Implantable medical device products

Implantable medical device products, Total:362 items.

The international standard classification for "Implantable medical device products" includes: Implants for surgery, prosthetics and orthotics , Medical equipment , Sterilization and disinfection in general , Surgical instruments and materials , Medical equipment in general .

The Chinese standard classification for "Implantable medical device products" includes: Extracorporeal circulation, artificial organ and prosthesis device , Orthopedic devices , Medical apparatus and devices in general , Public medical equipment , Other special devices .

国家食品药品监督管理局

YY/T 1575-2017 Tissue engineering medical device products—Standard guide for in vivo assessment of implantable devices intended to repair or regenerate bone defect
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems
YY/T 1445-2016 Tissue engineering medical device products--Terminology
YY/T 0972-2016 Active implantable medical devices-Four-pole connector system for implantable cardiac rhythm management devices-Dimensional and test requirements
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate
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 1576-2017 Tissue engineering medical device products—Standard practice for implantation assessment of absorbable/resorbable biomaterials

Professional Standard - Medicine

YY/T 1874-2023 Active implantable medical devices―Electromagnetic compatibility―EMC test protocols for implantable cardiac pacemakers,implantable cardioverter defibrillators and cardiac resynchronization devices
YY/T 91050-1999 Editorial method for design documents of medical device product
YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices
YY 0989.3-2023 Implants for surgery - Active implantable medical devices - Part 3: implantable neurostimulators
YY/T 0049-1991 Drawings and design document formats for medical devices
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 1427-2016 Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
YY/T 1867-2023 Implants for sport medicine-Suture anchor
YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry-Part 4: Bone implant test

国家药监局

YY/T 1699-2020 Tissue engineering medical device products—Chitosan
YY/T 0989.5-2022 Implants for surgery-Active implantable medical devices-Part 5:Circulatory support devices
YY/T 1737-2020 Analytical method for bioburden control level of medical device
YY/T 1654-2019 Tissue engineering medical device products—Alginate
YY/T 1707-2020 Implants for surgery—Differential scanning calorimetry of poly ether ether ketone (PEEK)polymers and compounds for use in implantable medical devices

未注明发布机构

ANSI/AAMI/ISO 14117:2019 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ANSI/AAMI/ISO 14708-4:2008(2011) Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
ANSI/AAMI/ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 10993-6:2016 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
DIN EN ISO 17664 E:2016-06 Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)
DIN EN ISO 17664-1 E:2021-02 Handling of Healthcare Products Information provided by medical device manufacturers for medical devices Part 1: Critical and semi-critical medical devices (draft)
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ANSI/AAMI/ISO 14708-5:2010(2015) Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
YY 91050-1999 How to prepare medical device product design documents

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

GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
GB 24627-2009 Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6:Tests for local effects after implantation

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

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products
DB4403/T 220-2021 Assignment Rules for Medical Device Product Identification

Group Standards of the People's Republic of China

T/CSBM 0029-2022 Standard guide for in vivo assessment of implantable devices intended to repair or regenerate articular cartilage
T/CASME 962-2023 Code of practice for the management of R&D and design of medical device products

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

CN-CNCA

CNCA 08C-036-2001 Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers

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 14708-2:2019 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 14708-4:2022 Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
ISO/CD 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 14708-7:2019 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 16429:2004 Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO/CD 27186 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 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 14708-2:2005 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

GOST

GOST R ISO 10993.6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-6-2021 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-6-2009 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993.11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies

SCC

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)
BS EN 1642:1997 Dentistry. Medical devices for dentistry. Dental implants
NS-EN 1642:1996 Dentistry — Medical devices for dentistry — Dental implants
NS-EN 1642:2004 Dentistry - Medical devices for dentistry - Dental implants
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)
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)
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)
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)
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-...
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)
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/AB:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
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 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)
CEI UNI EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators
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)
AAMI/ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
DANSK DS/ISO 14708-4:2015 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pumps
CEI UNI EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices Part 4: Implantable infusion pump systems
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)
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
DIN EN 1642 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Dental implants; German version prEN 1642:2008
08/30184615 DC BS EN 1642. Dentistry. Medical devices for dentistry. Dental implants
DIN EN ISO 14708-3:2022 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017); German version EN ISO 14708-3:2022
NS-EN ISO 14708-3:2022 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
DANSK DS/EN ISO 14708-3:2022 Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators (ISO/FDIS 14708-3:2016)
CEI UNI EN ISO 14708-5:2023 Implants for surgery - Active implantable medical devices Part 5: Circulatory support devices
NS-EN ISO 14708-4:2022 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
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
DANSK DS/EN ISO 14708-4:2022 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
DIN EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022); German version EN ISO 14708-4:2022
DANSK DS/EN ISO 14708-2:2022 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers (ISO 14708-2:2019)
DIN ISO 14708-3 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2007)
DIN EN ISO 14708-3 E:2015 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2015); German version prEN ISO 14708-3:2015
NS-EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
BS 5736-2:1981 Evaluation of medical devices for biological hazards-Method of testing by tissue implantation
BS EN ISO 10993-6:2007 Biological evaluation of medical devices-Tests for local effects after implantation
BS 5736-2:1990 Evaluation of medical devices for biological hazards-Methods of testing by tissue implantation
BS EN 30993-6:1995 Biological evaluation of medical devices-Tests for local effects after implantation
CSA ISO 17664-2:2023 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
AAMI/ISO 17664-2:2022 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
DIN ISO 14708-4 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps (ISO/DIS 14708-4:2007)
DANSK DS/ISO 17664-2:2021 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
AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
CAN/CSA-ISO 17664-2-2023 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
AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
DANSK DS/ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS 5736/2PRS:1986 Evaluation of medical devices for biological hazards-Positive control plastic reference standard for implantation
BS PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
AAMI/ISO TIR10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
BS PD ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
NS-EN ISO 17664-2:2023 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)
DANSK DS/EN ISO 14708-5:2022 Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices (ISO 14708-5:2020)
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DANSK DS/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)
DIN EN ISO 14708-5:2022 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020); German version EN ISO 14708-5:2022
08/30192448 DC BS ISO 14708-5. Implants for surgery. Active implantable medical devices. Part 5. Circulatory support devices
CAN/CSA-ISO 17664-1-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
NS-EN ISO 14708-5:2022 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
DANSK DS/ISO 14708-7:2022 Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear and auditory brainstem implant systems
CEI UNI EN ISO 14708-7:2023 Implants for surgery - Active implantable medical devices Part 7: Particular requirements for cochlear and auditory brainstem implant systems
BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
DANSK DS/EN ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
NS-EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
DANSK DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
DIN EN ISO 17664-2 E:2023 Draft Document - 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 and English version prEN ISO 176...
NS-EN 1642:2011 Dentistry — Medical devices for dentistry — Dental implants
DANSK DS/ISO 14708-3:2015 Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
MIL MIL-I-37239-1975 INSERT MOUNTING UNIT, MEDICAL INSTRUMENT AND SUPPLY SET CHEST
NS-EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
AENOR UNE-EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
AENOR UNE-EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and audit brainstem implant systems
NS-EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
DANSK DS/ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
DANSK DS/EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CEI UNI EN 45502-2-3:2010 Active implantable medical devices Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
NS-ISO 10993-6:1994 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CAN/CSA-ISO 10993.6-1997(C2006) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
CAN/CSA-ISO 10993.6-1997(R2006) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
AAMI/ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
MIL MIL-I-37238-1975 INSERT SHELF UNIT, MEDICAL INSTRUMENT AND SUPPLY SET CHEST
MIL MIL-I-37195-1975 INSERT CABINET, MEDICAL INSTRUMENT AND SUPPLY SET CHEST, 5 DRAWER
DIN EN ISO 14708-5 E:2019 Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO/DIS 14708-5:2019); German and English version prEN ISO 14708-5:2019
DIN EN ISO 17664 E:2016 Draft Document - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO/DIS 17664:2016); German and English version prEN ISO 17664:2016
DANSK DS/ISO 14708-1:2015 Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.

GSO

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 ISO 14708-2:2015 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
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)
OS GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14708-3:2024 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
OS GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
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 14708-4:2024 Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
GSO ISO 14117:2015 Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
OS GSO ISO 14708-5:2015 Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
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
GSO ISO 14708-5:2024 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
BH GSO ISO 17664-2:2023 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
GSO ISO 17664-2:2023 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
OS GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
GSO ISO/TS 10974:2016 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
GSO ISO/TR 37137:2024 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
GSO ISO 14708-7:2024 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
BH GSO ISO 14708-7:2022 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
GSO ISO 14708-7:2021 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
GSO EN 1642:2021 Dentistry — Medical devices for dentistry — Dental implants
BH GSO EN 1642:2022 Dentistry — Medical devices for dentistry — Dental implants
BH GSO ISO 14117:2017 Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14117:2024 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO ISO 10993-6:2015 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
BH GSO ISO 10993-6:2017 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

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)
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 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
UNE-EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

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 EN ISO 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques
NF S90-480:1987 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIOVASCULAR IMPLANTS. CARDIAC VALVE PROSTHESES.
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 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 S91-160*NF EN 1642:2013 Dentistry - Medical devices for dentistry - Dental implants
NF EN ISO 14708-4:2022 Surgical implants - Active implantable medical devices - Part 4: Implantable infusion pump systems
NF EN ISO 14708-5:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5 : Dispositifs d'assistance circulatoire
NF S98-116-2*NF ISO 17664-2:2021 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
NF EN 1642:2013 Oral medicine - Medical devices for oral medicine - Dental implants
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)
FD ISO/TR 37137:2014 Évaluation biologique cardiovasculaire des dispositifs médicaux - Directives pour les implants absorbables
FD S99-516*FD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
NF EN ISO 14708-3:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3 : Neurostimulateurs en implant
NF EN 45502-2-3:2010 Dispositifs médicaux implantables actifs - Partie 2-3 : exigences particulières pour les systèmes d'implant cochléaire et les systèmes d'implant auditif du tronc cérébral
NF EN ISO 14708-7:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7 : Exigences particulières pour les systèmes d'implant cochléaire et d'implant auditif du tronc cérébral
NF S98-116-1*NF EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : critical and semi-critical medical devices
NF EN ISO 10993-6:2017 Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
NF S90-750:1989 MEDICAL-SURGERY EQUIPMENT. OPHTALMIC MATEIRALS,DEVICES AND IMPLANTS. CLASSIFICATION,VOCABULARY AND SYMBOLS.
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
NF S94-751:2013 Ophthalmic implants - Ophthalmic viscosurgical devices

ES-UNE

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 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 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
UNE-EN ISO 14708-2:2023 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
UNE-EN ISO 14708-5:2023 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
UNE-EN ISO 14708-7:2023 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
UNE-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 (Endorsed by AENOR in July of 2015.)

British Standards Institution (BSI)

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 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 1642:2009 Dentistry - Medical devices for dentistry - Dental implants
BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices
BS 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)
BS EN 45502-2-1:2004 Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
18/30343606 DC BS EN 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)
BS EN 45502-2-3:2010 Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS ISO 14117:2013 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
BS PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN ISO 10993-6:2016 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 14708-3:2022 Implants for surgery. Active implantable medical devices - Implantable neurostimulators
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
24/30453873 DC BS EN ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
BS EN ISO 14708-2:2022 Implants for surgery. Active implantable medical devices - Cardiac pacemakers
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 ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices

DIN

DIN EN 1642:2004 Dentistry - Medical devices for dentistry - Dental implants
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

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI/AAMI/ISO 17664-2:2022 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
ANSI/AAMI/ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

RU-GOST R

GOST R ISO 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
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 ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems
GOST R 57505-2017 Medical devices. Cochlear implant system. Technical requirements for governmental purchases
GOST R 57500-2017 Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST R 57495-2017 Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

Korean Agency for Technology and Standards (KATS)

KS P ISO 14708-3:2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-3-2010(2016) Implants for surgery－Active implantable medical devices－Part 3：Implantable neurostimulators
KS P ISO 14708-4:2021 Implants for surgery — Active implantable medical devices —Part 4: Implantable infusion pumps
KS P ISO 14708-4-2010(2016) Implants for surgery－Active implantable medical devices－Part 4：Implantable infusion pumps
KS P ISO 14708-2:2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 14708-5-2012(2017) Implants for surgery－Active implantable medical devices－Part 5：Circulatory support devices
KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
KS P ISO 16429:2010 Implants for surgery－Measurements of open-circuit potential to assess corrosion behaviour of etallic implantable materials and medical devices over extended time periods
KS P ISO 10993-6-2023 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
KS P ISO TR 37137:2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS P ISO 16429-2010(2016) Implants for surgery－Measurements of open-circuit potential to assess corrosion behaviour of etallic implantable materials and medical devices over extended time periods
KS P ISO 14708-2:2014 Implants for surgery－Active implantable medical devices－Part 2：Cardiac pacemakers

KR-KS

KS P ISO 14708-3-2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-4-2021 Implants for surgery — Active implantable medical devices —Part 4: Implantable infusion pumps
KS P ISO 14708-2-2020 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
KS P ISO 17664-2-2022 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
KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
KS P ISO TR 37137-2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS P ISO 10993-6-2018(2023) Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
KS P ISO 14708-1-2018(2023) Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

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 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)
LST EN 45502-2-2-2008/AC-2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
LST EN 1642-2012 Dentistry - Medical devices for dentistry - Dental implants

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 17664-2:2021 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
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)
DS/EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices

German Institute for Standardization

DIN EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2011
DIN EN ISO 17664-1:2021-11 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
DIN 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); German version EN 45502-2-2:2008
DIN EN ISO 17664-2:2023 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 and English version prEN ISO 17664-2:2023
DIN EN ISO 17664-2:2024-04 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
DIN 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); German version EN 45502-2-1:2003
DIN EN ISO 10993-6:2017-09 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
DIN EN 1642:2010 Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2009
DIN 96112:2010 Medical instruments - Gauges type Killian-Claus, bayonet-shaped

European Committee for Standardization (CEN)

EN 1642:2009 Dentistry - Medical devices for dentistry - Dental implants
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)
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)
EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN ISO 17664-2:2023 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)
EN ISO 14708-2:2022 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)

US-AAMI

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

International Electrotechnical Commission (IEC)

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
ISO/TS 10974:2012 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
IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0750-20-2-2018 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO/DIS 14708-2:2018); German and English version prEN ISO 14708-2:2018
VDE 0750-20-5-2019 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO/DIS 14708-5:2019); German and English version prEN ISO 14708-5:2019

American Society for Testing and Materials (ASTM)

ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
ASTM F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

European Committee for Electrotechnical Standardization（CENELEC）

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) (Incorporating corrigendum April 2009)
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)

AT-ON

OENORM EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2021)

CH-SNV

SN EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

IX-EU/EC

TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.1/3-1998 GUIDELINES RELATING TO THE DEMARCATION BETWEEN - DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES - DIRECTIVE 93/42/EEC ON MEDICAL DEVICES AND -DIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTS AND RELATED DIRECTIVES (Rev 5.1)

CENELEC - European Committee for Electrotechnical Standardization

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

CEN - European Committee for Standardization

EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

VN-TCVN

TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation

TH-TISI

TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation

Others: Magnetic resonance imaging of patients with active implantable medical devices,Safety assessment of patients with active implantable medical devices using magnetic resonance imaging,MRI safety assessment of patients with active implantable medical devices