First, since the statute does not make clear provisions on non-standard blades, then this issue is a conventional approach. In fact, it should be said not to be the conventional. Because of the regulatory provisions of the IVD quality Management system Many of the previous medicines are used in some normative practices. In the pharmaceutical GMP2010 version of the Implementation Guide, the production area of non-standard blade cleaning is stipulated in the production environment in accordance with the conditions of cleaning. Second, we look at the provisions of other medical device products: In the medical device production Quality Management Standard aseptic appendix (2015 101th Bulletin) Such provisions: non-standard blade washing: drying room, sanitary ware, special workstation cleaning treatment and disinfection of the area of the end of the air cleanliness level can be lower than the production area of one level, but not less than 300,000 level. The storage of sterile non-standard blades should be arranged in the 10,000 level clean room (area).
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