GB/T 19972-2005医疗保健产品灭菌　生物指示物　选择、使用及检验结果判断指南.pdf

ICS 11.080.99 C 47 巧旨 中 华 人 民 共 和 国 国 家 标 准 GB/T19972-2005/1S014161:2000 医疗保健产品灭菌 生物指示物 选择、使用及检验结果判断指南 Sterilizationofhealthcareproducts- Biologicalindicators- Guidancefortheselection,useandinterpretationofresults (ISO14161:2000,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/T19972-2005/ISO 14161:2000 目 次 月U舀 ’”‘““’。““““····，························。··························································。···… … 班 引言 ··，···············································································································…… IV 1 范围 ·····································································································，·，······…… 1 2 规范性引用文件 .·，······································……，·····.·…… 1 3 术语和定义 ····································································································…… 1 4 总则 ·················，···········································，··················································一· 3 5 生物指示物特性 ····················································································.··……，，.4 6 供应商的选择 ···································································································…… 6 7 工艺设定中的生物指示物 ·················，········，········································……，…… 8 8 灭菌确认中的生物指示物 ···························，························…·…，.，，……9 9 日常监测中的生物指示物 ···················································…… ，……，…… 11 10 结果 ·································································································