1、目的


                                                                                                                                          


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


                                                                                                                                              


2、范圍


                                                                                                                                          


本程序規定了本公司無菌醫療器械產品做生物兼容性測試工作的管理職責、工作程序、內容和要求。


                                                                                                                                              


本程序適用于無菌醫療器械產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EN30993-1產品試驗項目分類的基本原則對產品進行分類。    


                                                                                                                                                  


4.2試驗項目的確定 


                                                                                                                                                  


4.2.1按接觸性質分類：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，為短期接觸。



 


4.3基本評價試驗方法選用按EN30993-1第6.2條執行。      


                                                                                                                        


4.4取樣送檢                                                                                                                                                          


質檢部按照試驗項目的要求，抽取同一滅菌批的產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所有產品的生物兼容性報告資料由質檢部統一歸檔保存，其保存期限為最后一批產品出廠


后五年。


                                                                                                                                            


5、相關文件     


                                                                                                                                  


5.1醫療器械生物學評價第1部分：試驗選擇指南  EN30993-1。


                                                                                                                                                         


5.2醫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。