GBT19973-2005医用器材的灭菌微生物学方法系列标准.pdf

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1、ICS11.080.01C46妇日中华人民共和国国家标准GB/T19973.1-2005/ISO11737-1:1995医疗器械的灭菌微生物学方法第1部分:产品上微生物总数的估计Sterilizationofmedicaldevices-Microbiologicalmethods-Part1:Estimationofpopulationofmicroorganismsonproducts(ISO11737-1:1995,IDT)2005-11-04发布2006-04-01实施中华人民共和国国家质量监督检验检疫总局发布中国国家标准化管理委员会GB/T19973.1-2005/1S0

2、11737-1:1995目次前言，··，··················，····································，············································。··········一}引言············，···········，，，···········，··········，····················································，，，···‘··一且1范围······························，············

3、·································································⋯⋯12规范性引用文件················，·······················，，·········，，··········，··········，·······.·.........⋯⋯13术语和定义···，·····················································，，·········，，·························，·，···⋯⋯14总则·········

4、·······························································································，······⋯⋯25产品单元的选择。····················。，···，，···，·······，·，，·····，，，·······，，，，⋯⋯，，，..⋯⋯，.36技术的选择····································································，·······················，········

5、⋯⋯37技术选择·····························································，····，·················，，····，··············⋯⋯38技术的使用··································································································⋯⋯4附录A(资料性附录)产品上微生物总量的估计指南·······································，，··，····

6、···⋯⋯5附录B(资料性附录)微生物学技术确认方法指南············，·············。···························一14附录C(资料性附录)参考文献·............................................................⋯⋯，，..⋯⋯，，17GB/T19973.1-2005/ISO11737-1:1995月U舀GB/T工9973《医疗器械的灭菌微生物学方法》分为以下几个部分:第1部分:产品上微生物总数的估计;第2部分:确认灭菌程序的无菌试验。另外部分将在以后公布。本部分等同采用IS

7、O11737-1:1995《医疗器械的灭菌—微生物学方法—第1部分:产品上微生物总数的估计》由于GB/T19001-1994和GB/T19002-1994两份标准已经由GB/T19001-2000代替，所以本部分做了相应改动。本部分的附录A、附录B是资料性附录。本部分由国家食品药品监督管理局提出。本部分由全国消毒技术与设备标准化技术委员会归口。本部分主要起草单位:上海环境微生物控制工程研究所、上海市消毒品协会、济南医疗器械检测中心、广东省医疗器械质量监督检验所。本部分