整合規格 リスト一覧（MDR：医療機器）
2024年3月6日現在、25 の規格が、MDR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 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
(EU) 2021/1182 |
| 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 |
(EU) 2021/1182 |
| 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 |
(EU) 2021/1182 |
| 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) |
(EU) 2021/1182 |
| 5 | 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) 2023/1410 |
| 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) |
(EU) 2022/6 |
| 7 | EN ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
(EU) 2022/6 |
| 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 |
(EU) 2022/6 |
| 9 | EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
(EU) 2022/6 |
| 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 |
(EU) 2022/757 |
| 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) |
(EU) 2022/6 |
| 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) |
(EU) 2022/6 |
| 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) |
(EU) 2022/6 |
| 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 |
(EU) 2022/6 |
| 15 | EN 285:2015+A1:2021 Sterilization – Steam sterilizers – Large sterilizers |
(EU) 2022/757 |
| 16 | EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) EN ISO 14971:2019/A11:2021 |
(EU) 2022/757 |
| 17 | EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021) |
(EU) 2023/1410 |
| 18 | EN 455-3:2023 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
(EU) 2024/815 |
| 19 | EN ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) |
(EU) 2024/815 |
| 20 | EN ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
(EU) 2024/815 |
| 21 | EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) EN ISO 10993-18:2020/A1:2023 |
(EU) 2024/815 |
| 22 | 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) 2024/815 |
| 23 | 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) 2024/815 |
| 24 | 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) 2024/815 |
| 25 | EN ISO 17664-2:2023 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021) |
(EU) 2024/815 |
規制対応のための重要資料のページではそれぞれの欧州委員会実施決定について紹介しています。詳細はこちらよりご参照ください。
弊社による欧州CEマーキングに関するコンサルティング・ご支援内容についてはこちらよりご確認ください。
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/medical-devices_en