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YY/T 1243-2014: Creatine kinase test reagent(kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1243-2014 | English | 279 |
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Creatine kinase test reagent(kit)
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YY/T 1243-2014
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Basic data | Standard ID | YY/T 1243-2014 (YY/T1243-2014) | | Description (Translated English) | Creatine kinase test reagent(kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 12,182 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB 3100; GB/T 21415-2008; YY/T 0316; YY/T 0466.1; YY/T 0638-2008 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of continuous monitoring method for serum or plasma creatine kinase activity quantitative detection of creatine kinase assay reagent (kit), including manual reagents and on the semi-automatic biochemical analyzer used. Thi | YY/T 1243-2014: Creatine kinase test reagent(kit)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Creatine kinase test reagent (kit)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Creatine kinase assay reagent (kit)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, BIOSINO Biotechnology Co., Ltd., Shanghai Fuxing Changzheng Medicine
Optical Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd. Beijing nine strong biotechnology.
The main drafters of this standard. Wang Jun, Wang Yunfeng, Wu Jie, Tian Wei, Zhou Ming, Du Haiou.
Creatine kinase assay reagent (kit)
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 continuous-monitoring
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 ℃, 340nm wavelength, under 1cm light path conditions, absorbance of the reagent blank should be less than 0.50.
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