GB/T 21415-2025In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (English PDF)
体外诊断医疗器械 建立校准品、正确度控制物质和人体样品赋值的计量溯源性要求
Also coversGB/T21415-2025 + GBT21415-2025
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 29, 2025
Implementation date
March 1, 2026
Scope
GB/T 21415-2025 is the English-translated version of 体外诊断医疗器械 建立校准品、正确度控制物质和人体样品赋值的计量溯源性要求.
Results from in vitro diagnostic tests are only comparable between laboratories and over time if the values assigned to calibrators and control materials can be traced to a recognised reference. This document sets out requirements for establishing that metrological traceability for the values assigned to calibrators, trueness control materials and human samples used with in vitro diagnostic medical devices.
The primary readers are manufacturers of diagnostic reagents and calibrators, developers of reference materials, clinical laboratories that assign values to patient samples, and regulatory affairs staff who must document traceability in technical dossiers submitted to the authorities. External quality assessment providers and reference measurement laboratories will also find it relevant.
The standard was issued on 29 August 2025 and takes effect on 1 March 2026, replacing GB/T 21415-2008. It is a recommended national standard, so it is voluntary unless referenced by a regulation, registration requirement or contract. Companies whose quality systems still cite the 2008 edition should review their procedures against the new text.
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Document preview — GB/T 21415-2025
National Standard of the People's Republic of China
- ICS
- 11.100.10
- Classification
- C44
- Replacing
- GB/T 21415-2008
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
GB/T 21415-2025 is a recommended national standard (GB/T) of the People's Republic of China, issued on 29 August 2025 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 March 2026.
This edition replaces GB/T 21415-2008.
The document adopts an international standard (ISO or IEC).
It is under the responsibility of the National Medical Products Administration.
Classification: ICS 11.100.10; CCS C44.
1 Scope
Results from in vitro diagnostic tests are only comparable between laboratories and over time if the values assigned to calibrators and control materials can be traced to a recognised reference. This document sets out requirements for establishing that metrological traceability for the values assigned to calibrators, trueness control materials and human samples used with in vitro diagnostic medical devices.
The primary readers are manufacturers of diagnostic reagents and calibrators, developers of reference materials, clinical laboratories that assign values to patient samples, and regulatory affairs staff who must document traceability in technical dossiers submitted to the authorities. External quality assessment providers and reference measurement laboratories will also find it relevant.
The standard was issued on 29 August 2025 and takes effect on 1 March 2026, replacing GB/T 21415-2008. It is a recommended national standard, so it is voluntary unless referenced by a regulation, registration requirement or contract. Companies whose quality systems still cite the 2008 edition should review their procedures against the new text.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.
Referenced standards
Cited by
- YY/T 1958-202517-alpha-hydroxyprogesterone testing kit (labelled immunoassay)
- YY/T 1962-2025Aldosterone testing kit (chemiluminescent immunoassay)
- YY/T 1964-2025Tacrolimus testing kit
- YY/T 1969-2025Microalbumin testing kit (immunoturbidimetry)
- YY/T 1970-2025Lipoprotein-associated phospholipase A2 testing kit (chemiluminescent immunoassay)
- GB/T 44672-2024In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
Editions of GB/T 21415
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 21415-2025 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | current edition | Current |
| 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 | previous edition | In force until 1 March 2026 |
This page sells the current edition, GB/T 21415-2025. Earlier editions are listed for reference only.
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