GBT19973.1-2005 医用器材的灭菌 微生物学方法 第一部分：产H口H上微生物总数的估计.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

2、验检疫总局发布中国国家标准化管理委员会GB/T19973.1-2005/1S011737-1:1995目次前言，··，··················，····································，············································。··········一}引言············，···········，，，···········，··········，·······························

3、·····················，，，···‘··一且1范围······························，·············································································⋯⋯12规范性引用文件················，·······················，，·········，，··········，··········，·······.·.........⋯⋯13术语和定

4、义···，·····················································，，·········，，·························，·，···⋯⋯14总则········································································································，······⋯⋯25产品单元的选择。····················。，··

5、·，，···，·······，·，，·····，，，·······，，，，⋯⋯，，，..⋯⋯，.36技术的选择····································································，·······················，········⋯⋯37技术选择·····························································，····，·················，，····，

6、··············⋯⋯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·······································，，··，·······⋯⋯5附录B(资料性附录)微生物学技术确认方法指南············，··············。····

7、·······················一14附录C(资料性附录)参考文献·............................................................⋯⋯，，..⋯⋯，，17标准分享网www.bzfxw.com免费下载GB/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

8、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》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