Solution of purified water system for second types of medical equipment

                      Time:2017-04-16 10:16:13

                            Second types of medical devices are the medical devices that should be controlled for their safety and effectiveness.

                            Second types of medical equipment water system generally refer to the 2015 edition of the Chinese Pharmacopoeia purified water standard implementation (specific look at the registration certificate classification)。

                            Selection of water system should pay attention to the following points:

                            1,The conductivity of the water produced (such as 2us/cm2), when necessary, refer to 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。