Active medical device aging test

Active medical device aging test, Total:284 items.

The international standard classification for "Active medical device aging test" includes: Medical equipment in general , Implants for surgery, prosthetics and orthotics , Sterilization and disinfection in general , Laboratory medicine .

The Chinese standard classification for "Active medical device aging test" includes: General and microsurgical devices , Medical apparatus and devices in general , Orthopedic devices , Public medical equipment .

Professional Standard - Medicine

YY/T 1911-2023 Test method of coagulation for medical devices
YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
YY 0989.3-2023 Implants for surgery - Active implantable medical devices - Part 3: implantable neurostimulators

国家药监局

YY/T 0681.1-2018 Test methods for sterile medical device package―Part 1:Test guide for accelerated aging
YY/T 0989.5-2022 Implants for surgery-Active implantable medical devices-Part 5:Circulatory support devices
YY/T 1808-2021 In vitro skin irritation test for medical devices

未注明发布机构

DIN 58858 E:2014-02 Medical instruments - Director type König
DIN 58857 E:2019-05 Medical instruments - Directors
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
DIN 58853 E:2020-06 Medical instruments - Probes with eye
DIN 58853 E:2014-02 Medical instruments - Probes with eye
DIN 58858 E:2020-06 Medical instruments - Director type König
ANSI/AAMI/ISO 14708-4:2008(2011) Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
ANSI/AAMI/ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
DIN 58855 E:2014-02 Medical instruments - Director type Kirschner
ANSI/AAMI/ISO 14708-5:2010(2015) Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

国家食品药品监督管理局

YY/T 0972-2016 Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional and test requirements
YY/T 1486-2016 Dentistry-General requirements for instruments and related accessories used in dental implant placement and treatment
YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
YY/T 1623-2018 Test method of effectiveness of sterilization processes for reusable medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

Group Standards of the People's Republic of China

T/ZMDS 50002-2021 Medical device - Air purification system validation

Hubei Provincial Standard of the People's Republic of China

DB42/T 2088.2-2023 Hubei Province Drugs, Medical Devices, and Cosmetics Supervision Data Collection Specifications Part 2: Medical Devices

SCC

VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
DANSK DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
NS-EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
CEI EN 45502-2-1:2005 Active implantable medical devices - Part 2: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
AENOR UNE-EN 45502-2-1:2005 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
CEI UNI EN 45502-2-2:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NS-EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AENOR UNE-EN 45502-2-2 CORR:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CEI UNI EN 45502-2-2/AB:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AENOR UNE-EN 45502-2-2:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
DANSK DS/EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
CEI UNI EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DANSK DS/ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
NS-EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
08/30191609 DC BS ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DIN EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019); German version EN ISO 14708-...
DIN EN ISO 14708-6 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators); German and English version prE...
DANSK DS/EN ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
BS 5736-10:1988 Evaluation of medical devices for biological hazards-Method of test for toxicity to cells in culture of extracts from medical devices
DANSK DS/ISO 14708-2:2022 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
CEI UNI EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices Part 2: Cardiac pacemakers
AENOR UNE-EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
DANSK DS/EN 13726-3:2003 Non-active medical devices – Test methods for primary wound dressings – Part 3: Waterproofness
NS-EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
NS-EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
AENOR UNE-ENV 50076:1993 COMPLEMENTARY REQUIREMENTS (TO THE EN 29001 STANDARD) FOR ACTIVE MEDICAL DEVICES. (OFFICIAL VERSION ENV 50076:1990).
BS BIP 0113:2012 Guide to European medical device trials and BS EN ISO 14155
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 13726-6:2003 Non-active medical devices -Test methods for primary wound dressing - Part 6: Odour control
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
NS-EN 13726-6:2003 Non-active medical devices — Test methods for primary wound dressing — Part 6: Odour control
AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
DANSK DS/ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 13726-4:2003 Non-active medical devices – Test methods for primary wound dressings – Part 4: Comformability
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
BS PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
DANSK DS/ISO/TS 23128:2020 Medical devices – Transfusion set and blood bag compatibility test method
BS PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method
BS PD ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
AENOR UNE-EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odor control
CAN/CSA-Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
BS EN ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants
CEI EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
CAN/CSA-Z314.8-2000(R2007) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
BS 5736-3:1981 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
CAN/CSA Z314.8-2000(R2005) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(C2007) Decontamination of reusable medical devices
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog
CEI UNI EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators
CSA Z314.8-14:2014 Decontamination of reusable medical devices
CAN/CSA-Z314.8-2008(C2013) Decontamination of reusable medical devices
CEI UNI EN ISO 14708-5:2023 Implants for surgery - Active implantable medical devices Part 5: Circulatory support devices
AAMI/ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
BS 5736-11:1990 Evaluation of medical devices for biological hazards-Method of test for haemolysis
CSA Z314.0-13:2014 Reprocessing of medical devices — General requirements Proprietary copy
BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
DANSK DS/ISO 14708-4:2015 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pumps
UNE-EN 50103:1997 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY.
DIN EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019); German version EN ISO 14708-2:2022

Association Francaise de Normalisation

NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: special rules for active implantable medical devices intended to treat bradyarrhythmia (pacemakers)
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
NF EN ISO 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques
NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF C74-502-2-1*NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1 : particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
NF EN 50103:2003 Guide pour l'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 à l'industrie des dispositifs médicaux actifs (comprenant les dispositifs actifs implantables)
NF EN ISO 14708-6:2022 Surgical implants - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices designed to treat tachyarrhythmia (including implantable defibrillators)
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
NF EN ISO 14708-5:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5 : Dispositifs d'assistance circulatoire

Lithuanian Standards Office

LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 13726-3-2004 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
LST EN 13726-4-2004 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
LST EN 13726-6-2004 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control

RO-ASRO

STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

American Society for Testing and Materials (ASTM)

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Danish Standards Foundation

DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
DS/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
DS/EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Comformability
DS/EN 13726-6:2003 Non-active medical devices -Test methods for primary wound dressing - Part 6: Odour control

AENOR

UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE-EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
UNE-EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
UNE-EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control

German Institute for Standardization

DIN 58853:2008 Medical instruments - Probes with eye
DIN 58853:2014 Medical instruments - Probes with eye
DIN 58853:2021 Medical instruments - Probes with eye
DIN 58857:2008 Medical instruments - Directors
DIN 58853:1976 Medical instruments; probes with eye
DIN 58855:2008 Medical instruments - Director type Kirschner
DIN 58858:2021 Medical instruments - Director type König
DIN 58858:2014 Medical instruments - Director type König
DIN 58855:2014 Medical instruments - Director type Kirschner
DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN 58858:2008 Medical instruments - Director type K?nig
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN 58267:1974 Medical instruments; needle holder Mathieu's with inside catch
DIN EN 13726-3:2003-08 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness; German version EN 13726-3:2003 / Note: To be replaced by DIN EN 13726 (2021-02).
DIN 58316:2008 Medical instruments - Abdominal spatulas, malleable
DIN 58267:2010 Medical instruments - Needle holder type Mathieu with inside catch
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 5343:2020 Cleanliness of medical devices - Process design and test methods; Text in German and English
DIN EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
prEN 50103-1992 Guidance on the application of ISO 9001/EN 46001 and ISO 9002/EN 46002 for the active (including active implantable) medical device industry
CEN EN 13726-4-2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
CEN EN 13726-3-2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
CEN EN 13726-6-2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control

GSO

BH GSO ASTM F1980:2022 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
GSO ASTM F1980:2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 14708-6:2024 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BH GSO ISO 14708-6:2017 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
OS GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ASTM F1980:2024 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
GSO ISO 14708-2:2015 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
GSO ISO 14708-2:2024 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
BH GSO ISO 14708-2:2017 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure
BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems
OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
OS GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BH GSO ISO 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method
GSO ISO 23128:2022 Medical devices — Transfusion set and blood bag compatibility test method
GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
GSO ISO 14708-3:2024 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
OS GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
GSO ISO 14708-5:2015 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
OS GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
GSO ISO 14708-5:2024 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
OS GSO ISO 14708-5:2015 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
BH GSO ISO 14708-5:2017 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices

ES-UNE

UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
UNE-EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
UNE-EN ISO 14708-5:2023 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

British Standards Institution (BSI)

BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BS ISO 27186:2013 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS ISO 27186:2020 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices
PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN 50103:1996(2000) Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN ISO 10993-14:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics

RU-GOST R

GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R 56328-2014 Medical equipment. Mobile complexes for medical purpose. General specifications and test methods

International Organization for Standardization (ISO)

ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
ISO/CD 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO/CD 27186 Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
ISO 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 27186:2010 Space systems - Programme management - Quality assurance requirements
ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices

IX-EU/EC

MEDDEV 2.1/1-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

DIN

DIN EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023

VDI - Verein Deutscher Ingenieure

VDI/VDE 2426 Blatt 2-1995 Standardized catalogue of medical devices

GOST

GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
KS P ISO 14708-3-2010(2016) Implants for surgery－Active implantable medical devices－Part 3：Implantable neurostimulators
KS P ISO 14708-3:2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-5-2012(2017) Implants for surgery－Active implantable medical devices－Part 5：Circulatory support devices
KS P ISO 14708-4-2010(2016) Implants for surgery－Active implantable medical devices－Part 4：Implantable infusion pumps

US-AAMI

ANSI/AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

KR-KS

KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 14708-3-2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators

International Electrotechnical Commission (IEC)

ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

GOSTR

GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R 58450-2019 Medical devices with measuring functions. Condition monitoring
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

EU/EC - European Union/Commission Legislative Documents

90/385/EEC CORR-2009 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices

IN-BIS

IS 12572 Pt.9-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 9 Test Methods for Skin Irritation from Solid Medical Devices
IS 12572 Pt.8-1988 Guidelines for Biohazard Assessment of Medical Devices Part 8 Skin Irritation Test Methods for Medical Device Extracts
IS 12572 Pt.5-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 5 Test Method for Intradermal Reactivity of Medical Device Extracts

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0750-20-1-2009 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements (ISO/DIS 27186:2008)

Standard Association of Australia （SAA）

AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing

PL-PKN

PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests

CENELEC - European Committee for Electrotechnical Standardization

EN 50103:1995 Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the Active (Including Active Implantable) Medical Device Industry

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