YY/T 1228-2014Albumin test reagent kit (English PDF)
白蛋白测定试剂（盒）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1228-2014 is the English-translated version of 白蛋白测定试剂（盒）.
YY/T 1228-2014 is the Chinese pharmaceutical industry standard for the albumin test reagent kit.
It specifies the requirements, the test methods, the labels, the instructions for use and the rules for packaging, transport and storage, covering the appearance, the blank absorbance, the traceability of the calibrator, the accuracy, the linear range, the precision, the interference and the stability.
It applies to kits that determine albumin quantitatively in serum, plasma and other body fluids by the bromocresol green or the bromocresol purple method. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1228-2014
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 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the albumin assay reagent (kit) requirements, test methods, labels, brochures, packaging, transportation and storage.
This standard applies to measuring albumin using bromocresol green method, bromocresol purple method for serum, plasma and other body fluids quantitative detection of albumin Given reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used. This standard does not apply to dry chemical assay reagents.
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 3100 International System of Units and Its Application
YY/T 0316 Medical Devices Risk Management for Medical Device Applications Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 Appearance
In line with the provisions of the company's normal appearance requirements.
3.2 PACKING
Not less than the indicated value.
3.3 Reagent blank absorbance
Producers meet the requirements specified.
3.4 Sensitivity Analysis
Producers meet the requirements specified.
3.5 Linear Interval
Serum samples were tested in a linear reagent [10.0,60.0] g/L range.
a) The linear correlation coefficient ︱r︱ not less than 0.990;
b) within [10.0,20.0] g/L range, linearity deviation should be ± 4.0g/L within the range;
[20.1,60.0] in the g/L range, linearity deviation should not exceed ± 10.0%.
3.6 Precision
3.6.1 Repeatability
Repeat the test concentrations (40 ± 5) g/L of serum control, the results of the repeatability (coefficient of variation, CV) should not exceed 2.0%.
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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
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Related Standards
GB 3100-1993 — SI units and recommendations for the use of their multiples and of certain other units
YY/T 0316-2003 — Medical devices - Application of risk management to medical devices
YY/T 0316-2008 — Medical devices - Application of risk management to medical devices
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YY/T 1228-2014
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