1、目的


                                                                                                                                          


為保證無(wú)菌醫(yī)療器械產(chǎn)品和材料滿(mǎn)足歐盟《醫(yī)療器械指令》93/42/EEC的要求，對(duì)帶有CE標(biāo)志的無(wú)菌醫(yī)療器械產(chǎn)品進(jìn)行生物兼容性測(cè)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(wú)菌醫(yī)療器械產(chǎn)品做生物兼容性測(cè)試工作的管理職責(zé)、工作程序、內(nèi)容和要求。


                                                                                                                                              


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


                                                                                                                                              


3、職責(zé)


                                                                                                                                          


3.1技術(shù)部負(fù)責(zé)對(duì)產(chǎn)品做生物兼容性試驗(yàn)的分類(lèi)和測(cè)試標(biāo)準(zhǔn)及其它技術(shù)文件的準(zhǔn)備工作。



 


3.2質(zhì)檢部負(fù)責(zé)送樣測(cè)試和編制、保存生物兼容性測(cè)試報(bào)告。 


                                                                                                                                                  


4、控制程序     


                                                                                                                                  


4.1依據(jù)EN30993-1產(chǎn)品試驗(yàn)項(xiàng)目分類(lèi)的基本原則對(duì)產(chǎn)品進(jìn)行分類(lèi)。    


                                                                                                                                                  


4.2試驗(yàn)項(xiàng)目的確定 


                                                                                                                                                  


4.2.1按接觸性質(zhì)分類(lèi)：應(yīng)做細(xì)胞毒性、致敏、皮膚刺激性、毒性、血液相容性試驗(yàn)。


                  


4.2.2按接觸時(shí)間分類(lèi)：使用時(shí)間在24h以?xún)?nèi)，為短期接觸。



 


4.3基本評(píng)價(jià)試驗(yàn)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(yàn)項(xiàng)目的要求，抽取同一滅菌批的產(chǎn)品委托法定的實(shí)驗(yàn)部門(mén)進(jìn)行試驗(yàn)。



 


4.5在完成了所有的試驗(yàn)項(xiàng)目以后，質(zhì)檢部負(fù)責(zé)按試驗(yàn)報(bào)告編制生物兼容性測(cè)試報(bào)告，并進(jìn)行


生物學(xué)評(píng)價(jià)。      



 


4.6所有產(chǎn)品的生物兼容性報(bào)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(chǎng)


后五年。


                                                                                                                                            


5、相關(guān)文件     


                                                                                                                                  


5.1醫(yī)療器械生物學(xué)評(píng)價(jià)第1部分：試驗(yàn)選擇指南  EN30993-1。


                                                                                                                                                         


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


                                                                                                                                                  


6、相關(guān)記錄


                                                                                                                                          


6.1細(xì)胞毒性試驗(yàn)； 


                                                                                                                                                  


6.2致敏性試驗(yàn)；


                                                                                                                                                            


6.3皮內(nèi)刺激性試驗(yàn)；        


                                                                                                                                                  


6.4急性毒性試驗(yàn)； 


                                                                                                                                                  


6.5溶血性試驗(yàn)；   


                                                                                                                                                  


6.6生物兼容性測(cè)試報(bào)告。