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1、ICS11.080C47中華人民共和國醫(yī)藥行業(yè)標(biāo)準(zhǔn)YY/T0567.1-2005/ISO13408-1:1998醫(yī)療產(chǎn)品的無菌加工第1部分:通用要求Asepticprocessingofhealthcareproducts-Part1:Generalrequirements(ISO13408-1:1998,IDT)2005-04-05發(fā)布2006-01-01實(shí)施.www.bzxzk.com國家食品藥品監(jiān)督管理局發(fā)布.YY/T0567.1-2005/ISO13408-1:1998目次前言·······················································
2、···························································??皿引言··················································································································??N1范圍··，············································································································??12術(shù)
3、語和定義·································································································....??13質(zhì)量管理體系····························································...............................·......??44人員·················································································
4、······························??55設(shè)施設(shè)計(jì)·········································································································??66無菌加工區(qū)(APA)··································································.·.........·.............??67無菌加工區(qū)以外的輔助區(qū)·····································
5、···············································??78環(huán)境空氣系統(tǒng)及其控制·······················································································??79更衣·······················································，···················································??810無菌加工區(qū)的清潔和消毒·······················
6、····························································??8n設(shè)備、公用設(shè)施的鑒定和過程確認(rèn)·································································??’·’“‘912傳遞至無菌區(qū)的材料和設(shè)備········································································??‘·“二‘二913加工時(shí)間···············································
7、···········································..··········??1014環(huán)境監(jiān)視規(guī)程························································································........??1015替戒線和措施線························
