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ISO 14971:2007

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical devices Application of risk management to medical devices
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

12-12-2019

Language(s)

English, French, Russian

Published date

28-02-2007

Preview

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

DevelopmentNote
Supersedes ISO 14971-1. (12/2000) DRAFT ISO/DIS 14971 is also available for this standard. (06/2018)
DocumentType
Standard
Pages
82
ProductNote
THIS STANDARD ALSO HAVE CORRECT VERSION FOR ENGLISH & FRENCH FOR THE YEAR 2007
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

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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)
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
ONORM EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
DIN EN ISO 7199:2015-06 (Draft) CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ISO 19227:2018 Implants for surgery — Cleanliness of orthopedic implants — General requirements
CSA C22.2 No. 61010.2.040 : 2016 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
CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
15/30321242 DC : 0 BS EN ISO 12870 - OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS
ANSI/AAMI/ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
BS ISO 13779-6:2015 Implants for surgery. Hydroxyapatite Powders
I.S. EN ISO 12870:2014 OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2016)
I.S. EN 62570:2015 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
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)
AAMI/ISO TIR17665-3:2014(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
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)
PREN ISO 11137-2 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
BS EN ISO 11073-10424:2016 Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE)
I.S. EN ISO 26782:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
BS EN ISO 7396-1:2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
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)
GOST ISO 14698-1 : 2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
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)
CEI EN 61326-2-6 : 2014 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
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
BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
I.S. EN ISO 10524-4:2008 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS
ANSI/AAMI/ISO 15674:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ANSI/AAMI/ISO 80369-20:2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS
DIN EN ISO 14607:2009-08 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
BS EN ISO 80601-2-12:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators
I.S. EN 15546-1:2008 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 10993-17 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
ISO 7176-16:2012 Wheelchairs Part 16: Resistance to ignition of postural support devices
BS EN 60601-1-6 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 13179-1:2014 Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements
CSA C22.2 No. 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
UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
CSA ISO TR 13154 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH
UNI EN ISO 18113-4 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
UNI CEI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 10079-1:2015 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
AAMI TIR38 : 2015 MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE
UNE-EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
AAMI CN6 : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
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 11073-10427:2018 Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices
AAMI ISO TIR 10974 : 2012 ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
I.S. EN ISO 10993-16:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010)
BIS IS/ISO 11979-8 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
ONORM EN ISO 10524-1 : 2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
UNI EN 12183 : 2014 MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS
I.S. EN 80601-2-35:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
UNE-EN ISO 15621:2018 Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
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)
ISO 14607:2007 Non-active surgical implants Mammary implants Particular requirements
NF EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
UNI CEI EN 980 : 2009 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ONORM EN ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
ASTM E 2898 : 2014 : REDLINE Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
I.S. EN 1865-2:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
I.S. EN ISO 15194:2009 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 :2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
ISO 80601-2-55:2018 Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
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
AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
DIN EN ISO 11979-5:2010-11 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
BS EN ISO 80601-2-13:2012+A2:2019 Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
DIN EN ISO 10993-17 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
DIN EN ISO 14698-1 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
DIN EN ISO 9680 E : 2015 DENTISTRY - OPERATING LIGHTS (ISO 9680:2014)
DIN EN ISO 21969:2010-04 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 1642:2012-06 Dentistry - Medical devices for dentistry - Dental implants
DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
DIN EN ISO 11137-3:2015-08 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
BS EN ISO 10993-1 : 2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009)
BS EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices
BS EN ISO 10993-12:2012 Biological evaluation of medical devices Sample preparation and reference materials
BS EN ISO 11979-9 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
ISO 23907:2012 Sharps injury protection Requirements and test methods Sharps containers
ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
I.S. EN ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
ISO 7494-2:2015 Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems
UNE-EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 455-3:2015 Medical gloves for single use Requirements and testing for biological evaluation
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 EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
ISO 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
UNE-EN ISO 16672:2016 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
BS EN ISO 14630:2012 Non-active surgical implants. General requirements
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
BS EN ISO 16201:2006 Technical aids for disabled persons. Environmental control systems for daily living
ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
I.S. EN ISO 11608-1:2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
I.S. EN ISO 10535:2006 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 10524-2:2006-07 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
UNI EN ISO 9170-1 : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
EN ISO 19054:2006/A1:2016 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005/AMD 1:2016)
DIN EN 14931:2006-08 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
DIN EN ISO 14155-2:2003-09 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
EN ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
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
DIN EN ISO 14155-1:2003-09 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
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 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 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
DIN EN ISO 14155-1:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
DIN EN 15908:2011-01 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES
EN ISO 9680:2014 Dentistry - Operating lights (ISO 9680:2014)
EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
DIN EN ISO 14698-1:2004-04 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
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)
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 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
NF EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
UNI EN ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
I.S. EN ISO 16201:2006 TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING
ONORM EN ISO 7494-2 : 2015 DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015)
VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
ONORM EN 12184 : 2014 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
ONORM EN 12183 : 2015 MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS
VDI 5700 Blatt 1:2015-04 Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
ONORM EN ISO 7439 : 2015 COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
ONORM EN ISO 11608-5 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
ONORM EN ISO 11608-1 : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
BS ISO 19611:2017 Traditional Chinese medicine. Air extraction cupping device
ANSI/AAMI/ ISO 11137-2:2013(R2019) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
BS EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
ONORM EN ISO 11979-5 : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
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
CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
ONORM EN ISO 10993-1 : 2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
CSA Z10524-2 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
ISO/TR 20520:2018 Traditional Chinese medicine Infection control for acupuncture treatment
16/30314880 DC : 0 BS EN ISO 9170-1 - TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
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
AAMI ISO 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
09/30173644 DC : 0 BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
I.S. EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
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
17/30359001 DC : 0 BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
BS EN ISO 26722:2015 Water treatment equipment for haemodialysis applications and related therapies
BS ISO 15001 : 2003 AMD 15145 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
I.S. EN 82304-1:2017 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
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
ISO/IEEE 11073-10425:2016 Health informatics Personal health device communication Part 10425: Device specialization Continuous glucose monitor (CGM)
UNE-EN ISO 11608-5:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
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NF EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
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
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
I.S. EN ISO 17665-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
08/30154605 DC : DRAFT APR 2008 BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
BS ISO 8600-1:2015 Endoscopes. Medical endoscopes and endotherapy devices General requirements
NF EN ISO 80369-7 : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
UNE-EN ISO 13504:2013 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
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
DIN EN ISO 11608-5:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
I.S. EN 1865-3:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
16/30302523 DC : 0 BS EN ISO 15621 - ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
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
UNI EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
PD ISO/TS 17822-1:2014 <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
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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)
BS EN ISO 23907:2012 Sharps injury protection. Requirements and test methods. Sharps containers
08/30179586 DC : DRAFT MAR 2008 BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
BS ISO 10651-5:2006 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators
AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses Clinical investigations
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
DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 80601-2-72:2016-04 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)
AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
10/30216029 DC : 0 BS EN 61326-2-6 - ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
BS ISO 16840-6:2015 Wheelchair seating Simulated use and determination of the changes in properties of seat cushions
I.S. EN ISO 23907:2012 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS (ISO 23907:2012)
BS EN ISO 10524-1:2006 Pressure regulators for use with medical gases Pressure regulators and pressure regulators with flow-metering devices
12/30269739 DC : 0 IEC 61010-2-101 ED 2 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR LABORATORY EQUIPMENT FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
UNE-EN ISO 80369-1:2011 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
DD ISO/TS 25238:2007 Health informatics. Classification of safety risks from health software
EN ISO 80369-6 : 2016 COR 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)
I.S. EN ISO 13940:2016 HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE (ISO 13940:2015)
06/30146526 DC : 0 BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
DIN EN ISO 15621:2016-06 (Draft) ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017)
ISO 12870:2016 Ophthalmic optics Spectacle frames Requirements and test methods
13/30240399 DC : 0 ISO/IEC GUIDE 51 - SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS
06/30146522 DC : 0 BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
BS ISO 15378 : 2006 AMD 17315 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
PD ISO/TR 13014:2012 Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
BS EN ISO 13408-7:2015 Aseptic processing of health care products Alternative processes for medical devices and combination products
15/30321715 DC : 0 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
13/30268585 DC : 0 BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT
DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
04/30057165 DC : 0 BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
I.S. EN ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
14/30295067 DC : 0 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
17/30344601 DC : 0 BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
08/30179589 DC : DRAFT MAR 2008 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
BS ISO 11658:2012 Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion 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
DIN EN ISO 23907:2013-01 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS (ISO 23907:2012)
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
BS EN ISO 7199:2017 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS ISO 13179-1:2014 Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants General requirements
06/30145887 DC : DRAFT FEB 2006 EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
DIN EN ISO 15002:2008-11 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
13/30281504 DC : 0 BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
11/30193150 DC : 0 BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
15/30321712 DC : 0 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
14/30267655 DC : 0 BS ISO 13779-6 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 6: POWDERS
11/30212235 DC : 0 BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
BS EN ISO 13940:2016 Health informatics. System of concepts to support continuity of care
15/30321957 DC : 0 BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS)
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
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
DIN EN ISO 25539-3:2012-03 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
06/30146515 DC : 0 BS ISO 18113-2 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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
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)
12/30212355 DC : 0 BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA SPRAYED COATINGS OF UNALLOYED TITANIUM - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 13958:2016-03 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
AAMI ISO 10993-16 : 2010 : R2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
BS EN ISO 18113-4:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
04/30066665 DC : DRAFT MARCH 2004 BS ISO 13408-6 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6 - ISOLATOR SYSTEMS
PD ISO/TR 13154:2017 Medical electrical equipment. Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
10/30195946 DC : DRAFT DEC 2010 BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
14/30294895 DC : 0 BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
09/30195717 DC : 0 BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
BS EN 45502-2-3:2010 Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems
04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30270468 DC : 0 BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
03/103026 DC : DRAFT JAN 2003 BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
CSA Z1500:2012 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
TR 102 415 : 1.1.1 HUMAN FACTORS (HF); TELECARE SERVICES; ISSUES AND RECOMMENDATIONS FOR USER ASPECTS
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
AAMI ISO 5840 : 2005 : R2010 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
CEI EN 80369-5 : 1ED 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
BS ISO 15674:2009 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
CSA Z11137-2 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
BS ISO/IEC 16085:2006 Systems and software engineering. Life cycle processes. Risk management
DIN EN ISO 11979-7:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
08/30179592 DC : DRAFT MAR 2008 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
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
DIN EN ISO 14155:2012-01 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
16/30302520 DC : 0 BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
BS EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications
AAMI ISO 5840 :2005 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
PD ISO/TR 16142:2006 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
S.R. CEN/CLC/TR 14060:2014 MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI)
CSA Z10651-5 : 2008 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
17/30311331 DC : 0 BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
CSA ISO/IEC 16085 : 2007 : R2012 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT
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)
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA C22.2 No. 60601.1.8 : 2008 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
DIN EN ISO 18113-2:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
ANSI/AAMI/ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
CSA Z21647 : 2007 : R2012 : FR MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
BS EN 61010-1:2010+A1:2019 Safety requirements for electrical equipment for measurement, control, and laboratory use General requirements
AAMI/ISO TIR15499:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
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)
BS EN ISO 10555-1 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 5361:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
I.S. EN 61010-2-101:2017 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
BS EN 61810-1:2015 Electromechanical elementary relays General and safety requirements
S.R. CWA 16697:2013 CAR-ADAPTATIONS FOR DISABLED DRIVERS - REQUIREMENTS, TEST METHODS AND BEST PRACTISE GUIDELINES
ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
UNE-EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
I.S. EN 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
AAMI ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
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)
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 62353:2014 MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
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)
AAMI/ISO TIR 80002-2:2017 MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS
AAMI BE83 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
BS EN ISO 13017 : 2012 DENTISTRY - MAGNETIC ATTACHMENTS
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
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
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)
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)
AAMI TIR45 : 2012 GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
CEI UNI EN ISO 80369-1 : 2011 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
CEI UNI EN 1041 : 2014 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
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)
AAMI ISO 14155 : 2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
CSA ISO 11712:14 (R2019) Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
BS EN ISO 5359 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
BS EN ISO 14607:2009 Non-active surgical implants. Mammary implants. Particular requirements
UNI EN ISO 14155 : 2012 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
CSA C22.2 No. 80601-2-69 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
UNI EN ISO 14607 : 2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
CSA ISO 10079-2 : 2014 MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
BS ISO 7176-16:2012 Wheelchairs Resistance to ignition of postural support devices
CEI UNI EN/ISO 80369-7 : 1ED 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
CSA Z17510.2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
BS EN ISO 5367:2014 Anaesthetic and respiratory equipment. Breathing sets and connectors
DIN EN 12183:2014-06 Manual wheelchairs - Requirements and test methods
UNE-EN ISO 5367:2015 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
ONORM EN ISO 10524-2 : 2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
AAMI ISO 15223-2 : 2010 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
ISO 16840-6:2015 Wheelchair seating — Part 6: Simulated use and determination of the changes in properties of seat cushions
CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
BS EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications
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
ISO 18666:2015 Traditional Chinese medicine General requirements of moxibustion devices
CSA C22.2 No. 80601-2-35 : 2012 : INC : COR 1 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
EN ISO 11979-10:2018 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
UNE-EN ISO 13958:2016 Concentrates for haemodialysis and related therapies (ISO 13958:2014)
NF EN 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
I.S. EN 556-1:2002 STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES
UNI EN ISO 12870 : 2015 OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS
AAMI/IEC TIR80001-2-5:2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
ANSI/AAMI/IEC TIR62354:2015 GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
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
DIN EN ISO 22442-2:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
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
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials
DIN EN 556-2:2015-11 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
DIN EN ISO 23747:2015-12 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
DIN EN 12182:2012-07 Assistive products for persons with disability - General requirements and test methods
DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
DIN EN ISO 17510-2:2009-07 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
DIN EN ISO 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
DIN EN 12184:2014-06 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
DIN EN ISO 7494-2:2015-08 Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
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 4074:2016-05 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
DIN EN ISO 11979-9:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 11979-8 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
DIN EN ISO 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
DIN EN ISO 11979-7 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 11979-9 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
DIN EN ISO 11979-6 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
BS EN ISO 10535:2006 Hoists for the transfer of disabled persons. Requirements and test methods
ISO/IEEE 11073-10418:2014 Health informatics Personal health device communication Part 10418: Device specialization International Normalized Ratio (INR) monitor
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
UNE-EN ISO 21969:2010 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
UNE-EN 14065:2017 Textiles - Laundry processed textiles - Biocontamination control system
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)
BS EN ISO 7494-2:2015 Dentistry. Dental units Air, water, suction and wastewater systems
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests
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 10079-2:2014 Medical suction equipment Manually powered suction equipment
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 ISO 11979-8:2017 Ophthalmic implants. Intraocular lenses Fundamental requirements
BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Application of risk management
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 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO/IEEE 11073-10441:2015 Health informatics Personal health device communication Part 10441: Device specialization Cardiovascular fitness and activity monitor
ISO 11608-7:2016 Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
DIN EN ISO 9680:2015-02 Dentistry - Operating lights (ISO 9680:2014)
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ONORM EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
I.S. EN 12184:2014 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
EN ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
I.S. EN ISO 22794:2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
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 14065:2016 TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM
I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
I.S. EN ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
I.S. EN ISO 10079-2:2014 MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)
I.S. EN ISO 9626:2016 STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 17510-2:2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
UNI EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
I.S. EN 12182:2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7439:2015 COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
I.S. EN ISO 11137-2:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013)
I.S. EN ISO 15001:2011 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN (ISO 15001:2010)
I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
I.S. EN ISO 22442-2:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015)
I.S. EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
I.S. EN 1642:2011 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
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 11137-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
I.S. EN ISO 10993-17:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
I.S. EN ISO 4074:2015 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
ONORM EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
I.S. EN ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
DIN EN ISO 11137-2:2015-11 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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 7494-2:2015 DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015)
EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
I.S. EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
I.S. EN 1641:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. 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
I.S. EN ISO 11979-8:2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
I.S. EN ISO 10451:2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
I.S. EN ISO 10993-12:2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
I.S. EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
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 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
DIN EN 1789:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
I.S. EN ISO 21969:2009 HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS
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 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
I.S. EN ISO 11979-6:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
I.S. EN ISO 14698-1:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
I.S. EN ISO 10993-13:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)
I.S. EN ISO 16672:2015 OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
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 1422:1997-11 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN 820-12:2014-06 STANDARDIZATION - PART 12: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:2014)
UNI EN ISO 11979-6 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING
UNI EN 1642 : 2012 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
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
VDI 4007:2012-06 Reliability goals - Determination, check, review, certificate
VDI 4003:2007-03 Reliability management
NEMA/MITA XR 30:2016 Quality Control Tools for Digital Projection Radiography
NEMA/MITA 1:2015 Good Refurbishment Practices for Medical Imaging Equipment
OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
UNE-EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
UNI EN ISO 9170-2 : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
BS ISO 15198:2004 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
I.S. EN 12183:2014 MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS
CSA Z10524-1 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
UNI EN ISO 81060-1 : 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
CSA Z23747 : 2008 : R2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
16/30339831 DC : 0 PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE
BS ISO 17218:2014 Sterile acupuncture needles for single use
CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
13/30260084 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
15/30281262 DC : 0 BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
DIN EN ISO 15621 E : 2017 ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017)
PD ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
09/30197590 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
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
10/30196945 DC : 0 BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
ANSI/AAMI/IEC 80001-1:2010 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN ISO 7199 E : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
07/30151731 DC : 0 BS IEC 80601-2-35 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
08/30116059 DC : DRAFT AUG 2008 ISO 14155 REV - CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
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
14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
DIN EN 1865-2:2015-05 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
PD ISO/TR 16197:2014 Nanotechnologies. Compilation and description of toxicological screening methods for manufactured nanomaterials
ISO 29942:2011 Prophylactic dams — Requirements and test methods
BS ISO 15223-2:2010 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation
ANSI/AAMI/IEC TIR62348:2012 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
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
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS ISO 15675:2009 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
AAMI TIR36 : 2007 VALIDATION OF SOFTWARE FOR REGULATED PROCESSES
16/30346829 DC : 0 BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
BS EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities
BS ISO 25841:2017 Female condoms. Requirements and test methods
17/30321196 DC : 0 BS EN ISO 23500-2 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 2: WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 80601-2-72 E : 2016 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)
I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
17/30321202 DC : DRAFT MAY 2017 BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN ISO 7197:2009 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
BS EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications
11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
UNE-EN 1865-1:2011 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
DIN EN ISO 13408-7 E : 2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
BS EN 82304-1:2017 Health Software General requirements for product safety
I.S. EN 61326-2-6:2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV))
AAMI ISO 10651-5 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
UNI EN ISO 11073-30400 : 2013 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET
ISO 20696:2018 Sterile urethral catheters for single use
BS EN ISO 81060-1:2012 Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type
17/30343686 DC : 0 BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
DIN EN ISO 80369-20 E : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015)
13/30270477 DC : 0 BS ISO 26722 - WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
UNI EN ISO 80601-2-69 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
ISO 16571:2014 Systems for evacuation of plume generated by medical devices
BS EN 15908:2010 Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
AAMI ISO 10993-1:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
12/30251858 DC : 0 BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
14/30290166 DC : 0 BS ISO 16142-1 - 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
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
BS ISO 23409:2011 Male condoms. Requirements and test methods for condoms made from synthetic materials
DD CEN/TS 14507-2:2003 Inhalational nitric oxide systems Supply systems
UNE-EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
13/30280551 DC : 0 BS ISO 16840-6 - WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES - SEAT CUSHIONS
09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods Automated functions
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)
BS ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
BS ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of particulate matter
14/30296035 DC : 0 BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
09/30176675 DC : 0 BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
BS EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications General requirements
PD ISO/TR 80002-2:2017 Medical device software Validation of software for medical device quality systems
AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
NF EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
10/30208977 DC : 0 BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
AAMI ISO 81060-1:2007(R2013) NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
BS EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems Terminal units for anaesthetic gas scavenging systems
BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses General requirements
BS EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
UNE-EN 16372:2015 Aesthetic surgery services
ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
I.S. EN ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
17/30336158 DC : 0 BS EN ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA
BS EN ISO 15621:2017 Absorbent incontinence aids for urine and/or faeces. General guidelines on evaluation
AAMI IEC 62366 : 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
04/30099768 DC : DRAFT DEC 2004 PREN ISO 8835-3 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: ANAESTHETIC GAS SCAVENGING SYSTEMS - TRANSFER AND RECEIVING SYSTEMS
CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA IEC 62366 : 2014 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
UNI EN ISO 20072 : 2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
UNE-EN ISO 10079-1:2016 Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
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
BIS IS/ISO 10524-2 : 2005 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
14/30257644 DC : 0 BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
CSA C22.2 No. 61010.1 :2012 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques
BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
CSA Z10651.6 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
I.S. CEN TS 15260:2006 HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
UNE-EN 80369-5:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
AAMI/IEC TIR80002-3:2016 MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304)
CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNE-EN ISO 5840-1:2016 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
CSA ISO 14937 : 2011 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO/TS 20993:2006 Biological evaluation of medical devices Guidance on a risk-management process
AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
CSA Z11137-2 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
DIN EN ISO 7198 E : 2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
CSA ISO/IEC 16085 : 2007 : R2017 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT
CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
UNI EN ISO 11608-5 : 2013 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
I.S. EN 80369-5:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
IEC TS 62844:2016 Guidelines for quality and risk assessment for nano-enabled electrotechnical products
IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
EN ISO 16671:2015/A1:2017 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
BS EN 1865-2 : 2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
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)
PREN ISO 80369-1 : DRAFT 2009 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
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
AAMI ISO 25539-3 : 2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
CAN/CSA-ISO 11137-3:17 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control (Adopted ISO 11137-3:2017, second edition, 2017-06)
I.S. EN ISO 20608:2018 DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018)
I.S. EN ISO 15621:2017 ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017)
BS ISO/IEC 15026-3:2015 Systems and software engineering. Systems and software assurance System integrity levels
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 ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
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)
I.S. EN ISO 13408-7:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
BS EN ISO 18369-2:2017 Ophthalmic optics. Contact lenses Tolerances
ANSI/AAMI/ISO 11658:2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
AAMI ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ANSI/AAMI/ISO TIR10993-20:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
ANSI/AAMI ISO 17665-1:2006(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
EN 13060:2014 Small steam sterilizers
AAMI TIR48 : 2015 QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
ANSI/AAMI/ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI ISO 5840-1 : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
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 16372:2014 AESTHETIC SURGERY SERVICES
EN 12183:2009 Manual wheelchairs - Requirements and test methods
AAMI ISO 14708-5 : 2010 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
CSA C22.2 No. 80601-2-35 : 2012(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
BS EN 62366 : 2008 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNI EN ISO 5361 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
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)
ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
I.S. EN ISO 13504:2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
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
AAMI ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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)
BS EN ISO 10993-16:2017 Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
DIN EN ISO 12870:2015-07 (Draft) OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012)
ISO/PAS 18761:2013 Use and handling of medical devices covered by the scope of ISO/TC 84 Risk assessment on mucocutaneous blood exposure
I.S. EN ISO 9170-2:2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
EN ISO 10555-1:2013/A1:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
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)
ISO 16671:2015 Ophthalmic implants — Irrigating solutions for ophthalmic surgery
NF EN ISO 10524-2 : 2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
BS EN ISO 12870:2014 Ophthalmic optics. Spectacle frames. Requirements and test methods
DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
ISO 14708-6:2010 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
CSA ISO 10079-3 : 2014 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
CSA Z7396.2 : 2002 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
UNI EN ISO 10524-3 : 2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
ISO/TR 16197:2014 Nanotechnologies Compilation and description of toxicological screening methods for manufactured nanomaterials
EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
PREN 12184 : DRAFT 2011 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 25539-3:2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011)
CEN/CLC/TR 14060:2014 Medical device traceability enabled by unique device identification (UDI)
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 25841:2017 Female condoms — Requirements and test methods
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)
UNI EN ISO 25539-3 : 2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
PREN ISO 11979-6 : DRAFT 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)
NF EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CAN/CSA-C22.2 NO. 61010-1-12 (R2017) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (Tri-national standard, with UL 61010-1 and ANSI/ISA-61010-1 (82.02.01)
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
ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO/TR 15499:2016 Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
ISO 16840-10:2014 Wheelchairs Resistance to ignition of non-integrated seat and back support cushions Part 10: Requirements and test methods
I.S. EN ISO 7197:2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
ISO/TS 17665-3:2013 Sterilization of health care products Moist heat Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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)
ISO 7176-28:2012 Wheelchairs — Part 28: Requirements and test methods for stair-climbing devices
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)
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
BS EN ISO 10524-2:2006 Pressure regulators for use with medical gases Manifold and line pressure regulators
EN ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
I.S. EN ISO 16671:2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
IEC TR 62653:2012 Guideline for safe operation of medical equipment used for haemodialysis treatments
ISO/IEC 16085:2006 Systems and software engineering Life cycle processes Risk management
I.S. EN ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
NF EN ISO 11197 : 2016 MEDICAL SUPPLY UNITS
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 ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
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
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
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 13060:2015-03 SMALL STEAM STERILIZERS
DIN EN ISO 7439:2015-08 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
DIN EN 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
DIN EN ISO 10993-1:2010-04 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)
DIN EN ISO 15001:2012-06 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
DIN EN ISO 11979-5 E : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11608-1:2015-04 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
DIN EN ISO 11979-6:2015-02 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
DIN EN ISO 19054:2006-09 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005 + AMD1:2016)
ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects Clinical investigation plans
UNE-EN ISO 9626:2017 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
BS EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
BS EN ISO 10993-18:2009 Biological evaluation of medical devices Chemical characterization of materials
BS EN ISO 23747:2015 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
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
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
ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
UNE-EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
BS EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
UNE-EN ISO 26782:2010 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
IEC 61810-1:2015 Electromechanical elementary relays - Part 1: General and safety requirements
BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
I.S. EN ISO 10993-18:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005)
EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
ONORM EN ISO 9170-1 : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
UNE-EN 61010-1:2011 Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 1: General requirements
I.S. EN 1789:2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
UNE-EN 60601-1:2008 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
EN ISO 11979-9:2006/A1:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
ISA 61010-1 : 2008 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
EN ISO 80601-2-69:2014 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 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
EN ISO 13017:2012/A1:2015 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012/AMD 1:2015)
I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
I.S. EN ISO 11979-5:2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
EN ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
I.S. EN ISO 15883-1:2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
EN ISO 7494-2:2015 Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
EN ISO 11608-7:2017 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
UNI EN ISO 5840 : 2009 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
UNI EN 1641 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
ONORM EN ISO 15798 : 2013 AMD 1 2018 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
UNI EN ISO 21647 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN ISO 10451 : 2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
UNI CEN ISO/TS 22367 : 2010 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN ISO 16201 : 2007 TECHNICAL AIDS FOR DISABLED PERSONS - ENVIRONMENTAL CONTROL SYSTEMS FOR DAILY LIVING
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
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 12184 : 2014 ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
UNI EN ISO 15883-1 : 2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
UNI EN ISO 17510-2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
UNI EN ISO 7396-2 : 2007 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
UNI EN ISO 10993-13 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
UNI EN ISO 11979-9 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
UNI EN ISO 10079-3 : 2014 MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
ONORM EN ISO 10079-2 : 2014 MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)
UNI EN ISO 21969 : 2010 HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GAS SYSTEMS
BS EN ISO 7405 : 2008 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
UNI EN ISO 14155-1 : 2009 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
UNI EN ISO 14937 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 10079-2 : 2014 MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI CEI EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements
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
ONORM 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)
UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN 12182 : 2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
UNI EN 1422 : 2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNI EN ISO 10993-17 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
UNI EN ISO 15001 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
UNE-EN ISO 5361:2017 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
UNI CEI EN 15546-1 : 2009 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
UNE-EN ISO 12870:2014 Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
BS EN ISO 18113-2:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
CSA Z10524-3 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
02/560598 DC : DRAFT FEB 2002 ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES
I.S. EN ISO 13958:2015 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
PD ISO/PAS 18761:2013 Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
13/30254047 DC : 0 BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
UNI EN ISO 10993-1 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
CSA Z10524-2 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
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)
UNI EN ISO 11979-7 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
DIN EN ISO 20857 E : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
ISO/TR 16196:2016 Nanotechnologies Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials
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
15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
17/30356316 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
UNI EN 15908 : 2010 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES
ONORM EN ISO 11979-7 : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
14/30277509 DC : 0 BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS
15/30325469 DC : 0 BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
IEEE 11073-10419-2015 IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump
PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
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
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
07/30147554 DC : DRAFT SEP 2007 BS ISO 16628 - TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
08/30192448 DC : DRAFT DEC 2008 BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
UNI CEN/TS 15277 : 2007 NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS
AAMI/IEC TIR80002-1:2009 MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
05/30128342 DC : DRAFT AUG 2005 ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
09/30186527 DC : 0 BS EN ISO 23908-1 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING
PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
DIN 820-120:2012-09 STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999)
13/30250915 DC : 0 BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
DIN EN ISO 15194:2009-10 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
09/30193293 DC : DRAFT MAR 2009 BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS
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
ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
I.S. EN ISO 21647:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
BS ISO 8009:2014 Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests
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UNI CEI EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
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16/30280931 DC : DRAFT APR 2016 BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
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03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
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12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
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UNI EN ISO 8835-3 : 2010 INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS
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10/30208681 DC : DRAFT SEP 2010 BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
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AAMI ISO 10993-13:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
NFS 99 171 : 2006 MAINTENANCE OF MEDICAL DEVICES - MODEL AND DEFINITION FOR ESTABLISHMENT AND MANAGEMENT OF THE MEDICAL DEVICE SECURITY, QUALITY AND MAINTENANCE REGISTER (RSQM)
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AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
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AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
CSA Z9170.1 : 2011 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES, VACUUM, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
AAMI ISO 14708-4 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
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AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
DD CEN/TS 15260:2006 Health informatics. Classification of safety risks from health informatics products
UNI EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
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
CSA Z21647:2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
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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
UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
NF EN ISO 25539-3 : 2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
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PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
AAMI ISO 10993-16:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
ANSI Z80.11 : 2012 : R2017 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
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ISO 80601-2-67:2014 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
CSA C22.2 No. 80601-2-55 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic compounds (VOCs)
CSA ISO 11137-2 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
S.R. CEN/TR 16386:2013 DENTISTRY - GUIDELINES FOR HANDLING METHACRYLATE-BASED MATERIALS IN THE DENTAL LABORATORY
I.S. EN ISO 13017:2012 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012)
IEEE 730-2014 REDLINE IEEE Standard for Software Quality Assurance Processes
I.S. EN ISO 7886-1:1998 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
I.S. EN ISO 18113-4:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI ISO 27185 : 2012 CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
IEEE/ISO/IEC 16085-2006 ISO/IEC/IEEE International Standard - Systems and Software Engineering - Life Cycle Processes - Risk Management
ISO/TS 20405:2018 Health informatics Framework of event data and reporting definitions for the safety of health software
I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ANSI/AAMI/ISO 80369-6:2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
CAN/CSA-C22.2 NO. 80601-2-67:17 Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations)
AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
ANSI/AAMI/ISO 14708-3:2017 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
ANSI/AAMI/ISO 13408-7:2012(R2018) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
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)
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
I.S. EN ISO 15002:2008 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
ISO/TR 13014:2012 Nanotechnologies Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
I.S. EN ISO 26722:2015 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014)
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 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)
I.S. EN 1865-1:2010 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
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)
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
I.S. EN 15908:2010 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES
UNI EN ISO 23907 : 2013 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS
ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
EN ISO 11197:2016 Medical supply units (ISO 11197:2016)
ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions
ISO 17218:2014 Sterile acupuncture needles for single use
ISO 10524-1:2018 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 14708-4:2008 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
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 13485 - PRACTICAL GUIDE : 2016 ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
UNE-EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
DIN EN ISO 9170-1 E : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
BS EN 12183:2014 Manual wheelchairs. Requirements and test methods
I.S. EN ISO 7405:2009 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
UNI EN ISO 11135 : 2014 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
IEEE 11073-10427-2016 IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices
UNE-EN 12183:2014 Manual wheelchairs - 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)
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
DIN EN ISO 7405:2013-12 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013)
I.S. EN ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
UNE-EN 13060:2015 Small steam sterilizers
AAMI ISO 26782 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
UNE-EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
ISO 13779-6:2015 Implants for surgery Hydroxyapatite Part 6: Powders
UNE-EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
EN ISO 11979-7:2018 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
EN ISO 13485:2016/AC:2018 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
UNI EN ISO 7405 : 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ISO 15674:2016 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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 27185:2012 Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
DIN EN ISO 9170-1:2016-09 (Draft) TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
EN ISO 20608:2018 Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
ISO 10524-2:2018 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
BS EN ISO 11197:2009 Medical supply units
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
BS EN ISO 16671 : 2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
DIN EN ISO 80369-1:2015-09 (Draft) SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 18835:2015 Inhalational anaesthesia systems Draw-over anaesthetic systems
ISO 8009:2014 Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
ISO/TS 18339:2015 Endotherapy devices — Eyepiece cap and light guide connector
ISO 18369-2:2017 Ophthalmic optics — Contact lenses — Part 2: Tolerances
IEC 62820-3-2:2018 Building intercom systems - Part 3-2: Application guidelines - Advanced security building intercom systems (ASBIS)
ISO 10651-5:2006 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators
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 ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
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 11608-1 E : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 10079-1:2016-05 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 16201:2006-12 Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006)
DIN EN ISO 10079-2:2014-09 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
BS EN ISO 8185:2007 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13504:2012 Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
BS EN ISO 11979-5:2006 Ophthalmic implants. Intraocular lenses Biocompatibility
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
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)
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
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 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
BS EN ISO 19054 : 2006 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005)
BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects General requirements
PD IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
BS EN ISO 10079-3:2014 Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source
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
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
BS EN ISO 14937:2009 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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
ONORM EN ISO 15002 : 2008 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
BS EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
UNE-EN ISO 4074:2016 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
UNE-EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
UNE-EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
BS EN ISO 11979-6:2014 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing
BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 11979-6:2014 Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing
UNE-EN ISO 10993-12:2013 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
UNE-EN ISO 11979-7:2015 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
BS EN 1789 : 2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 11979-8:2017 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
ISO 15621:2017 Absorbent incontinence aids for urine and/or faeces — General guidelines on evaluation
ISO 16672:2015 Ophthalmic implants Ocular endotamponades
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
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
UNE-EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
BS EN 13060 : 2014 SMALL STEAM STERILIZERS
UNE-EN 1789:2007 Medical vehicles and their equipment - Road ambulances
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
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 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
I.S. EN ISO 10993-1:2009+AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009)
BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
I.S. EN 455-3:2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 7439:2015 Copper-bearing contraceptive intrauterine devices — Requirements and tests
BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
IEC TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general 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
UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
ISO 13017:2012 Dentistry Magnetic attachments
ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
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
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
UNE-EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
BS EN ISO 11073-30200 : 2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED
BS EN ISO 5840:2009 Cardiovascular implants. Cardiac valve prostheses
UNE-EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
I.S. EN ISO 11979-9:2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
BS EN ISO 10451:2010 Dentistry. Contents of technical file for dental implant systems
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
UNE-EN ISO 11979-6:2015 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
BS EN 14065:2016 Textiles. Laundry processed textiles. Biocontamination control system
ISO 19054:2005 Rail systems for supporting medical equipment
BS EN ISO 10993-13:2010 Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 16201:2006 Technical aids for persons with disability — Environmental control systems for daily living
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 9680:2014 Dentistry Operating lights
ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
BS EN ISO 15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
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
UNE-EN ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
BS EN ISO 22794:2009 Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
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
04/30106146 DC : DRAFT MARCH 2004 BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN 1641:2004 Dentistry. Medical devices for dentistry. Materials
BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
DIN EN 80369-5:2017-10 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017)
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 15908:2010 Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
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 16372:2014 Aesthetic surgery services
EN 1865-2:2010+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
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 26722:2015 Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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 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 16201:2006 Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNI EN ISO 9680 : 2015 DENTISTRY - OPERATING LIGHTS
EN ISO 22803:2005 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
EN ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
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 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
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 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
EN ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
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 14065:2016 Textiles - Laundry processed textiles - Biocontamination control system
EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
EN ISO 13940:2016 Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
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 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN ISO 13958:2015 Concentrates for haemodialysis and related therapies (ISO 13958:2014)
EN 1865-3:2012+A1:2015 (edition 2) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
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 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
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 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
EN ISO 15621:2017 Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
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 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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 980:2008 Symbols for use in the labelling of medical devices
EN ISO 23907:2012 Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012)
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
EN ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
DIN ISO 10083:2008-12 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
08/30156451 DC : DRAFT AUG 2008 BS EN ISO 10993-13 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
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
BS EN 1865-3 : 2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
12/30262133 DC : 0 BS ISO 11197 - MEDICAL SUPPLY UNITS
BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
AAMI ISO 14155-1 : 2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
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)