GB/Z 43280-2023 Active National standards

GB/Z 43280-2023 Medical laboratories—Practical guidance for the estimation of measurement uncertainty

Publish Date: 2023-11-27 Implement Date: 2024-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/Z 43280-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2023-11-27

Implement Date: 2024-06-01

Pages: 66 pages

Scope

This document provides guidelines for assessing and expressing the measurement uncertainty (MU) of quantitative results in medical laboratories, and is also applicable to the assessment of quantitative results obtained by point-of-care testing (POCT) systems that are close to the medical decision limit. This document is also applicable to the assessment of measurement uncertainty for results obtained by qualitative methods (naming) that include measurement steps. In daily testing, it is not recommended to report the results of measurement uncertainty assessment together with patient test results, but it should be provided when necessary. Note: Examples of measurement uncertainty applications are provided in Appendix B.