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Document 02021D1182-20220517

Consolidated text: Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

ELI: http://data.europa.eu/eli/dec_impl/2021/1182/2022-05-17

02021D1182 — EN — 17.05.2022 — 002.001


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►B

COMMISSION IMPLEMENTING DECISION (EU) 2021/1182

of 16 July 2021

on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

(OJ L 256 19.7.2021, p. 100)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING DECISION (EU) 2022/6 of 4 January 2022

  L 1

11

5.1.2022

►M2

COMMISSION IMPLEMENTING DECISION (EU) 2022/757 of 11 May 2022

  L 138

27

17.5.2022




▼B

COMMISSION IMPLEMENTING DECISION (EU) 2021/1182

of 16 July 2021

on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council



Article 1

The references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.




ANNEX



No

Reference of the standard

1.

EN ISO 10993-23:2021

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

2.

EN ISO 11135:2014

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)

EN ISO 11135:2014/A1:2019

3.

EN ISO 11137-1:2015

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)

EN ISO 11137-1:2015/A2:2019

4.

EN ISO 11737-2:2020

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)

5.

EN ISO 25424:2019

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)

▼M1

6.

EN ISO 10993-9:2021

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

7.

EN ISO 10993-12:2021

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

8.

EN ISO 11737-1:2018

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

EN ISO 11737-1:2018/A1:2021

9.

EN ISO 13408-6:2021

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

▼M2

10.

EN ISO 13485:2016

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

EN ISO 13485:2016/AC:2018

EN ISO 13485:2016/A11:2021

▼M1

11.

EN ISO 14160:2021

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)

12.

EN ISO 15223-1:2021

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

13.

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)

14.

EN IEC 60601-2-83:2020

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

EN IEC 60601-2-83:2020/A11:2021

▼M2

15.

EN 285:2015+A1:2021

Sterilization – Steam sterilizers – Large sterilizers

16.

EN ISO 14971:2019

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

EN ISO 14971:2019/A11:2021

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