Principles of Medical Devices

Principles of Medical Devices, Total:337 items.

The international standard classification for "Principles of Medical Devices" includes: Medical equipment in general , Laboratory medicine , Medical equipment , Sterilization and disinfection in general , Medical materials , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Principles of Medical Devices" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices , Medical science .

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

GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/Z 44363-2024 Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/T 42062-2022 Medical devices—Application of risk management to medical devices
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system

Professional Standard - Medicine

YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY/T 1465.5-2016 Immunogenic evaluation method of medical devices- Part 5:Determination of a-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody
YY/T 1955-2025 Tissue Engineering Medical Devices Collagen Terminology
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0802-2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Professional Standard - Hygiene

WS/T 654-2019 Safety management for medical devices

Group Standards of the People's Republic of China

T/GDMDMA 0012.1-2022 Specifications for the Management of Medical Equipment in Hospitals - Part 1: General Provisions
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/SXS 128-2023 Medical device safety management requirements specification
T/GDMDMA 0012.5-2022 Hospital Medical Device Management Specification Part 5: Procurement Management
T/CHAS 10-4-7-2021 Quality and safety management of Chinese hospital—— Part 4-7: Medical management —— medical devices management

Gosstandart of Russia

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 R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
GOST R 71737-2024 Artificial intelligence systems in healthcare. Risk management for medical devices. General provisions

Association for the Advancement of Medical Instrumentation

AAMI TIR97:2019(R2023) Principles for medical device security - Postmarket risk management for device manufacturers
AAMI TIR57:2016(R2023) Principles for medical device security - Risk management
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
AAMI TIR34:2014 Water for the reprocessing of medical devices
AAMI TIR34:2007 Water for the reprocessing of medical devices
AAMI TIR34-2014 Water for the reprocessing of medical devices
AAMI TIR34-2014(2017) Water for the reprocessing of medical devices
AAMI TIR34:2014(R2017) Water for the reprocessing of medical devices
AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
AAMI TIR32-2004(2016) Medical device software risk management
AAMI TIR32:2004(R2016) Medical device software risk management
AAMI TIR32:2004 Medical device software risk management
AAMI/ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI/ISO TIR16142:2005 Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
AAMI TIR 12:2020(R2023) Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
AAMI TIR34:2014(R2021) Water for the reprocessing of medical devices
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to 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
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

International Organization for Standardization (ISO)

ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
ISO/TR 16142:1999 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

British Standards Institution (BSI)

DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
BS PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
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
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
05/30140005 DC BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices
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 ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BS PD 6630:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS PD CEN ISO/TR 14969:2005(2006) Medical devices — Quality management systems — Guidance on
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
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
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices

American National Standards Institute （ANSI)

ANSI/AAMI TIR57:2016(R2023) Principles for medical device security - Risk management
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 TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/AAMI TIR97:2019(R2023) Principles for medical device security - Postmarket risk management for device manufacturers
ANSI/AAMI ST90-2017 Processing of health care products—Quality management systems for processing in health care facilities
ANSI/AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI/AAMI/ISO 16142-1:2016 Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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 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

Association Francaise de Normalisation

FD S99-513*FD ISO/TR 21582:2021 Pyrogenicity - Principles and methods for pyrogen testing of medical devices
FD ISO/TR 21582:2021 Pyrogenicity - Principles and test methods for the detection of pyrogens on medical devices
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to obtain the "STERILE" label - Part 2: Requirements for medical devices subject to aseptic processing
XP S99-223:2020 Medical Device - Benefit risk management
XP S99-223:2023 Medical Devices - Benefit risk management
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 EN ISO 10993-17:2023 Biological evaluation of medical devices - Part 17 : toxicological risk assessment of medical device constituents
NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of medical devices
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 S99-172:2017 Use and maintenance of medical devices - Risk management system for risks associated with the use of medical devices

GCC Standardization Organization

BH GSO ISO/TR 21582:2024 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 17664:2014 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
GSO ISO 16142-2:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
GSO ISO 16142-1:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 17664-1:2024 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
BH GSO ISO 17664-1:2024 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
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

Danish Standards Foundation

DANSK DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
DANSK DS/ISO 16142-2:2017 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
DS/ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
DANSK DS/ISO/TR 16142:2006 Medical devices – Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
DANSK DS/ISO 16142-1:2016 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
DANSK DS/CEN/CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
DS/CEN/CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
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
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
DS/EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-20-2009(2024) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
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 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO TR 16142:2007 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142-2007(2012) Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142-2019 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO 16142-2:2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 16142-1:2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 16142-1-2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 16142-2-2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
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 13485:2018 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 13485-2018 Medical devices — Quality management systems — Requirements for regulatory purposes

Kingdom of Bahrain Testing and Metrology Directorate

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 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 16142-2:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-1:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
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

The Directorate General of Specifications and Metrology (DGSM)

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 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

European Committee for Standardization (CEN)

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
EC 1-2010 UNI EN ISO 17664:2005 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
UNI EN ISO 10993-17:2024 Biological evaluation of medical devices - Part 17:Toxicological risk assessment of medical device constituents
UNI 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

Standards Norway

SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
NS-EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
NS-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 14971:2020 Medical devices -- Application of risk management to medical devices

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

Thai Industrial Standards Institute (TISI)

TIS 14971-2013 Medical devices.application of risk management to medical devices

German Institute for Standardization

DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN ISO 15225:2016-11 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
DIN EN ISO 15225:2010-10 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN ISO 14971 E:2018 Draft Document - Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
DIN 13466:1982 Medical instruments; nasal dressing forceps type West
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 EN ISO 15225 E:2015 Draft Document - Medical devices - Quality management - Medical device nomenclature data structure (ISO/DIS 15225:2015); German and English version prEN ISO 15225:2015
DIN EN ISO 17664 E:2016-06 Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)
DIN EN ISO 14971/A1 E:2009-04 Draft Document - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
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
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971/A1:2009 Application of risk management in medical equipment
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)
DIN 13466:2010 Medical instruments - Nasal dressing forceps type West
DIN 58846:1988-07 Medical instruments; raspatories
DIN EN ISO 17664-2 E:2023-09 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...
DIN 13466 E:2008-09 Medical instruments - Nasal dressing forceps type West
DIN 96160:2011-12 Medical instruments - Wire guide
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13119:2010-02 Medical instruments - Bowel scissors
DIN 58857:2019-12 Medical instruments - Directors
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58846:2010-02 Medical instruments - Raspatories
DIN 13185:2005-12 Medical instruments - Onychia forceps
DIN 58852:2008 Medical instruments - Probes
DIN 96056:2016 Medical instruments - Bone raspatory
DIN EN 62304:2016-10*VDE 0750-101:2016-10 Medical device software
DIN 58852:2008-01 Medical instruments - Probes
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
DIN 96056:2023-03 Medical instruments - Bone raspatory

Bureau of Indian Standards

IS 23485-2019 Medical Devices —— Quality Management System Requirements and Essential Principles of Safety and Performance for Medical Devices
IS/ISO/TS 10993-20-2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
IS/ISO 16142-2-2017 Medical devices —— Recognized Essential Principles of Safety and Performance of Medical Devices Part 2 General Essential Principles and Additional Specific Essential Principles for all IVD Medical Devices and Guidance on the Selection of Standards
IS/ISO 16142-1-2016 Medical Devices —— Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards...
IS 18742-2-2024 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

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Spanish Association for Standardization (UNE)

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
UNE-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
UNE-EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
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
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
CAN/CSA Z314-2018 Canadian medical device reprocessing
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
CSA ISO 14971:2021 Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)
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
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
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

Comitato Elettrotecnico Italiano

CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Swedish Institute for Standards

SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
SS-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)
SS-EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
SS-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
SS-EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Indonesia Standards

SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)
SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)
SNI ISO 17664-1:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 1: Alat kesehatan kritikal dan semi kritikal (ISO 17664-1:2021, IDT)
SNI ISO 14971:2015 Alat kesehatan - Penerapan manajemen risiko pada alat kesehatan (ISO 14971:2007, IDT)

Lithuanian Standards Office

LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
LST EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
LST EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 3551:1996 Technical management programs for medical devices

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Association of German Mechanical Engineers

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
VDI/VDE 2426 Blatt 1-2000 Catalogues in maintenance and management of medical devices - General
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog

European Committee for Electrotechnical Standardization（CENELEC）

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

Military Standards (MIL-STD)

MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET