GB/T 21919-2022Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (English PDF)
检验医学 运行参考测量程序的校准实验室的能力要求
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
October 14, 2022
Implementation date
May 1, 2023
Scope
GB/T 21919-2022 is the English-translated version of 检验医学 运行参考测量程序的校准实验室的能力要求.
GB/T 21919-2022 is the Chinese standard "Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures".
Its scope clause reads: This document specifies requirements for the competence of medical calibration laboratories to run reference measurement procedures. This document is based on the requirements of GB/T 27025-2019 This is a normative reference listing additional requirements for calibration laboratories to adequately perform their tasks.
The relationship between this document and the provisions of GB/T 27025-2019 is summarized in Appendix A. This document does not include 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.
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Document preview — GB/T 21919-2022
National Standard of the People's Republic of China
- ICS
- 11.100.99
- Classification
- C 30
- Replacing
- GB/T 21919-2008
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General Requirements
- 5 Structural Requirements
- 6 Resource Requirements
- 6.1 General
- 6.2 Personnel
- 6.3 Laboratory Facilities and Environmental Conditions
- 6.4 Device
- 6.5 Metrological traceability
- 6.6 Reference substances
- 6.7 Externally provided products and services
- 7 Process Requirements
- 7.1 Review of Requirements, Tenders and Contracts
- 7.2 Reference measurement procedure
- 7.3 Sample processing
- 7.4 Measurement record
- 7.5 Evaluation of measurement uncertainty
- 7.6 Ensuring the validity of the measurement results
- 7.7 Reporting measurement results
- 8 Management Requirements
- 8.1 General
- 8.2 Internal Audit
- Appendix A (Informative) Relationship between this document and GB/T 27025-20
1 Scope
This document specifies requirements for the competence of medical calibration laboratories to run reference measurement procedures. This document is based on the requirements of GB/T 27025-2019
This is a normative reference listing additional requirements for calibration laboratories to adequately perform their tasks.
The relationship between this document and the provisions of GB/T 27025-2019 is summarized in Appendix A.
This document does not include 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.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories (ISO /IEC 17025.2017, IDT)
ISO /IEC Guide 98-3 Measurement Uncertainty Part 3.Guidelines for the Expression of Measurement Uncertainty [Uncertaintyofmea-
Note. GB/T 27418-2017 Evaluation and representation of measurement uncertainty (ISO /IEC Guide98-3.2008, MOD)
ISO 15193 Requirements for the presentation and content of reference measurement procedures for the measurement of quantities in samples of biological origin for in vitro diagnostic medical devices
Note. GB/T 19702-2021 Requirements for the expression and content of reference measurement procedures for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices (ISO 15193.2009, IDT)
ISO 15194 Measurement of quantities in biologically derived samples of in vitro diagnostic medical devices Certified reference materials and requirements for the content of supporting documents
Note. GB/T 19703-2020 Requirements for the content of certified reference materials and supporting documents for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices (ISO 15194.2009, IDT)
ISO 17511 Requirements for in vitro diagnostic medical devices to establish traceability of calibrators, correctness control substances and human sample assignments
Note. GB/T 21415-2008 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices (ISO 17511.2003, IDT)
ISO 18153 Enzyme-catalyzed concentration of calibrators and control substances for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices
GB/T 16886.6 | GB/T 16886.9 | GB/T 19702 | GB/T 22576.1 | GB/T 16886.2 | […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 27025-2019General requirements for the competence of testing and calibration laboratories
- GB/T 27418-2017Guide to the evaluation and expression of uncertainty in measurement
- GB/T 19702-2021In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
- GB/T 19703-2020In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content
- GB/T 21415-2008In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
IEC 17025.2017 · ISO 15193 · ISO 15193.2009 · ISO 15194 · ISO 15194.2009 · ISO 17511 · ISO 17511.2003 · ISO 18153
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Related Standards
GB/T 19702-2021 — In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
GB/T 19703-2020 — In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
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