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ISO 17665-1:2006

Current
Current

The latest, up-to-date edition.

Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Available format(s)

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

Language(s)

English, French, Russian

Published date

17-08-2006

ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:

  • saturated steam venting systems;
  • saturated steam active air removal systems;
  • air steam mixtures;
  • water spray;
  • water immersion.

DevelopmentNote
Supersedes ISO 13683, ISO 11134 and ISO/DIS 17665-1 (08/2006)
DocumentType
Standard
Pages
38
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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BS ISO 11040-6:2012 Prefilled syringes Plastic barrels for injectables
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UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
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DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
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 11140-4:2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
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ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
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UNE-EN ISO 14161:2010 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
ISO 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters
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ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
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EN ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
UNI EN ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
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DIN EN ISO 25539-3:2012-03 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
UNI EN ISO 13408-5 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
CSA Z14161 : 2011 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
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BS ISO 18241:2016 Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps
15/30321508 DC : 0 BS EN ISO 11138-3 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
BS ISO 15674:2009 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
AAMI ISO 11140-5 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
16/30302520 DC : 0 BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
CSA Z11138-1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 11140-4 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
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
CAN/CSA-ISO 11138-1:17 Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
AAMI ISO 22442-3 : 2007 : R2011 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
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ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
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
BS ISO 7199 : 2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
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
ANSI/AAMI/ISO 15676:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
AAMI ISO 8638 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
AAMI ISO 11737-2 :2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
AAMI ISO 8638 : 2010 : R2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
UNE-EN ISO 1135-5:2016 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
CAN/CSA-ISO 11138-3:17 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (Adopted ISO 11138-3:2017, third edition, 2017-03)
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
AAMI ISO 13408-2 : 2003 : R2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
EN ISO 6710:2017 Single-use containers for human venous blood specimen collection (ISO 6710:2017)
ANSI/AAMI/IEC TIR62354:2015 GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT
EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
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)
AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
DIN EN ISO 22442-3:2008-03 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
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 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators General requirements
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 1639:2009 Dentistry. Medical devices for dentistry. Instruments
BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Application of risk management
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
BS EN ISO 8536-8:2015 Infusion equipment for medical use Infusion sets for single use with pressure infusion apparatus
I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
I.S. EN ISO 8536-10:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015)
I.S. EN ISO 8536-11:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015)
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 1135-4:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
I.S. EN ISO 11138-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
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
ONORM EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
I.S. EN ISO 17510-1:2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
I.S. EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
I.S. EN ISO 11140-3:2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
I.S. EN ISO 14160:2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
I.S. EN ISO 11138-1:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. EN ISO 10451:2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
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)
UNI EN ISO 11737-2 : 2010 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
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 8536-8:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)
I.S. EN ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
I.S. EN ISO 16672:2015 OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
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)
DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
UNE-EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
DIN EN ISO 8637:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
PREN 556-2 : DRAFT 2014 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
DIN EN ISO 10555-6 E : 2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
16/30348158 DC : 0 BS EN ISO 6710 - SINGLE-USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION
10/30196945 DC : 0 BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
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)
11/30215841 DC : 0 BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS
I.S. EN ISO 10555-1:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
14/30255135 DC : 0 BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
BS ISO 15675:2009 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
BS ISO 10555-6 : 2015 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
ISO 8637-1:2017 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
16/30330536 DC : 0 BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
13/30254718 DC : 0 BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 8637 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques
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
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
13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN ISO 1135-5 E : 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS ISO 28620:2010 Medical devices. Non-electrically driven portable infusion devices
11/30193150 DC : 0 BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN ISO 13408-5:2011 Aseptic processing of health care products Sterilization in place
AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
15/30329923 DC : 0 BS EN ISO 22610 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION
UNE-EN 16372:2015 Aesthetic surgery services
CSA Z11138-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
BS ISO 11140-5:2007 Sterilization of health care products. Chemical indicators Class 2 indicators for Bowie and Dick-type air removal tests
12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
UNI EN ISO 20072 : 2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
08/30178723 DC : DRAFT AUG 2008 BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
CSA ISO 8638 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
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
AAMI ISO 11140-5 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
ISO 18241:2016 Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps
ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
ANSI/AAMI/ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
AAMI ISO 25539-3 : 2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
I.S. EN ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
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 18241:2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
EN 13060:2014 Small steam sterilizers
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
I.S. EN ISO 8637:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
AAMI ISO 13408-5:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
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
AAMI ISO 13408-2 : 2003 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
I.S. EN ISO 7199:2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
AAMI ISO 11737-1 : 2006 : R2011 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
I.S. EN ISO 8638:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
IEC TR 62354:2014 General testing procedures for medical electrical equipment
I.S. EN ISO 25539-3:2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011)
UNI EN ISO 25539-3 : 2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
BS EN ISO 10555-6:2017 Intravascular catheters. Sterile and single-use catheters Subcutaneous implanted ports
UNI EN ISO 8637 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
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
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
ISO 10555-6:2015 Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports
ISO 6710:2017 Single-use containers for human venous blood specimen collection
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 13060:2015-03 SMALL STEAM STERILIZERS
DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
DIN EN ISO 8536-10:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015)
DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
DIN EN ISO 8536-9:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)
BS EN ISO 8536-10:2015 Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment
ISO 1135-5:2015 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
UNI EN ISO 8536-4 : 2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
BS EN ISO 11138-3:2017 Sterilization of health care products. Biological indicators Biological indicators for moist heat sterilization processes
BS EN ISO 1135-4:2015 Transfusion equipment for medical use Transfusion sets for single use, gravity feed
UNE-EN ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
UNE-EN ISO 14160:2012 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
BS EN 30-1-2:2012 Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills
I.S. EN ISO 14161:2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
I.S. EN ISO 11737-2:2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
I.S. EN ISO 15883-1:2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
ONORM EN ISO 15798 : 2013 AMD 1 2018 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
UNI EN ISO 10451 : 2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
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 ISO 15883-1 : 2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
UNI EN ISO 11140-3 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI EN ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
AAMI ISO 11607-1 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
CSA ISO 11607-1 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
BS EN ISO 25539-2:2012 Cardiovascular implants. Endovascular devices Vascular stents
ISO 18746:2016 Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
PREN ISO 14160 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
BS ISO 17218:2014 Sterile acupuncture needles for single use
BS ISO 11040-7:2015 Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling
DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
AAMI ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
I.S. EN 556-2:2015 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
BS EN ISO 13504:2012 Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
14/30295064 DC : 0 BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
09/30180393 DC : 0 BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
AAMI ISO 8637 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
17/30302489 DC : DRAFT MAR 2017 BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
ONORM EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
UNI EN ISO 13504 : 2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
09/30157765 DC : 0 BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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
12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
16/30331653 DC : 0 BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 18369-1:2017 Ophthalmic optics. Contact lenses Vocabulary, classification system and recommendations for labelling specifications
07/30163423 DC : 0 BS ISO 24998 - PLASTICS LABORATORY WARE - SINGLE USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
07/30145258 DC : 0 BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
AAMI ISO 11140-3 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
CSA Z11140.1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
UNI EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
CSA Z11138-1 : 2007 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
AAMI ISO 11140-3 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
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
AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
CSA Z11140.1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
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
UNI EN ISO 8638 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
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 TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
I.S. EN ISO 1135-3:2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
ANSI/AAMI/ISO 11138-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
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 11607-1:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
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
ISO 17218:2014 Sterile acupuncture needles for single use
UNI EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
ISO 13485 - PRACTICAL GUIDE : 2016 ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
UNE-EN 13060:2015 Small steam sterilizers
I.S. EN ISO 24998:2008 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
ISO 15674:2016 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
UNE-EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
I.S. EN ISO 8536-4:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010)
DIN EN ISO 8536-11:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015)
DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 14160:2011-10 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
DIN EN ISO 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 8536-4:2013-07 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013)
DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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
UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
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
BS EN ISO 11140-4:2007 Sterilization of health care products. Chemical indicators Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO 8536-10:2015 Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment
ISO 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ANSI/AAMI/ISO 15882:2008(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE-EN ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
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 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
UNE-EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
UNE-EN ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 16672:2015 Ophthalmic implants Ocular endotamponades
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
BS EN 13060 : 2014 SMALL STEAM STERILIZERS
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
ISO 8536-8:2015 Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus
ISO 8536-9:2015 Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 8536-11:2015 Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
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)
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
BS EN ISO 10451:2010 Dentistry. Contents of technical file for dental implant systems
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
BS EN ISO 15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
EN 30-1-2:2012 Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills
EN 16372:2014 Aesthetic surgery services
EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
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 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
EN ISO 24998:2008 Plastics laboratory ware - Single-use Petri dishes for microbiological procedures (ISO 24998:2008)
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 ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
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 ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
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 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
EN ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
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 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
EN ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
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)
AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
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
DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
ANSI/AAMI/ISO 14937:2009(R2013) 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
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
PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
I.S. EN ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
BS EN 16372:2014 Aesthetic surgery services
EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
16/30331656 DC : 0 BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS
BS EN ISO 1135-3:2017 Transfusion equipment for medical use Blood-taking sets for single use
ISO 18242:2016 Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
I.S. EN ISO 13504:2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
08/30170025 DC : DRAFT AUG 2008 BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
UNE-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 18472:2006-10 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
CSA Z15882 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
BS EN ISO 25539-3:2011 Cardiovascular implants. Endovascular devices Vena cava filters
17/30326683 DC : DRAFT SEP 2017 BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES
DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
AAMI ISO 7199 : 2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
ANSI/AAMI/ISO 11607-1:2006/(R)2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
UNE-EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
I.S. EN 13060:2014 SMALL STEAM STERILIZERS
CSA ISO 8638 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
13/30283694 DC : 0 BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ANSI/AAMI/ISO 14160:2011(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
CSA Z11138-1 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
BS EN ISO 11607-1 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
DIN EN ISO 11737-1:2009-09 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
AAMI ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 11040-7:2015 Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling
UNI EN ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
AAMI ISO 18472 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
BS ISO 19979:2018 Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
17/30362728 DC : 0 BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
UNI EN ISO 24998 : 2009 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
UNI EN ISO 22794 : 2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA ISO 11140-1 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
ISO 28620:2010 Medical devices Non-electrically driven portable infusion devices
I.S. EN ISO 20072:2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
DIN EN ISO 15883-1:2014-10 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
DIN EN ISO 11138-3:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
DIN EN ISO 8536-8:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)
UNE-EN ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
UNE-EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
BS EN ISO 11140-3:2009 Sterilization of health care products. Chemical indicators Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 8536-11:2015 Infusion equipment for medical use Infusion filters for single use with pressure infusion equipment
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17510-1:2007 Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment
EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
BS EN ISO 16672:2015 Ophthalmic implants. Ocular endotamponades
PD IEC/TR 62354:2014 General testing procedures for medical electrical equipment
ISO 14630:2012 Non-active surgical implants General requirements
ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
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
EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
DIN EN ISO 14937:2010-03 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)
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)

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
EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 14001:2015 Environmental management systems — Requirements with guidance for use
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015 Quality management systems — Requirements
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN 13060:2014 Small steam sterilizers
EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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