YY/T 1455-2016Guidelines for values assignment of catalytic activity concentrations of enzymes using reference measurement procedures and evaluation of uncertainty (English PDF)
应用参考测量程序对酶催化活性浓度赋值及其不确定度评定指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1455-2016 is the English-translated version of 应用参考测量程序对酶催化活性浓度赋值及其不确定度评定指南.
YY/T 1455-2016 is the Chinese pharmaceutical industry standard that gives the guidelines for assigning the catalytic activity concentration of an enzyme by a reference measurement procedure and for evaluating the uncertainty of the value assigned.
It sets out how the procedure is applied in the reference measurement of an in vitro diagnostic system, the conditions and the calibration it requires, the sources of uncertainty and their combination, and the way the assigned value and its uncertainty are reported by the laboratory. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1455-2016
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 symbols and abbreviations
- 4 assignment
- 4.1 Selection of reference measurement program
- 4.2 to establish traceability
- 4.3 Evaluation of reference measurement procedures
- 4.4 Laboratory internal quality control
- 4.5 Sample Measurements
- 5.1 Analysis of the sources of uncertainty
- 5.2 Establishment of measurement model
- 5.3 Evaluation of standard uncertainty
- 5.4 Calculation of synthetic standard uncertainty
- 5.5 Determination of expansion uncertainty
- Appendix A (informative) Enzyme reference measurement program information Table
- Appendix B (informative) Limits Information given in other documents or activities
- Appendix C (informative) LDH assignment process and uncertainty assessment method example
- Appendix D (informative) Using the sensitivity factor for LDH measurement uncertainty Example Reference
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the method of applying reference measurement procedures to assess the concentration of enzyme catalytically active concentrations and their uncertainties.
This standard applies to the reference measurement of the in vitro diagnostic system. The laboratory uses the reference measurement procedure to assign the enzyme activity to its concentration and its uncertainty Fixed assessment work.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 15000.3 Standard sample work (3) General principles and statistical methods for standard sample setting
YY/T 0638 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Accumulated Concentrations of Enzyme Concentration in Calibrated and Controlled Substances Metrological traceability
WS/T 403-2012 Clinical biochemical tests General project analysis Quality indicators
3 Symbols and abbreviations
3.1 Symbols
The following symbols apply to this document. U. Extended Uncertainty. Urel. relative expansion uncertainty. uc, rel. synthetic uncertainty. alpha1; alpha2. pre-selected adjustment value.
3.2 Abbreviations
The following abbreviations apply to this document. ALP. alkaline phosphatase (AlkalinePhosphatase) ALT. Alanine aminotransferase (AlanineAminotransferase) AMY. Amylase (alpha-amylase) AST. Aspartate aminotransferase (AspartateAminotransferase) BIPM. Bureau of International Statistics (BureauInternationaldesPoidsetMesures) CK. creatine kinase (CreatineKase)
CNAS. China National Accreditation Committee for Conformity Assessment (ChinaNationalAccreditationServiceforConformity Assessment CRM. Certified Reference Information (CertifiedReferenceMaterial) CV. coefficient of variation (CoefficientofVariance)
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 15000.3Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability
- YY/T 0638In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
- WS/T 403-2012Analytical performance standard for routine analytes in clinical chemistry
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Related Standards
GB/T 15000.3-2023 — Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability
YY/T 0638-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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