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Document 02021D1195-20240308
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/2021/1195/2024-03-08
This consolidated text may not include the following amendments:
| Amending act | Amendment type | Subdivision concerned | Date of effect |
|---|---|---|---|
| 32024D2625 | Modified by | annex point 14 | 09/10/2024 |
| 32024D2625 | Modified by | annex point 15 | 09/10/2024 |
02021D1195 — EN — 08.03.2024 — 004.001
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COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 of 19 July 2021 (OJ L 258 20.7.2021, p. 50) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING DECISION (EU) 2022/15 of 6 January 2022 |
L 4 |
16 |
7.1.2022 |
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COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 |
L 135 |
31 |
12.5.2022 |
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COMMISSION IMPLEMENTING DECISION (EU) 2023/1411 of 4 July 2023 |
L 170 |
105 |
5.7.2023 |
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COMMISSION IMPLEMENTING DECISION (EU) 2024/817 of 6 March 2024 |
L 817 |
1 |
8.3.2024 |
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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
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No |
Reference of the standard |
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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 |
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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 |
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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) |
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4. |
EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018) EN ISO 25424:2019/A1:2022 |
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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 |
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6. |
EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
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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 |
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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) |
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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) |
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10. |
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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11. |
EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) EN ISO 11137-2:2015/A1:2023 |
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12. |
EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) EN ISO 11607-1:2020/A1:2023 |
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13. |
EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) EN ISO 11607-2:2020/A1:2023 |