YY/T 1234-2014Alkaline phosphatase test reagent kit(Method of NPP-AMP) (English PDF)
碱性磷酸酶测定试剂（盒）（NPP底物-AMP缓冲液法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1234-2014 is the English-translated version of 碱性磷酸酶测定试剂（盒）（NPP底物-AMP缓冲液法）.
YY/T 1234-2014 is the Chinese pharmaceutical industry standard for the alkaline phosphatase assay reagent kit that uses the AMP buffer method with nitrophenyl phosphate as substrate.
It sets the technical requirements for the kit, the test methods, the labels, the instruction leaflet and the rules for packaging, transport and storage, the requirements covering appearance, the blank absorbance, the analytical sensitivity, linearity, precision, accuracy against a reference material and stability.
It applies to kits for the quantitative determination of alkaline phosphatase activity in serum or plasma, whether used manually or on a semi-automatic biochemical analyser, and not to dry-type kits. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1234-2014
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 alkaline phosphatase assay reagent (kit) technical requirements, test methods, labels, brochures, packaging, transport and Storage.
This standard applies to the determination of alkaline phosphatase using AMP buffer, serum or plasma alkaline phosphatase activity quantitative detection Reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used.
This standard does not apply to dry-type alkaline phosphatase assay reagent (kit).
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
GB/T 21415 calibrator measured in vitro diagnostic medical devices samples of biological origin and quality control measurement of the amount of material assigned school Traceability
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
YY/T 0638 in vitro diagnostic medical devices samples of biological origin quantity measurement calibration and quality control material for catalytic concentration of enzymes assigned Metrological traceability of values
3 Requirements
3.1 Appearance
In line with the provisions of the company's normal appearance requirements.
3.2 PACKING
Net content of the liquid reagent to be less than indicated value.
3.3 Reagent blank
3.3.1 Reagent blank absorbance
Reagent blank absorbance should be consistent with the company given range.
3.3.2 Reagent blank absorbance change rate
With saline as the test sample was added to the reagent, the reagent blank absorbance change rate (deltaA/min) should be less than 0.005.
3.4 Sensitivity Analysis
Test 120U/L alkaline phosphatase, the rate of change of the absorbance of the company in line with the given range.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 3100SI units and recommendations for the use of their multiples and of certain other units
- GB/T 21415In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- YY/T 0316Medical devices-Application of risk management to medical devices
- 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
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Related Standards
GB 3100-1993 — SI units and recommendations for the use of their multiples and of certain other units
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
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
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