Summary of references of Harmonised Standards in support of Regulation (EU) 2017/745 on Medical Devices - MDR

Summary of references of Harmonised Standards under the Medical Devices Regulation

Updated as of 17 May 2022

You may track the Standards providing presumption of conformity in the context of the requirements of Regulation (EU) 2017/745 on Medical Devices in a very visual and easy way. Genorma.com has developed a real-time monitoring system to track in real-time the status of European harmonised standards under the Medical Devices Regulation (MDR).

The standards listed below correspond to the consolidation and summary of the following lists of harmonised standards published in the Official Journal:

DISCLAIMER: This is an informative page, providing added value information on standards. Information may evolve and change subject to the publication of other legislative texts. Genorma.com informs its users that users are responsible for deciding the version of the standard that is applicable to their products, and not Genorma.com. As a consequence, Genorma.com users are encouraged to check the latest versions of the legal text accessible through the EUR-LEX website

Sterilization - Steam sterilizers - Large sterilizers

60.60 Standard published

CEN/TC 102

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

CLC/TC 62

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

CLC/TC 62

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

60.60 Standard published

CEN/TC 206

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

60.60 Standard published

CEN/TC 204

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60 Standard published

CEN/TC 204

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

60.60 Standard published

CEN/TC 204

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

CEN/CLC/JTC 3

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)

60.60 Standard published

CEN/TC 204

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

CEN/CLC/JTC 3

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)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

60.60 Standard published

CEN/TC 204