Medical Device Program

Medical Device Program, Total:377 items.

The international standard classification for "Medical Device Program" includes: Medical Sciences and health care facilities in general , Medical equipment in general , Medical equipment .

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

卫生健康委员会

WS/T 654-2019 Safety management for medical devices

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

GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Professional Standard - Medicine

YY/T 91050-1999 Editorial method for design documents of medical device product
YY 91050-1999 How to prepare medical device product design documents
YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
YY/T 0049-1991 Drawings and design document formats for 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 1437-2023 Medical devices-Guidance on the application of GB/T 42062
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
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 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices

Group Standards of the People's Republic of China

T/CASME 962-2023 Code of practice for the management of R&D and design of medical device products
T/SSBME 001-2024 Medical devices - Guidelines for compiling post market study and risk management plans
T/ZGXX 0003-2019 Medical device cleaning agent

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

国家药监局

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Guangdong Provincial Standard of the People's Republic of China

DB4404/T 36-2022 Advance Care Planning (ACP) Communication Guide

SCC

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
ADA 1081-2015 FDA's Unique Device Identifiction (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices - Technical Report
ADA 1081-2019 FDA's Unique Device Identifiction (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices - Technical Report
DANSK DS/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
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
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
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
DIN 96056:2016 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
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
SN-CR 14060:2000 Medical device traceability
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 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
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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)
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
AENOR 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
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
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)
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical 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
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
DIN 96057:2016 Medical instruments - Raspatory type Sedillot
DIN 58318:2019 Medical instruments - Elevators Langenbeck's
DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
DIN 58274:2016 Medical instruments - Iris forceps
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
DIN EN 556-1 E:2023 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
DIN 58319:2019 Medical instruments - Elevators Williger
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 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
DIN 96112 E:2010 Draft Document - Medical instruments - Gauges type Killian-Claus, bayonet-shaped
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)
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)
DIN 58295:2017 Medical instruments - Retractor type Volkmann
DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
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...
DIN 58288:2017 Medical instruments - Retractor type Langenbeck
DIN 58259:2017 Medical instruments - Needle holder type Masson
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
DIN 96160 E:2011 Draft Document - Medical instruments - Wire guide
DIN 58287:2017 Medical instruments - Retractor type KÃ¶rte
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
DIN 58286:2017 Medical instruments - Retractor type Kocher

Korean Agency for Technology and Standards (KATS)

KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
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 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 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 IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices

British Standards Institution (BSI)

BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS EN ISO 14971:2009 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 EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 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 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
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 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
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 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents

German Institute for Standardization

DIN 96115:2010 Medical instruments - Gauges type Lexer
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58794:1982 Medical instruments; ear forceps
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 58852:2008 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58857:2019-12 Medical instruments - Directors
DIN 13117:2013 Medical instruments.Bone shears
DIN 13119:1980 Medical instruments; bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
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 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
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 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58862:1988 Medical instruments; bone curettes
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 58857:1976 Medical instruments; directors
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 58846:1988 Medical instruments; raspatories
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58846:2017 Medical instruments - Raspatories
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13458:2009 Medical instruments - Ligature needle
DIN 58858:2021-02 Medical instruments - Director type König
DIN 58846:2010 Medical instruments - Raspatories
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 13458:1988 Medical instruments; ligature needle
DIN 58846 E:2017-06 Medical instruments - Raspatories
DIN 58259:1976 Medical instruments; needle holder type Masson
DIN 58247 E:2016-07 Medical instruments retractor Roux's
DIN 13176 E:2016-07 Medical instruments - Organ grasping forceps
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 58795:1988 Medical instruments; mouth gags
DIN 58247:2010 Medical instruments - Retractors type Roux
DIN 96053:2009 Medical instruments - Retractor type Ollier
DIN 58285:2008 Medical instruments - Retractor type Volkmann
DIN 58285 E:2014-02 Medical instruments retractor type Volkmann
DIN 58287:1983 Medical instruments; retractor type K?rte
DIN 58312:2010 Medical instruments - Rib contractor
DIN 58247 E:2022-08 Medical instruments retractor Roux's
DIN 58318 E:2019-05 Medical instruments - Elevators Langenbeck's
DIN 58257:1983 Medical instruments; needle holder type Crile
DIN 58286:1983 Medical instruments; retractor type Kocher
DIN 58863:1979 Medical instruments; bone curettes type Volkmann
DIN 13176:2023-03 Medical instruments - Organ grasping forceps
DIN 58285 E:2020-06 Medical instruments retractor type Volkmann
DIN 58855:1983 Medical instruments; director type Kirschner
DIN 58256:1976 Medical instruments; needle holder, type T?nnis
DIN 96053:2021 Medical instruments - Retractor type Ollier
DIN 58259 E:2017-03 Medical instruments needle holder type Masson
DIN 58259:2017-08 Medical instruments; needle holder type Masson
DIN 58248:1983 Medical instruments; retractor type Jansen
DIN 58262:1973 Medical instruments; mouth gag Jennings
DIN 58318:2008 Medical instruments - Elevators Langenbeck's
DIN 58286 E:2017-03 Medical instruments retractor type Kocher
DIN 58287:2017-08 Medical instruments - Retractor type Körte
DIN 13460:2023-03 Medical instruments - Needle holder type Heaney
DIN 58295:2017-08 Medical instruments - Retractor type Volkmann
DIN 58265:1974 Medical instruments; needle holder Finochietto's
DIN 58285:1983 Medical instruments; retractor type Volkmann
DIN 58285:2021 Medical instruments - Retractor type Volkmann
DIN 58247:2016 Medical instruments - Retractors type Roux
DIN 58247:2023-03 Medical instruments - Retractors type Roux
DIN 58290:1972 Medical instruments; retractor Bergmann's
DIN 96053 E:2020-06 Medical instruments - Retractor type Ollier
DIN 58240:1983 Medical instruments; retractors type Israel
DIN 58312:1988 Medical instruments; rib contractor
DIN 58247:1973 Medical instruments; retractor Roux's
DIN 13176:2005 Medical instruments - Organ grasping forceps
DIN 13176 E:2022-08 Medical instruments - Organ grasping forceps
DIN 58285:2021-02 Medical instruments - Retractor type Volkmann
DIN 58249:2023-03 Medical instruments - Retractors type Weitlaner
DIN 58315:1979 Medical instruments; retractors Cushing's
DIN 58249:1983 Medical instruments; retractors type Weitlaner
DIN 58296:1973 Medical instruments; raspatories Semb's
DIN 96149:2011 Medical instruments - Bone curettes type Daubenspeck
DIN 13176:2016 Medical instruments - Organ grasping forceps
DIN 58285:2014 Medical instruments - Retractor type Volkmann
DIN 58288:2017-08 Medical instruments - Retractor type Langenbeck
DIN 96053:2021-02 Medical instruments - Retractor type Ollier
DIN 58286:2017-08 Medical instruments - Retractor type Kocher
DIN 58274:1983 Medical instruments; iris forceps
DIN 58785:2017-08 Medical instruments - Ear specula type Hartmann
DIN 96144:2017 Medical instruments - Raspatories type Williger
DIN 96140 E:2017-06 Medical instruments - Osteotomes type Stille

American National Standards Institute （ANSI)

ADA TR 1081-2023 FDA's Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
ADA TR 1081-2019 FDA's Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
ADA TR 1081-2015 FDA’s Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management 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
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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/NFPA 1582-2013 Standard on Comprehensive Occupational Medical Program for Fire Departments
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
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

RU-GOST R

GOST ISO 14971-2011 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 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized 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 ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software

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 62366-1:2022 Medical devices -- Part 1: 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 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
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'
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)
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

KR-KS

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 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 IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS C IEC 62083-2017 Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems

Association Francaise de Normalisation

NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF S99-211/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 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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
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 S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique

CEN - European Committee for Standardization

EN ISO 14971:2007 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 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 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to 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
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1

South African Bureau of Standard

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

GSO

GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
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
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

GOST

GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices

NATO - North Atlantic Treaty Organization

AJMEDP-1-2009 ALLIED JOINT MEDICAL PLANNING DOCTRINE
AMEDP-8 (A) VOL III-2001 VOLUME III – MEDICAL PLANNING GUIDE OF NBC BATTLE ASUALTIES CHEMICAL

US-FCR

FCR AF I48-119-1994 MEDICAL SERVICE ENVIRONMENTAL QUALITY PROGRAMS
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY

TH-TISI

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

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices

Spanish Association for Standardization (UNE)

UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
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 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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 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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)

Standard Association of Australia （SAA）

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

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/CEN/CR 14060:2001 Medical device traceability
DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
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
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
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 17664-2:2021 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 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

CENELEC - European Committee for Electrotechnical Standardization

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

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 96056:2023 Medical instruments - Bone raspatory
DIN 13173:2023 Medical instruments - Dressing forceps
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
DIN 13176:2023 Medical instruments - Organ grasping forceps
DIN 96057:2023 Medical instruments - Raspatory type Sedillot
DIN 96074:2023 Medical instruments - Elevator type Freer
DIN 58249:2023 Medical instruments - Retractors type Weitlaner
DIN 13460:2023 Medical instruments - Needle holder type Heaney
DIN 58247:2023 Medical instruments - Retractors type Roux

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
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

Lithuanian Standards Office

LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

PL-PKN

PN Z54061-1986 Medical instruments Ears Dimensions
PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices

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)