1、目的


                                                                                                                                          


为保证无菌医疗器械产品和材料满足欧盟《医疗器械指令》93/42/EEC的要求，对带有CE标志的无菌医疗器械产品进行生物兼容性测试，确保产品使用的安全性。


                                                                                                                                              


2、范围


                                                                                                                                          


本程序规定了本公司无菌医疗器械产品做生物兼容性测试工作的管理职责、工作程序、内容和要求。


                                                                                                                                              


本程序适用于无菌医疗器械产品生物兼容性测试以及生物兼容性测试报告的编制。


                                                                                                                                              


3、职责


                                                                                                                                          


3.1技术部负责对产品做生物兼容性试验的分类和测试标准及其它技术文件的准备工作。



 


3.2质检部负责送样测试和编制、保存生物兼容性测试报告。 


                                                                                                                                                  


4、控制程序     


                                                                                                                                  


4.1依据EN30993-1产品试验项目分类的基本原则对产品进行分类。    


                                                                                                                                                  


4.2试验项目的确定 


                                                                                                                                                  


4.2.1按接触性质分类：应做细胞毒性、致敏、皮肤刺激性、毒性、血液相容性试验。


                  


4.2.2按接触时间分类：使用时间在24h以内，为短期接触。



 


4.3基本评价试验方法选用按EN30993-1第6.2条执行。      


                                                                                                                        


4.4取样送检                                                                                                                                                          


质检部按照试验项目的要求，抽取同一灭菌批的产品委托法定的实验部门进行试验。



 


4.5在完成了所有的试验项目以后，质检部负责按试验报告编制生物兼容性测试报告，并进行


生物学评价。      



 


4.6所有产品的生物兼容性报告资料由质检部统一归档保存，其保存期限为最后一批产品出厂


后五年。


                                                                                                                                            


5、相关文件     


                                                                                                                                  


5.1医疗器械生物学评价第1部分：试验选择指南  EN30993-1。


                                                                                                                                                         


5.2医用输液输血注射器具检验方法第2部分生物试验方法GB/T14233.2。         


                                                                                                                                                  


6、相关记录


                                                                                                                                          


6.1细胞毒性试验； 


                                                                                                                                                  


6.2致敏性试验；


                                                                                                                                                            


6.3皮内刺激性试验；        


                                                                                                                                                  


6.4急性毒性试验； 


                                                                                                                                                  


6.5溶血性试验；   


                                                                                                                                                  


6.6生物兼容性测试报告。