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2022.1.6，歐盟委員會公布Commission Implementing Decision (EU) 2022/15，正式承認了另外5個關于體外診斷的協(xié)調標準，以滿足IVDR要求。

這些標準包括滅菌、無菌處理、質量管理體系、產品信息中符號的使用以及建立校準品、質控品和人體樣本某些值的計量可追溯性的要求。

加上2021年7月份Commission Implementing Decision (EU) 2021/1195公布的IVDR的4個協(xié)調標準（都是滅菌相關的），使得目前IVDR協(xié)調標準總數達到9個。

Commission Implementing Decision (EU) 2021/1195下公布的4個IVDR協(xié)調標準：

1. EN ISO 11135:2014/A1:2019

Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices 

2. EN ISO 11137-1:2015/A2:2019

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 

3. 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 

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 

Commission Implementing Decision (EU) 2022/15下公布的5個IVDR協(xié)調標準：

5. EN ISO 11737-1:2018/A1:2021

Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products 

6. EN ISO 13408-6:2021

Aseptic processing of health care products – Part 6: Isolator systems 

7. EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes 

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)

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