GB/T 19973.1-2005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.pdf

ICS 11.080.01 C 46 妇日 中 华 人 民 共 和 国 国 家 标 准 GB/T 19973.1-2005/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 (ISO 11737-1:1995,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/T 19973.1-2005/1S0 11737-1:1995 目 次 前言 ，··，··················，····································，············································。··········一 } 引言 ············，···········，，，···········，··········，····················································，，，···‘·一· 且 1 范围 ······························，·············································································…… 1 2 规范性引用文件 ················，·······················，，·········，，··········，··········，······.·.·…… 1 3 术语和定义 ···，·····················································，，·········，，·························，·，···…… 1 4 总则 ········································································································，······…… 2 5 产品单元的选择 。····················。，···，，·· ·，······ ·，·，，·····，，，·······，，，，…… ，，，..…… ，.3 6 技术的选择 ····································································，·······················，········…… 3 7 技术选择 ·····························································，····，·················，，····，··············…… 3 8 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 ············，··············。··························一· 14 附录C(资料性附录)参考文献 .·……，，..……，，17