GB/T 21919-2022 (English Version) PDF

Standard No.: GB/T 21919-2022
Language: Chinese, Available in English version
Release Date: 2022
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 21919-2022
Replace: GB/T 21919-2008

Scope: This document specifies the competency requirements for medical calibration laboratories to operate reference measurement procedures. This document takes the requirements of GB/T 27025-2019 as a normative reference, and lists additional requirements for calibration laboratories to fully perform their tasks. The relationship between this document and the provisions of GB/T27025-2019 is summarized in Appendix A. This document does not cover measurements of properties that report results on a nominal or ordinal scale. This document is not intended for use in medical laboratories. NOTE: ISO 15189 specifies the requirements for medical laboratories.

GB/T 21919-2022 Referenced Document

GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories
ISO 15193 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 15194 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO/IEC GUIDE 98-3 Uncertainty of measurement - Guide to the expression of uncertainty in measurement (GUM:1995). Extension to any number of output quantities
ISO/IEC GUIDE 99

2022 GB/T 21919-2022 Laboratory medicine—Requirements for the competence of calibration laboratories using reference measurement procedures
2008 GB/T 21919-2008 Laboratory medicine.Requirements for reference measurement laboratories