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嘉峪檢測網 2025-05-17 11:06
一晃2025年都要快過半了， 慢吞吞的歐盟終于在距離上次更新MDR協調標準半年之后又更新了清單了
來看看這次更新更新到底有哪些標準：
|
No |
Reference of the standard |
|
27. |
EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes |
|
28. |
EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties |
|
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 |
|
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 |
|
31. |
EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher |
|
32. |
EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs’. |
所以就是更新了兩個一次性醫用手套， 新增了四個標準，分別是兩個醫療器械的滅菌和兩個救護車用病人搬運設備相關標準。所以MDR 的協調標準總數終于上30+了。相關產品的廠家需要注意了，這寫協調標準隨著OJ 發布就生效了，也就說說2025年4月8號開始生效。
MDR 下現有的所有協調標準如下：
|
No. |
Reference number of the standard (C) |
Title of the standard (D) |
|
1 |
EN 285:2015+A1:2021 |
Sterilization - Steam sterilizers - Large sterilizers |
|
2 |
EN 455-3:2023 |
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
|
3 |
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) |
|
4 |
EN ISO 10993-10:2023 |
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021) |
|
5 |
EN ISO 10993-12:2021 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
|
6 |
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) |
|
7 |
EN ISO 10993-17:2023 |
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
|
8 |
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) |
|
9 |
EN ISO 10993-23:2021 |
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
|
10 |
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) |
|
11 |
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) |
|
12 |
EN ISO 11137-2:2015, |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
|
13 |
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) |
|
14 |
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) |
|
15 |
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) |
|
16 |
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) |
|
17 |
EN ISO 13408-1:2024 |
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) |
|
18 |
EN ISO 13408-6:2021 |
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) |
|
19 |
EN ISO 13485:2016, |
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
|
20 |
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) |
|
21 |
EN ISO 14971:2019, |
Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
|
22 |
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) |
|
23 |
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) |
|
24 |
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) |
|
25 |
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) |
|
26 |
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 |
|
27 |
EN 455-1:2020+A2:2024 |
Medical gloves for single use – Part 1: Requirements and testing for freedom of holes |
|
28 |
EN 455-2:2024 |
Medical gloves for single use – Part 2: Requirements and testing for physical properties |
|
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 |
|
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 |
|
31 |
EN 1865-2:2024 |
Patient handling equipment used in ambulances – Part 2: Power assisted stretcher |
|
32 |
EN 1865-6:2024 |
Patient handling equipment used in ambulances – Part 6: Powered chairs’.
|
來源：MD SRE
