iso13485生物兼容性试验控制程序3.doc

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1、生物兼容性试验控制程序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、                                                                                                                       2、范围                                                                                                                               

3、          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。                   

4、                                                                                                                          3、职责                                                                                                                            

5、             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                 

6、                                                                                                                    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。                                                                                                   

7、                                                  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。    

8、              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