现行 YY/T 0638-2008
体外诊断医疗器械 生物样品中量的测量 校准品和控制物质中酶催化浓度赋值的计量学溯源性 体外诊断医疗器械 生物样品中量的测量 校准品和控制物质中酶催化浓度赋值的计量学溯源性 In vitro diagnostic medical devices -Measurement of quantities in biological samples - Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
发布日期:2008-04-25
实施日期:2009-06-01
分类信息
研制信息

归口单位: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)

起草单位: 北京市医疗器械检验所、 罗氏诊断产品(上海)有限公司

起草人: 胡冬梅、 冯仁丰、 黄柏兴、 张新梅、 王瑞霞、 贺学英

标准简介

本标准规定了确保酶催化浓度校准品和控制物质赋值的计量学溯源性的方法。这些校准品和控制物质预期用于建立或验证酶催化浓度测量的正确度,由制造商提供,作为体外诊断医疗器械的一部分或与其组合使用。本标准不适用于:a)对参考测量程序设计或选择的要求;b)酶质量或酶免疫反应性涉及的量;c)无赋值、仅用于评价测量程序精密度,即重复性或重现性的控制物质(精密度控制物质);d)预期用于室内质量控制的控制物质,此类物质具有建议的可接受结果值区间,此区间由不同实验室针对某一规定测量程序协议制定,其限值不具计91,HG/T 2458,中华人民共和国食品卫生法(1995年)

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最后更新时间 2025-08-31