GB/T 19702-2005体外诊断医疗器械生物源性样品中量的测量　参考测量程序的说明.pdf

ICS 11.040 C 30 中 华 人 民 共 和 国 国 家 标 准 GB/T 19702-2005/ISO 15193:2002 体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的说明 Invitrodiagnosticmedicaldevices- Measurementofquantitiesinsamplesofbiologicalorigin- Presentationofreferencemeasurementprocedures (ISO15193:2002,IDT) 2005-03-23发布 2005-12-01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 19702-2005/ISO 15193:2002 目 次 前言 ·············。································································································… … 工 引言 ·········································································································，·······…… n 1 范围 ······························································，·········································，······…… 1 2 规范性引用文件 ·······························································································…… 1 3 术语和定义 ··········、···························，·······························································…… 1 4 参考测量程序的说明 ························································································…·…2 4.1书面参考测量程序的要素 ························，··················································…·…“2 4.2 警告和安全性注意事项 ·······，·····································，，···········，·········，···············一· 3 4.3 弓}b ···········································································································…‘… 4 4.4 范围 ，· ·，····，··，，，， ··· ·，，·，····· ····· ，，，···，，，， ······，，····， ，，，，二4 4.5 术语 ·····，························，，··················，··················，，····································…… 4 4.6 测量原理和方法 ············。································，·····································