Summary of references of harmonised standards published in the Official Journal – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
The summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L or C series of the OJ as indicated in columns (2), (5) and/or (7). It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.
The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects.
This summary was generated on 17 May 2022.
| Legislation reference (A) | ESO (B) | Reference number of the standard (C) | Title of the standard (D) | (1) | (2) | (3) | (4) | (5) | (6) | (7) |
|---|---|---|---|---|---|---|---|---|---|---|
| 2017/745 | CEN | EN 285:2015+A1:2021 | Sterilization – Steam sterilizers – Large sterilizers | 17/05/2022 | OJ L 138 – 17/05/2022 |
– | – | – | ||
| 2017/745 | CEN | 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) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | CEN | EN ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | CEN | EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) | 19/07/2021 | OJ L 256 – 19/07/2021 | – | – | – | ||
| 2017/745 | CEN | EN ISO 11135:2014, EN ISO 11135:2014/A1:2019 |
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) | 19/07/2021 | OJ L 256 – 19/07/2021 | – | – | – | ||
| 2017/745 | CEN | EN ISO 11137-1:2015, EN ISO 11137-1:2015/A2:2019 |
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) |
19/07/2021 | OJ L 256 – 19/07/2021 | – | – | – | ||
| 2017/745 | CEN | EN ISO 11737-1:2018, EN ISO 11737-1:2018/A1:2021 |
Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737- 1:2018) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | CEN | 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) |
19/07/2021 | OJ L 256 – 19/07/2021 | – | – | – | ||
| 2017/745 | CEN | EN ISO 13408-6:2021 | Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) | 05/01/2022 | OJ L 1 – 05/01/2022 |
– | – | – | ||
| 2017/745 | CEN | EN ISO 13485:2016, EN ISO 13485:2016/A11:2021 |
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | 05/01/2022 | OJ L 138 – 17/05/2022 | |
| 2017/745 | CEN | EN ISO 13485:2016, EN ISO 13485:2016/A11:2021, EN ISO 13485:2016/AC:2018 |
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | 17/05/2022 | OJ L 138 – 17/05/2022 | – | – | – | ||
| 2017/745 | CEN | 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) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | CEN | EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 |
Medical devices – Application of risk management to medical devices (ISO 14971:2019) | 17/05/2022 | OJ L 138 – 17/05/2022 | – | – | – | ||
| 2017/745 | CEN | 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) | 05/01/2022 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | 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) | 05/01/2022 | OJ L 138 – 17/05/2022 | – | – | – | ||
| 2017/745 | CEN | 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) | 19/07/2021 | OJ L 1 – 05/01/2022 | – | – | – | ||
| 2017/745 | Cenelec | EN IEC 60601-2-83:2020, EN IEC 60601-2-83:2020/A11:2021 |
Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | 05/01/2022 | OJ L 138 – 17/05/2022 | – | – | – |
Column legend
Reference information on legislation and standards
(A) Reference number of a relevant Directive or Regulation under which it was published in the OJ
(B) European standardisation organisation that adopted the relevant standard
(C) Reference number of a relevant European standard or of a European standard and its amendment(s)
(D) Title of a European standard
Dates and OJ references for establishing a presumption of conformity
(1) Date when a presumption of conformity starts or started in cases where a reference was published in the OJ without restriction. This date is usually, but not always, the same as the OJ reference date in column (2)
(2) Reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference was published in the OJ without restriction
Dates and OJ references for establishing a presumption of conformity with restriction
(3) Restriction published in the OJ to restrict a presumption of conformity – this includes restrictions on the basis of formal objections
(4) Date when a presumption of conformity with restriction starts or started in cases where a reference was published in the OJ with restriction. This date is usually, but not always, the same as the date in column (5)
(5) Reference number and date of a relevant publication in the L or C series of the OJ in cases where a reference was published in the OJ with restriction
Dates and OJ references for ending a presumption of conformity
(6) Date when a presumption of conformity ends or ended
(7) Reference number and date of a relevant publication in the L or C series of the OJ where the date of withdrawal from the OJ (date in column (6)) was published