ISO 14971:2019 醫療器材風險管理標準已正式發行

『ISO 14971:2019 醫療器材風險管理』(ISO 14971:2019 Medical devices - Application of risk management to medical devices)國際標準已於2019年12月正式發行。

ISO 14791:2019 (第三版) 與ISO 14971: 2007 (第二版)相較，有以下的不同：

1. 增加專有名詞” benefit” 的定義。

2. 增加專有名詞” reasonably foreseeable misuse” 的定義。

3 增加專有名詞” state of the art” 的定義。

4. 將” Qualification of personnel” 修改為” Competence of personnel”。

5. 將第二版，章節4.2 “Intended use and identification of characteristics related to the safety of the medical device” 分拆至章節5.2 ” Intended use and reasonably foreseeable misuse” 及章節5.3 “Identification of characteristics related to safety”。

6. 將第二版，章節8 ” Risk management report” 修改為” Risk management review”。

7. 將第二版，章節9 “Production and post-production information” 改編為章節10 Production and post-production activities; 章節10.1 General; 章節10.2 Information collection; 章節10.3 Information review; 章節10.4 Actions

8. 將第二版Annex C Questions that can be used to identify medical device characteristics that could impact on safety搬移至ISO/TR 24971

9. 將第二版Annex D Risk concepts applied to medical devices搬移至ISO/TR 24971

10. 將第二版Annex E Examples of hazards, foreseeable sequences of events and hazardous situations修改為Annex C Fundamental risk concepts

11. 將第二版Annex F Risk management plan搬移至ISO/TR 24971

12. 將第二版Annex G Information on risk management techniques搬移至ISO/TR 24971

13. 將第二版Annex H Guidance on risk management for in vitro diagnostic medical devices搬移至ISO/TR 24971

14. 將第二版Annex I Guidance on risk analysis process for biological hazards予以刪除。

15. 將第二版Annex J Information for safety and information about residual risk搬移至ISO/TR 24971