ICS11.080C47中华人民共和国医药行业标准YY/T0567.1-2005/ISO13408-1:1998医疗产品的无菌加工第1部分:通用要求Asepticprocessingofhealthcareproducts-Part1:Generalrequirements(ISO13408-1:1998,IDT)2005-04-05发布2006-01-01实施国家食品药品监督管理局发布YY/T0567.1-2005/ISO13408-1:1998目次前言··················································································································⋯⋯皿引言··················································································································⋯⋯N1范围··，············································································································⋯⋯12术语和定义·································································································....⋯⋯13质量管理体系····························································...............................·......⋯⋯44人员···············································································································⋯⋯55设施设计·········································································································⋯⋯66无菌加工区(APA)··································································.·.........·........
