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In vitro diagnostic reagent water system solutions

Time：2017-04-16 10:11:28

      In vitro diagnostic reagents that can be used alone or with the use of instruments, apparatus, equipment, or system combination, in disease prevention, diagnosis, treatment monitoring, prognosis observation, health condition evaluation and prediction of course of genetic diseases for in vitro detection reagent, kit, calibrator (matter), QC (compounds), the body sample (in various body fluids, cells, tissue sample). Part of a medical device..

      According to the level of product risk, the in vitro diagnostic reagents are divided into third categories, second categories, the first category of products。

      In vitro diagnostic reagent water system general reference YY/T1244-2014 in vitro diagnostic reagent water indicators, selection of water system should pay attention to the following points：

      1,The conductivity of the water produced (such as 0.1ms/cm2), YY/T1244-2014 in vitro diagnostic reagent water index.

      2(do not recommend the use of ozone disinfection measures can be chosen or pure steam)。

      3、Engineering implementation can refer to the Chinese version of GMP and the United States in the United States FDA standard pharmaceutical water description。

      4、Water system technology reference: pretreatment + two level RO, pretreatment + first level RO+EDI, pretreatment + two level RO+EDI. Shenzhen City Huitong Source Environmental Protection Technology Co., Ltd. in the medical device with purified water equipment and water for injection system has in-depth experience in the engineering construction, hope more and industry professionals to discuss and exchange。