Class II medical device products

Class II medical device products, Total:336 items.

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

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

Guangdong Provincial Standard of the People's Republic of China

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

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

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/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing

国家药品监督管理局

YY/T 1600-2018 Product family and processing category for steam sterilization of medical devices

Professional Standard - Medicine

YY/T 0049-1991 Drawings and design document formats for medical devices
YY/T 0052-1991 Method for changing drawings and design documents of medical devices
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products
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 0047-1991 Terminology of product drawings and design documents of medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY 91050-1999 How to prepare medical device product design documents
YY/T 0050-1991 Numbering principle for medical device drawings and design documents
YY/T 91050-1999 Editorial method for design documents of medical device product
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices

国家食品药品监督管理局

YY/T 1435-2016 Tissue engineering medical device products―Standard guide for characterization of hydrogels
YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products
YY/T 1570-2017 Tissue engineering medical device products—Terminology,classification and nomination of skin substitute
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate
YY/T 1445-2016 Tissue engineering medical device products--Terminology
YY/T 1474-2016 Medical devices－Application of risk management to medical devices

国家药监局

YY/T 1654-2019 Tissue engineering medical device products—Alginate
YY/T 1699-2020 Tissue engineering medical device products—Chitosan

Hubei Provincial Standard of the People's Republic of China

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

Henan Provincial Standard of the People's Republic of China

DB41/T 2656-2024 Product registration self-inspection system requirements for medical device manufacturers

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

GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

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/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices

American National Standards Institute （ANSI)

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
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 17664:2017 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure

Association Francaise de Normalisation

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 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 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
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
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF EN ISO 10993-13:2010 Biological assessment of medical devices - Part 13: identification and quantification of degradation products of polymer-based medical devices
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 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 S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to 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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
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

KR-KS

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 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric 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 10993-13-2018(2023) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric 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 P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems

SCC

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
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 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 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 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)
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
AAMI/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 17664-1:2021 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 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...
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
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.
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)
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)
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)
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
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
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
DIN EN ISO 17664-1 E:2021 Draft Document - 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 17664-1:2020); German and English v...
DIN EN ISO 13408-7 E:2015 Draft Document - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version FprEN ISO 13408-7:2015
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
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
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 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
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 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
NS-EN 1174-1:1996 Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 1: Requirements
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 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed 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
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 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized 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
DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
CAN/CSA-ISO 10993-13-00:2000 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
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
DIN 58858 E:2020 Draft Document - Medical instruments - Director type KÃ¶nig
DANSK DS/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
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices

GSO

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
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
GSO ISO 13408-7:2015 Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
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
BH GSO ISO/TS 17665-3:2017 Sterilization of health care products -- Moist heat -- Part 3:Guidance on the designation of a medical device to a product family and processing category for steam sterilization
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 10993-13:2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
OS GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO/TS 17665-3:2015 Sterilization of health care products -- Moist heat -- Part 3:Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems

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
CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
CAN/CSA-ISO/TS 17665-3:2017 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
CSA ISO 13485-03-CAN/CSA:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition
CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)

GOST

GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
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 ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST R ISO 10993-12-2009 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-14-2009 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-4-2009 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993.12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-12-2023 Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
GOST ISO 10993-15-2023 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993-15-2009 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993.6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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 R ISO 10993.11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-10-2009 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R ISO 10993-17-2009 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substance
GOST R ISO 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R ISO 10993.10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R ISO 10993-7-2009 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-1-2021 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
GOST ISO 10993-9-2022 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R ISO 10993-9-2009 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

Danish Standards Foundation

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/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 17664-1:2021 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/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices

European Committee for Standardization (CEN)

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 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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
EN 1174-2:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 2: Guidance

Spanish Association for Standardization (UNE)

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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 14971:2020/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 ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
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

Korean Agency for Technology and Standards (KATS)

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 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric 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 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P ISO 10993-13-2023 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems

International Organization for Standardization (ISO)

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 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
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 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to 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
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

British Standards Institution (BSI)

19/30378069 DC BS ISO 17664-2. 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
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 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 ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to 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 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable 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 ISO 13408-7:2012 Aseptic processing of health care products. Alternative processes for medical devices and combination products
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric 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
DD ENV 12610-1998 Medical informatics. Medical product identification
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 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. Critical and semi-critical 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)

DIN

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

German Institute for Standardization

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 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 17664-1 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 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 ISO 17664 E:2016-06 Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)
DIN EN ISO 17664-2:2023-09 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 / Note:...
DIN 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); German version EN ISO 17664-1:2021
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 556-1:2023-02 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 556-2:2015-11 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 ISO 14971:2022 Medical devices – applying risk management to medical devices
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 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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 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); German version EN ISO 17664:2017
DIN EN ISO 13408-7:2015-11 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015
DIN 58794:1982 Medical instruments; ear forceps
DIN 96056 E:2015-09 Medical instruments - Bone raspatory

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

RU-GOST R

GOST R 15.013-2016 System of products development and launching into manufacture. 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 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R 57502-2017 Medical equipment. Industrial production regulation
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
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 R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing

TH-TISI

TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
TIS 14971-2013 Medical devices.application of risk management to medical devices

CN-CNCA

CNCA 08C-032-2001 Implementation Rules for Compulsory Certification of Medical Device Products ECG Machine
CNCA 08C-035-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer
CNCA 08C-033-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hemodialysis Devices
CNCA 08C-036-2001 Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

South African Bureau of Standard

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
SANS 14971:2008 Medical devices - Application of risk management to medical devices

IX-EU/EC

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

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

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 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 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

International Electrotechnical Commission (IEC)

IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2014 Medical devices - 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 62366-1:2020 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
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems

GOSTR

GOST R 58163-2018 Sterilization of health care products. Moist heat. Part 3. Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Standard Association of Australia （SAA）

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

PL-PKN

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

US-AAMI

ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

CENELEC - European Committee for Electrotechnical Standardization

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