YY/T 1243-2014Creatine kinase test reagent(kit) (English PDF)
肌酸激酶测定试剂（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 1243-2014 is the English-translated version of 肌酸激酶测定试剂（盒）.
YY/T 1243-2014 is the Chinese pharmaceutical industry standard for the creatine kinase assay reagent kit that measures the enzyme by continuous monitoring.
It gives the terms and definitions, the requirements, the test methods, the labels, the instruction leaflet and the rules for packaging, transport and storage, the requirements covering appearance, the blank absorbance, analytical sensitivity, linearity, precision, accuracy and stability.
It applies to kits for the quantitative determination of creatine kinase 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 1243-2014
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 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the creatine kinase assay reagent (kit) terms and definitions, requirements, test methods, labels, brochures, packaging, transportation And storage requirements.
This standard applies to the use of continuous monitoring method for plasma or serum creatine kinase activity for quantitative detection of creatine kinase assay reagent (Box), including manual reagents and on the semi-automatic biochemical analyzer used.
This standard does not apply to dry-type creatine kinase 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/medical devices metering the amount of biological sample measurement calibration and control materials in vitro diagnostic assignment T 21415-2008 Traceability of
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 Enzymatic YY/T 0638-2008 vitro diagnostic medical devices samples of biological origin quantity measurement calibration and control materials in Concentration assignment metrological traceability
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Continuous monitoring method
Under optimum conditions the enzyme reaction, multi-point monitoring throughout the course of the enzymatic reaction product or a reaction in the substrate due to changes over time Case, the reaction rate constant period, in the initial reaction rate per unit time of enzyme activity concentration of the enzyme was calculated.
4 Requirements
4.1 Appearance
In line with the provisions of the company's normal appearance requirements.
4.2 PACKING
Loading amount of the liquid reagent to be less than indicated value.
4.3 Reagent blank
4.3.1 Reagent blank absorbance
At 37 °C, 340nm wavelength, under 1cm light path conditions, absorbance of the reagent blank should be less than 0.50.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
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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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