1、目的


                                                                                                                                          


為保證無菌醫(yī)療器械產(chǎn)品和材料滿足歐盟《醫(yī)療器械指令》93/42/EEC的要求，對帶有CE標志的無菌醫(yī)療器械產(chǎn)品進行生物兼容性測試，確保產(chǎn)品使用的安全性。


                                                                                                                                              


2、范圍


                                                                                                                                          


本程序規(guī)定了本公司無菌醫(yī)療器械產(chǎn)品做生物兼容性測試工作的管理職責、工作程序、內(nèi)容和要求。


                                                                                                                                              


本程序適用于無菌醫(yī)療器械產(chǎn)品生物兼容性測試以及生物兼容性測試報告的編制。


                                                                                                                                              


3、職責


                                                                                                                                          


3.1技術部負責對產(chǎn)品做生物兼容性試驗的分類和測試標準及其它技術文件的準備工作。



 


3.2質(zhì)檢部負責送樣測試和編制、保存生物兼容性測試報告。 


                                                                                                                                                  


4、控制程序     


                                                                                                                                  


4.1依據(jù)EN30993-1產(chǎn)品試驗項目分類的基本原則對產(chǎn)品進行分類。    


                                                                                                                                                  


4.2試驗項目的確定 


                                                                                                                                                  


4.2.1按接觸性質(zhì)分類：應做細胞毒性、致敏、皮膚刺激性、毒性、血液相容性試驗。


                  


4.2.2按接觸時間分類：使用時間在24h以內(nèi)，為短期接觸。



 


4.3基本評價試驗方法選用按EN30993-1第6.2條執(zhí)行。      


                                                                                                                        


4.4取樣送檢                                                                                                                                                          


質(zhì)檢部按照試驗項目的要求，抽取同一滅菌批的產(chǎn)品委托法定的實驗部門進行試驗。



 


4.5在完成了所有的試驗項目以后，質(zhì)檢部負責按試驗報告編制生物兼容性測試報告，并進行


生物學評價。      



 


4.6所有產(chǎn)品的生物兼容性報告資料由質(zhì)檢部統(tǒng)一歸檔保存，其保存期限為最后一批產(chǎn)品出廠


后五年。


                                                                                                                                            


5、相關文件     


                                                                                                                                  


5.1醫(yī)療器械生物學評價第1部分：試驗選擇指南  EN30993-1。


                                                                                                                                                         


5.2醫(yī)用輸液輸血注射器具檢驗方法第2部分生物試驗方法GB/T14233.2。         


                                                                                                                                                  


6、相關記錄


                                                                                                                                          


6.1細胞毒性試驗； 


                                                                                                                                                  


6.2致敏性試驗；


                                                                                                                                                            


6.3皮內(nèi)刺激性試驗；        


                                                                                                                                                  


6.4急性毒性試驗； 


                                                                                                                                                  


6.5溶血性試驗；   


                                                                                                                                                  


6.6生物兼容性測試報告。