整合規格 リスト一覧（MDR：医療機器）
2026年1月30日現在、48 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 |
| 26 | EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) |
(EU) 2024/2631 |
| 27 | EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes |
(EU) 2025/681 |
| 28 | EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties |
(EU) 2025/681 |
| 29 | EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices |
(EU) 2025/681 |
| 30 | EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices |
(EU) 2025/681 |
| 31 | EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher |
(EU) 2025/681 |
| 32 | EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs |
(EU) 2025/681 |
| 33 | EN 13795-1:2025 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns |
(EU) 2025/2078 |
| 34 | EN 13795-2:2025 Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits |
(EU) 2025/2078 |
| 35 | EN 14683:2025 Medical face masks – Requirements and test methods |
(EU) 2025/2078 |
| 36 | EN 14180:2025 Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing |
(EU) 2025/2078 |
|
37 |
EN ISO 7197:2024 Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024) |
(EU) 2026/193 |
|
38 |
EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) EN ISO 10993-4:2017/A1:2025 |
(EU) 2026/193 |
|
39 |
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020) EN ISO 14155:2020/A11:2024 |
(EU) 2026/193 |
|
40 |
EN ISO 14630:2024 Non-active surgical implants – General requirements (ISO 14630:2024) |
(EU) 2026/193 |
|
41 |
EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
(EU) 2026/193 |
|
42 |
EN ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) |
(EU) 2026/193 |
|
43 |
EN ISO 18562-2:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) |
(EU) 2026/193 |
|
44 |
EN ISO 18562-3:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) |
(EU) 2026/193 |
|
45 |
EN ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024) |
(EU) 2026/193 |
|
46 |
EN ISO 21535:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
(EU) 2026/193 |
|
47 |
EN ISO 21536:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023) |
(EU) 2026/193 |
|
48 |
EN ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06) |
(EU) 2026/193 |
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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/medical-devices_en