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Medical laboratories—Practical guidance for the estimation of measurement uncertainty
Scope of Application：
This document provides guidelines for the assessment and expression of measurement uncertainty (MU) for quantitative results in medical laboratories. It is also applicable to the assessment of quantitative results obtained from point-of-care testing (POCT) systems that are near medical decision limits. Additionally, this document applies to the assessment of measurement uncertainty for results obtained from qualitative methods (nominal methods) that include measurement steps. In routine testing, it is not recommended to report the measurement uncertainty assessment results along with patient test results, but it should be provided when required. Note: Examples of the application of measurement uncertainty can be found in Appendix B.
Basic information
Standard No：GB/Z 43280-2023
Standard Name： 医学实验室 测量不确定度评定指南
English Name：Medical laboratories—Practical guidance for the estimation of measurement uncertainty
Standard Status：In force
Release Date：2023-11-27
Effective Date：2024-06-01
Language of Publication：Simplified Chinese
Publication Information
Number of pages：68
Number of words：130 K
Other Information
Technical Committees：National Technical Committee for Standardization of Clinical Laboratory Testing and In Vitro Diagnostic Systems (SAC/TC 136)
Proposed Unit：National Medical Products Administration
Application Dept：State Administration for Market Supervision and Administration, State Standardization Administration
