ISO/TS 20914:2019 医学实验室 测量不确定度估计的实用指南

标准编号:ISO/TS 20914:2019

中文名称:医学实验室 测量不确定度估计的实用指南

英文名称:Medical laboratories — Practical guidance for the estimation of measurement uncertainty

发布日期:2019-07

标准范围

本文件为医学实验室产生的定量测量值的测量不确定度(MU)的估计和表示提供了实用指南。该范围还包括护理点测试系统在医疗决策阈值附近产生的定量测量值。本文件还适用于包括测量步骤的定性(标称)方法产生的结果的MU估计。不建议将MU的估计值与患者测试结果一起定期报告,但应根据要求提供。注:MU的应用示例见附录B。

This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request.NOTE See Annex B for an example of application of the MU.

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