Solution

Solution of purified water system for third types of medical equipment

Date：2015-03-10

      The first type of medical equipment is a medical device which is sufficient to ensure its safety and effectiveness by conventional management。

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

      Third types of medical devices are referred to, implanted in the human body; used to support and sustain life; the human body has the potential danger, the safety and effectiveness of medical devices must be strictly controlled。

Third types of medical equipment cleaning and disinfection, directly related to the safety and reliability of the product, so the choice of water system should pay attention to the following points,

1、The conductivity of the water produced, such as less than or equal to 1.3uc/cm2 and necessary reference of Chinese Pharmacopoeia 2010 edition or the United States \ USP35-NF30 USP32-NF27 injection 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、Process reference: pretreatment + two stage RO, pretreatment + two stage RO+EDI, pretreatment + two stage RO+ multi effect distilled water machine (typical process of water injection). 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.