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欧亚联盟EAEU委员会发布了EAC医疗器械测试的统一标准

 欧亚联盟委员会已认可国际标准化组织 (ISO) 和国际电气委员会 (IEC) 与医疗器械相关的9 项协调标准。这些ISO和IEC标准的使用与欧洲标准 EN ISO 或 EN IEC 一样。

产品制造商已经制造出符合相关ISO/IEC标准并打算向欧亚联盟EAEU共同市场供应产品的产品制造商可以使用符合性证书来满足欧洲医疗器械法规 (MDR) 的要求。

批准的标准涵盖了许多重要主题,包括医疗器械的生物学评估、灭菌、无菌加工、质量管理体系等。

在欧亚联盟委员会于2021年7月批准5项主题测试标准后不久,9 项协调标准得到批准。因此,根据《医疗器械法规》协调的标准总数已达到14项。完整列表如下:

2021年7月16日委员会实施条例 (EU) 2021/1182 批准的文件:
◾1。 EN ISO 10993-23:2021 医疗器械的生物学评价 - 第 23 部分:刺激试验”
◾2。 EN ISO 11135:2014“保健产品的灭菌——环氧乙烷——医疗器械灭菌过程的开发、验证和常规控制的要求”(ISO 11135:2014)
◾3。 EN ISO 11137-1:2015“医疗保健产品灭菌 - 辐射 - 第 1 部分:医疗器械灭菌过程的开发、验证和常规控制要求”(ISO 11137-1:2006,包括 Amd 1:2013)< /li>
◾4。 EN ISO 11737-2:2020“保健产品的灭菌 - 微生物方法 - 第 2 部分:在灭菌过程的定义、验证和维护中进行的无菌测试”(ISO 11737-2:2019)
◾5。 EN ISO 25424:2019“保健产品的灭菌 - 低温蒸汽和甲醛 - 医疗器械灭菌过程的开发、验证和常规控制要求”(ISO 25424:2018)

2022年1月4日委员会实施条例 (EU) 2022/6 批准的文件:
◾6。 EN ISO 10993-9:2021“医疗器械的生物学评估 - 第 9 部分:潜在降解产物的识别和量化框架”(ISO 10993-9:2019)
◾7。 EN ISO 10993-12:2021“医疗器械的生物学评估 - 第 12 部分:样品制备和参考材料”(ISO 10993-12:2021)
◾8。 EN ISO 11737-1:2018“保健产品的灭菌——微生物方法——第 1 部分:产品上微生物种群的测定”(ISO 11737-1:2018)
◾9。 EN ISO 13408-6:2021 “保健产品的无菌处理 - 第 6 部分:隔离系统” (ISO 13408-6:2021)
◾10。 EN ISO 13485:2016 “医疗器械 — 质量管理体系 — 监管要求” (ISO 13485:2016)
◾ 11. EN ISO 14160:2021“保健产品的灭菌 - 用于利用动物组织及其衍生物的一次性医疗器械的液体化学灭菌剂 - 医疗器械灭菌过程的表征、开发、验证和常规控制的要求” (ISO 14160:2020)
◾ 12. EN ISO 15223-1:2021“医疗器械 - 与制造商提供的信息一起使用的符号 - 第 1 部分:一般要求”(ISO 15223-1:2021)
◾13. EN ISO 17664-1:2021“医疗保健产品的加工——医疗器械制造商为加工医疗器械提供的信息——第 1 部分:关键和半关键医疗器械”(ISO 17664-1:2021)
◾14。 EN IEC 60601-2-83:2020“医疗电气设备 - 第 2-83 部分:家用光疗设备基本安全和基本性能的特殊要求”

根据欧盟委员会的官方通知,符合相关商定标准或在欧盟官方公报上公布的这些标准的部分设备应被视为符合这些标准适用的医疗器械法规的要求或其部分被视为。




 

The European Commission has recognized 9 harmonized standards from the International Organization for Standardization (ISO) and the International Electrical Commission (IEC) related to medical devices. These ISO and IEC documents are used unchanged like European standards EN ISO or EN IEC.

Manufacturers of the products who have already made products compliant with the relevant ISO/IEC standards and intend to supply them to the European Union can use certificates of conformity to meet the requirements of the European Medical Devices Regulation (MDR).

The approved standards cover a number of important topics including biological evaluation of medical devices, sterilization, aseptic processing, quality management systems and more.

The endorsement of 9 harmonized standards came shortly after the approval of 5 thematic standards recognized by the European Commission in July 2021. The total number of standards harmonized under the Medical Devices Regulation has thus reached 14. The full list is as follows:

Documents approved by Commission Implementing Regulation (EU) 2021/1182 of July 16, 2021:

  • 1. EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation”

  • 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)

  • 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)< /li>

  • 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)

  • 5. 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)

Documents approved by Commission Implementing Regulation (EU) 2022/6 of January 4, 2022:

  • 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)

  • 7. EN ISO 10993-12:2021 “Biological evaluation of medical devices - Part 12: Sample preparation and reference materials” (ISO 10993-12:2021)

  • 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)

  • 9. EN ISO 13408-6:2021 “Aseptic processing of health care products - Part 6: Isolator systems” (ISO 13408-6:2021)

  • 10. EN ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes” (ISO 13485:2016)

  • 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)

  • 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)

  • 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)

  • 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”

According to the official notice from the European Commission, devices complying with the relevant agreed standards or parts of these standards published in the Official Journal of the European Union should be considered to be compliant with the requirements of the Medical Devices Regulation to which these standards apply or parts thereof to be viewed as.


 


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