整合規格 リスト一覧（IVDR：体外診断用医療機器）
2024年10月9日現在、15の規格が、IVDRの整合規格として認定されています。
| No | 整合規格 | 委員会実施決定 |
| 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 |
(EU) 2021/1195 |
| 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 |
(EU) 2021/1195 |
| 3 | 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 |
(EU) 2023/1411 |
| 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) |
(EU) 2021/1195 |
| 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 |
(EU) 2022/15 |
| 6 | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
(EU) 2022/15 |
| 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 |
(EU) 2022/729 |
| 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) |
(EU) 2022/15 |
| 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) |
(EU) 2022/15 |
| 10 | EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) EN ISO 14971:2019/A11:2021 |
(EU) 2022/729 |
| 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 |
(EU) 2024/817 |
| 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 |
(EU) 2024/817 |
| 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 |
(EU) 2024/817 |
| 14 | EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) |
(EU) 2024/2625 |
| 15 | EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) |
(EU) 2024/2625 |
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整合規格に関する詳細（最新情報）については以下よりご確認下さい。
https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en