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- 已被新标准代替,建议下载标准 GB/T 19972-2018
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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 ·································································································
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