN 13826 : 2003 PEAK EXPIRATORY FLOW METERS
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
EN 16812:2016 Textiles and textile products - Electrically conductive textiles - Determination of the linear electrical resistance of conductive tracks
EN ISO 15752:2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
EN ISO 15004 : 1997 OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS
EN ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
EN ISO 12866:1999/A1:2008 Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)
EN ISO 11073-30200:2005/A1:2015 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED (ISO/IEEE 11073- 30200:2004/AMD 1:2015)
EN ISO 15606:1999 Dental handpieces - Air-powered scalers and scaler tips (ISO 15606:1999)
EN ISO 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment (ISO 16954:2015)
EN ISO 16201:2006 Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
EN ISO 10944:2009 Ophthalmic instruments - Synoptophores (ISO 10944:2009)
EN ISO 10939:2017 Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
EN 957-6:2010+A1:2014 Stationary training equipment - Part 6: Treadmills, additional specific safety requirements and test methods
UNI EN ISO 9680 : 2015 DENTISTRY - OPERATING LIGHTS
EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified)
IEC 80601-2-30:2018 RLV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
EN ISO 7785-1:1999 Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN ISO 7494 : 1997 DENTAL UNITS
EN ISO 8835-4:2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
EN ISO 8835-5:2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN ISO 9703-3 : 1998 ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 3: GUIDANCE ON APPLICATION OF ALARMS
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
EN ISO 8359:2009/A1:2012 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS (ISO 8359:1996/AMD 1:2012)
EN ISO 10341:2012 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
EN ISO 8835-3:2009/A1:2010 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
EN ISO 13958:2015 Concentrates for haemodialysis and related therapies (ISO 13958:2014)
EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
EN ISO 10342:2010 Ophthalmic instruments - Eye refractometers (ISO 10342:2010)
EN ISO 10940 : 2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
EN ISO 11143:2008 Dentistry - Amalgam separators (ISO 11143:2008)
EN ISO 13294:1997 Dental handpieces - Dental air-motors (ISO 13294:1997)
EN ISO 7785-2:1997 Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
EN ISO 11073-30400:2012 Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)
EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
EN ISO 10343:2014 Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
EN ISO 22665:2012 Ophthalmic optics and instruments - Instruments to measure axial distances in the eye (ISO 22665:2012)
EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
EN ISO 12865:2006 Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
EN 957-1:2005 Stationary training equipment - Part 1: General safety requirements and test methods
EN ISO 11073-10441:2017 Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015)
EN 794-1:1997+A2:2009 Lung ventilators - Part 1: Particular requirements for critical care ventilators
EN ISO 11498:1999 Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
EN 980:2008 Symbols for use in the labelling of medical devices
EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
EN ISO 10650-1:2005 Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)
EN ISO 10650-2:2007 Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007)
EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
EN ISO 10943:2011 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
EN ISO 23747:2015 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
EN ISO 18397:2016 Dentistry - Powered scaler (ISO 18397:2016)
EN ISO 6875:2011 Dentistry - Patient chair (ISO 6875:2011)
EN ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
I.S. EN ISO 10524-3:2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005)
I.S. EN ISO 10650:2015 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
14/30292011 DC : 0 BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
12/30159217 DC : 0 BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
08/30138766 DC : DRAFT MAR 2008 BS EN ISO 10940 - OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
CSA C22.2 No. 60601.2.24 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
05/30114972 DC : DRAFT FEB 2005 ISO 10942 - OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES
BS 5724-2.124(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
BS EN 60601-1-11:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
BS EN 60601-2-35:1997 Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use
CSA Z10524-3 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
06/30116855 DC : 0 BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT
BS EN 62494-1:2008 Medical electrical equipment. Exposure index of digital X-ray imaging systems Definitions and requirements for general radiography
I.S. EN ISO 10650-1:2005 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS - PART 1: QUARTZ TUNGSTEN HALOGEN LAMPS
PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
I.S. EN 980:2008 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
14/30285182 DC : 0 BS EN ISO 10938 - OPHTHALMIC OPTICS - CHART DISPLAYS FOR VISUAL ACUITY MEASUREMENTS - PRINTED, PROJECTED AND ELECTRONIC
BS 5724-2.39(1999) : 1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT
BS EN ISO 8835-3 : 2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
15/30246774 DC : 0 BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
BS 5966:1980 Specification for audiometers
I.S. EN ISO 8835-5:2009 INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS
IEEE 11073-10441-2013 Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor
BS EN 16812:2016 Textiles and textile products. Electrically conductive textiles. Determination of the linear electrical resistance of conductive tracks
I.S. EN ISO 13294:1998 DENTAL HANDPIECES - DENTAL AIR-MOTORS
CEI EN 62494-1 : 2010 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
I.S. EN ISO 10651-2:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
12/30267985 DC : 0 BS EN 60601-2-33:2010/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
PD IEC/PAS 63077:2016 Good refurbishment practices for medical imaging equipment
NF EN ISO 10524-3 : 2006 AMD 1 2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
UNI EN ISO 10524-4 : 2008 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
ISO/TS 11080:2009 Dentistry Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
02/563295 DC : DRAFT AUG 2002 BS EN ISO 5356-1 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS
14/30245318 DC : 0 BS EN ISO 16954 - DENTISTRY - TEST METHODS FOR EVALUATING ANTIBACTERIAL BIOFILM TREATMENT METHODS FOR DENTAL UNIT WATER DELIVERY SYSTEMS
ANSI Z80.10 : 2014 OPHTHALMIC INSTRUMENTS - TONOMETERS
BS ISO 7176-25:2013 Wheelchairs Batteries and chargers for powered wheelchairs
BS ISO 11197 : 2016 MEDICAL SUPPLY UNITS
14/30273278 DC : 0 BS EN ISO 18397 - DENTISTRY - POWERED SCALER
13/30258863 DC : 0 BS EN 61910-1 ED 1.0 - MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
BS EN ISO 10524-4:2008 Pressure regulators for use with medical gases Low-pressure regulators
I.S. EN ISO 80369-1:2010 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
08/30176368 DC : 0 BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
ISO/TS 10650:1999 Dental equipment Powered polymerization activators
BS EN 61391-2:2010 Ultrasonics. Pulse-echo scanners Measurement of maximum depth of penetration and local dynamic range
UNE-EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
DIN EN 60601-2-32 : 1995 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT
12/30210881 DC : DRAFT APR 2012 BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
DIN 6280-13:1994-12 GENERATING SETS - RECIPROCATING INTERNAL COMBUSTION ENGINES DRIVEN GENERATING SETS - PART 13: FOR EMERGENCY POWER SUPPLY IN HOSPITALS AND PUBLIC BUILDINGS
CSA ISO 11196 : 0 ANAESTHETIC GAS MONITORS
BS 5724-2.35(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR BLANKETS, PADS AND MATTRESSES INTENDED FOR HEATING AND MEDICAL USE
I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
I.S. HD 60364-7-710:2012 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS (IEC 60364-7-710:2002 (MOD))
ISO 14835-1:2016 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature
NF EN 62353 : 2015 MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
CSA Z10651.3 : 0 LUNG VENTILATORS FOR MEDICAL USE - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
BS EN ISO 11073-20601:2016 Health informatics. Personal health device communication Application profile. Optimized exchange protocol
12/30242781 DC : 0 BS EN 61331-2 - PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 2: TRANSLUCENT PROTECTIVE PLATES
07/30156568 DC : DRAFT AUG 2007 BS ISO 12866 AMD1 - OPHTHALMIC INSTRUMENTS - PERIMETERS
ISO/TS 18835:2004 Inhalational anaesthesia systems Draw-over vaporizers and associated equipment
15/30300279 DC : 0 BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
06/30115645 DC : DRAFT JUN 2006 IEC 60601-1-9 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - REQUIREMENTS FOR THE REDUCTION OF ENVIRONMENTAL IMPACTS
BS EN 60645-7:2010 Electroacoustics. Audiometric equipment Instruments for the measurement of auditory brainstem responses
BS EN 61953:1998 Diagnostic X-ray imaging equipment. Characteristics of mammographic anti-scatter grids
BS EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications General requirements
I.S. EN 60601-2-10:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS
BS ISO 23500 : 2014 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
12/30253298 DC : 0 BS EN ISO 10343 - OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS
EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
ANSI/IES RP-29 : 2016 LIGHTING FOR HOSPITALS AND HEALTH CARE FACILITIES
11/30240516 DC : 0 BS EN 12312-14 - AIRCRAFT GROUND SUPPORT EQUIPMENT - SPECIFIC REQUIREMENTS - PART 14: DISABLED/INCAPACITATED PASSENGER BOARDING VEHICLES
EN 60601-2-64:2015 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS EN 61027:1993 Specification for instruments for the measurement of aural acoustic impedance/admittance
16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
BS EN 61331-3:2014 Protective devices against diagnostic medical X-radiation Protective clothing, eyewear and protective patient shields
17/30332162 DC : 0 BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
DIN 19403:2016-08 DENTISTRY - MULTIFUNCTION HANDPIECES
11/30230872 DC : 0 BS EN 61689 - ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
BS EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
00/560888 DC : APR 2000 IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
I.S. EN 60976:2007 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
14/30288421 DC : 0 BS EN ISO/IEC 80369-6 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
NF EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
VDE 0750-2-40 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
IEC 61669:2015 Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids
BS EN 60580:2000 Dose area product meters
DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
15/30322777 DC : 0 BS EN 60601-2-3 AMD1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT - PROPOSED HORIZONTAL STANDARD
16/30316718 DC : 0 BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
BS EN 62366-1:2015 Medical devices Application of usability engineering to medical devices
I.S. EN 60613:2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
CEI EN 60645-7 : 2013 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY BRAINSTEM RESPONSE
UNE-EN ISO 23500:2016 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
08/30159296 DC : DRAFT APR 2008 BS EN ISO 15225 - NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
BS ISO 7197:1997 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
09/30178059 DC : 0 BS ISO 7176-9 - WHEELCHAIRS - PART 9: CLIMATIC TESTS FOR ELECTRIC WHEELCHAIRS
04/30081057 DC : DRAFT AUG 2004 EN ISO 10535 - HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
08/30174059 DC : DRAFT JUNE 2008 BS ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL VALIDATION OF AUTOMATED MEASUREMENT TYPE
DIN EN 1865-5:2012-09 Patient handling equipment used in road ambulances - Part 5: Stretcher support
14/30296597 DC : 0 BS EN 60601-2-54/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
04/19984413 DC : DRAFT MARCH 2004 BS ISO 14835-1 - MECHANICAL VIBRATION AND SHOCK - COLD PROVOCATION TESTS FOR THE ASSESSMENT OF PERIPHERAL VASCULAR FUNCTION - PART 1 - MEASUREMENT AND EVALUATION OF FINGER SKIN TEMPERATURE
CSA Z9360.1 : 2007 : R2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - HEAT AND MOISTURE EXCHANGERS (HMES) FOR HUMIDIFYING RESPIRED GASES IN HUMANS - PART 1: HMES FOR USE WITH MINIMUM TIDAL VOLUMES OF 250 ML
IEC 60335-2-69 REDLINE : 5.0 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-69: PARTICULAR REQUIREMENTS FOR WET AND DRY VACUUM CLEANERS, INCLUDING POWER BRUSH, FOR COMMERCIAL USE
I.S. EN ISO 5367:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
16/30312315 DC : 0 BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
NF EN 60601-1-10 : 2008 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
I.S. EN ISO 11073-10425:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10425: DEVICE SPECIALIZATION - CONTINUOUS GLUCOSE MONITOR (CGM) (ISO 11073-10425:2016)
EN ISO 11073-10427:2018 Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018)
CAN/CSA-Z10524-4:12 (R2017) Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations)
06/30122245 DC : 0 EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
NF EN 60601-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
EN ISO 10650:2015 Dentistry - Powered polymerization activators (ISO 10650:2015)
IEC TR 60601-4-4:2017 Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
CSA Z18779 : 2008 MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
BS IEC 60825-8:1999 Safety of laser products Guidelines for the safe use of medical laser equipment
CSA ISO 5367 : 2014 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
99/714207 DC : DRAFT SEP 1999 ISO/DIS 13091-1 - MECHANICAL VIBRATION - VIBROTACTILE PERCEPTION THRESHOLD FOR THE ASSESSMENT OF NERVE DYSFUNCTION - PART 1: TEST METHODS FOR MEASUREMENT AT THE FINGERTIPS
BS EN 60601-2-9:1997 Medical electrical equipment. Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
CSA Z18777 : 2008 : R2013 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
CAN/CSA-Z9360-1-07 (R2017) Anaesthetic and Respiratory Equipment - Heat and Moisture Exchangers (HMEs) for Humidifying Respired Gases in Humans - Part 1: HMEs for Use with Minimum Tidal Volumes of 250 ml (Adopted ISO 9360-1:2000, first edition, 2000-03-15, with Canadian deviations)
AAMI ISO 14708-4:2008(R2011) IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
IEC 80601-2-30 REDLINE : 2ED 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
05/30125283 DC : DRAFT MAY 2005 EN ISO 12865 - OPHTHALMIC INSTRUMENTS - RETINOSCOPES
UNE-EN ISO 81060-2:2014 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA Z10651-5 : 2008 : R2018 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
CEI EN 60613 : 2010 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
DIN EN ISO 80601-2-69:2014-12 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
DIN EN ISO 5367 E : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
CSA Z10651.2 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
ISO 11195:2018 Gas mixers for medical use — Stand-alone gas mixers
DIN EN ISO 23328-2 E : 2009 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
CSA Z21647 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
I.S. EN ISO 11073-30400:2012 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET (ISO 11073-30400:2012)
ISO 5358:1992 Anaesthetic machines for use with humans
UNE-EN ISO 10079-1:2016 Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
CEI EN 61267 : 2006 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS
CSA CEI/IEC 1289.2 : 1998 HIGH-FREQUENCY SURGICAL EQUIPMENT - PART 2: MAINTENANCE
CSA C22.2 No. 60601-1-10 : 2009 : INC : AMD 1 : 2014 : R201400 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
IEEE 11073-10425-2014 Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)
UNE-EN ISO 22665:2013 Ophthalmic optics and instruments - Instruments to measure axial distances in the eye (ISO 22665:2012)
UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
I.S. EN 62467-1:2015 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
I.S. EN 60601-2-30:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
EN 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
CEI EN 60601-2-26 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-26: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROENCEPHALOGRAPHS
IEEE/ANSI C63.12-2015 REDLINE American National Standard Recommended Practice for Electromagnetic Compatibility Limits and Test Levels
I.S. EN 60627:2015 DIAGNOSTIC X-RAY IMAGING EQUIPMENT - CHARACTERISTICS OF GENERAL PURPOSE AND MAMMOGRAPHIC ANTI-SCATTER GRIDS
I.S. EN 60601-2-37:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
I.S. EN ISO 80601-2-55:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
IEEE 11073-10418-2011 IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor
NF EN 61331-3 : MAY 2015 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION - PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
I.S. EN 60522:1999 DETERMINATION OF THE PERMANENT FILTRATION OF X-RAY TUBE ASSEMBLIES
NF EN 60601 2-3 : 2015 AMD 1 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT
BS IEC 82304-1 : 2016 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
I.S. EN ISO 81060-2:2014 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013)
AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS