EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 02021D1195-20220512
Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Consolidated text: Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
ELI: http://data.europa.eu/eli/dec_impl/2021/1195/2022-05-12
02021D1195 — EN — 12.05.2022 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
|
COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 of 19 July 2021 (OJ L 258 20.7.2021, p. 50) |
Amended by:
|
|
|
Official Journal |
||
|
No |
page |
date |
||
|
COMMISSION IMPLEMENTING DECISION (EU) 2022/15 of 6 January 2022 |
L 4 |
16 |
7.1.2022 |
|
|
COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 |
L 135 |
31 |
12.5.2022 |
|
COMMISSION IMPLEMENTING DECISION (EU) 2021/1195
of 19 July 2021
on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Article 1
The references of harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 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 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 |
|
2. |
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 |
|
3. |
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) |
|
4. |
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) |
|
5. |
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 |
|
6. |
EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
|
7. |
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 |
|
8. |
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) |
|
9. |
EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) |
|
10. |
EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) EN ISO 14971:2019/A11:2021 |