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                400-609-1580
                产品在进行化学性能研究时,某项化学性能(例如还原物质)出现异常,需如何进行评价?

                  当化学性能研究结果出现异常时,建议申请人评估异常的原因,综合评估医疗器械的安全性。例如涂覆涂层的导管类产品,涂层材料导致还原物质测试结果异常时,建议对不涂覆涂层的产品进行测试,确认其化学〖性能是否可接受,同时结合涂层材料的临床应用史及生物相容性数据,综合评价。

                  2017-11-02 14:30