1、目的


                                                                                                                                          


為了確定每一種醫療器械對其預期用途的適宜性,應對其安全性,包括風險的可接受性作出分析和判斷，使其降低到患者或使用者可接受水平。


                                                                                                                                                                              


2、適用范圍


                                                                                                                                          


本程序規定對產品進行風險分析報告的職責、工作程序、內容和要求。


                                                                                                                                                                              


                                                                                                                                                                              


3、職責


                                                                                                                                          


3.1技術部負責編制風險分析報告程序。


                                                                                                                                                            


3.2技術部負責編寫、審定、保存不同型號產品的風險分析報告。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1對產品進行定性或定量的描述，包括以下內容：                                                                                                                                            


a)產品的預期用途及使用方法；                                                                                                                                         


b)有關在器械中所使用的材料/元件的風險；                                                                                                                                               


c)判定是否預期與病人和第三者的接觸；                                                                                                                                              


d)是否有物質進入病人體內或由病人抽取；


e)是否以無菌形式提供或由用戶滅菌或采用其它微生物控制處理方法；                                                                                                                            


f)產品是否用以控制其他藥物與之相互起作用；                                                                                                                                            


g)產品是否有限定的有效期；                                                                                                                                           


h)產品預定是一次性使用還是可以重復使用。


                  


4.2對產品可能造成傷害的潛在源，一般涉及以下方面：


                  


4.2.1 生物學危害：                                                                                                                                                   


a）生物污染；


b）生物不相容性；


c）毒性；                                                                                                                                                  


d）過敏性；


e）交叉感染；                                                                                                                                              


f）致熱性。


                                                                                                                                  


4.2.2 環境危害：因廢物或器械處置的污染；


                                                                                                                                                            


4.2.3 使用的危害： 



 


                                                                                                                                                


a)不適當的標簽；                                                                                                                                           


b)一次性使用醫療器械的很可能再次使用的危害性警告不當；                                                                                                                                   


c)不適當的使用前檢查說明書；


                                                                                                                                  


4.2.4 功能失效、維護及老化引起的危害：                                                                                                                                                   


a)與預期用途不相適應的性能特征。                                                                                                                                                  


b)不適當的重復使用。                                                                                                                                                 


c)缺乏適當的壽命終止規定。                                                                                                                                           


d)不適當的包裝及存放環境。


                                                                                                                                  


4.3對每項危害的風險估計



 


4.3.1 利用可得到的有效數據/資料、 相關標準、醫學證明、適當的調查結果，評估在正常


和失效兩種狀態下的所有風險。


                                                                                                                            


4.3.2 評估時可采用定量或定性的方法進行,根據需要可選用失效模式和效應分析、故障樹分


析及危害和可操作性研究。


                                                                                                                                            


4.4風險評審


                                                                                                                                                            


4.4.1 經過對危害的風險評估，確定其是否在可接受的水平。



 


4.4.2 若某項危害風險超出了可接受水平，則應對此項危害采取措施，降低風險。



 


4.4.3 若危害僅在故障發生時才超出可接受水平，則應說明：


a)危害發生前，使用者能否發現故障；                                                                                                                                                


b)故障能否通過生產控制或預防性維護消除；                                                                                                                                              


c)誤用能否導致故障；                                                                                                                                                 


d)能否增加報警。



 


4.5風險降低


                                                                                                                                                            


為降低風險至可接受水平，可采取以下措施：