YY/T 1174-2010Semi-automatic chemiluminescence immunoassay analyzer (English PDF)
半自动化学发光免疫分析仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY/T 1174-2010 is the English-translated version of 半自动化学发光免疫分析仪.
YY/T 1174-2010 is the Chinese pharmaceutical industry standard for the semi-automatic chemiluminescence immunoassay analyzer.
It specifies the requirements, the test methods, the marking, the labelling and the instructions and the rules for packaging, transport and storage, covering the detection limit and the linearity of the luminescence measurement, the accuracy and the repeatability, the cross-talk between wells, the stability of the optical system and the electrical safety. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY/T 1174-2010
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
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is evaluated semi-automatic chemiluminescence immunoassay analyzer based on product quality.
1 Scope
This standard specifies the semi-automatic chemiluminescence immunoassay analyzer requirements, test methods, marking, labeling and instructions, packaging, transport and Storage.
This standard applies to semi-automatic chemiluminescence immunoassay analyzer (hereinafter referred to as the analyzer) detector portion.
This standard does not apply to other parts of the analyzer incubation, washing, loading and so on.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1-2007 measurement, control and laboratory use safety requirements for electrical equipment - Part 1. General requirements
GB/T 14710 medical electrical environmental requirements and test methods
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 CLIA chemiluminescenceimmunoassay
It is a chemiluminescent immunoassay and combine technology, a series of immune response by an antigen or antibody labeled with the analytes, Finally, to determine the luminous intensity derived analyte content.
3.2 Chemiluminescence immunoassay analyzer
Chemiluminescence immunoassay as a basic principle, the use photoelectric detection technology, qualitative and (or) quantitative detection of the immune analyzer.
3.3 Manual or otherwise finished adding
the sample, add reagents, mixing, washing, incubation and other parts or all of the work, and then automatically by the instrument Testing, calculation, report the results of chemiluminescence immunoassay analyzer.
4 Requirements
4.1 Metering Repeatability
The coefficient of variation of the photometric value CV<=2%.
4.2 Photometry value stability
Relatively poor representation should be <=3%.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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YY/T 1174-2010
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