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                血液浓缩器如何选择典型性产品进行检测?

                  典型性产品选择包含全部原材料和组件、结◆构最复杂、风险最高、使用性能可以覆盖本注册单元其他型号的产品,进行全项目注册检测。同一注册单元产品,建议至少对膜面积最大的型号进行全项目检测,同时再检测膜面积最小型号的物理性能。所有组件均应进行注册检测,特别是具有特殊结构、性能的组件。完成典型性产品检测后,同一注册单元其他型号可进行差异性检测。

                  审评⌒ 五部供稿

                  2018-08-03 09:00