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YY/T 1196-2013

Chinese Standard: 'YY/T 1196-2013'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1196-2013English179 Add to Cart Days<=3 Chloride assay kit(Enzymic method) Valid YY/T 1196-2013
YY/T 1196-2013Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY/T 1196-2013; YY/T1196-2013
Description (Translated English): Chloride assay kit(Enzymic method)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 9,916
Quoted Standard: YY/T 0466.1
Drafting Organization: Chinese Academy of Food and Drug Testing
Administrative Organization: National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: chlorine assay kit (enzymatic) technical requirements, test methods, labeling, instructions for use, packaging, transportation and storage. This standard applies to: chlorine (CL) assay kit (enzymatic) Quality Control.


YY/T 1196-2013
Chloride assay kit (Enzymic method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Chlorine assay kit (enzymatic)
Issued on: 2013-10-21
2014-10-01 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 standard may involve patents. The standard release
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 drafting unit: China Academy of Food and Drug test.
The main drafters of this standard: Sun Nan, Wang Yumei, Liu Yan, the first noble, Zhangchun Tao.
Chlorine assay kit (enzymatic)
1 Scope
This standard specifies the chlorine assay kit (enzymatic) requirements, test methods, labeling and instructions for use, packaging, transportation and storage.
This standard applies to chlorine assay kit (enzymatic) quality control.
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information: General requirements
3 Requirements
3.1 Appearance
Compatible with the manufacturer's normal appearance requirements.
3.2 PACKING
Loading amount of the liquid reagent to be less than the labeled amount.
3.3 reagent blank
3.3.1 Reagent blank absorbance
Reagent blank absorbance ≤1.0 (wavelength 405nm, light trails 1.0cm).
3.3.2 Reagent blank absorbance change rate
Reagent blank absorbance change rate ≤0.300/min (wavelength 405nm, light trails 1.0cm).
3.4 linear range
In 140mmol/L range 60mmol/L ~, the linear correlation coefficient (r) shall not be less than 0.9900.
3.5 Accuracy
You can use the following methods:
a) the relative deviation: provide reference materials or reference methods serum reference measurement values, marked deviation of the measured value and the value in the range of ± 15.0%
Enclosed within;
b) recovering the experiment: The determination of calibrator, kits recovery should be within the range of 90% to 110%;
c) comparative experiments: no calibrator to comparison method for determining, r≥0.9900.
3.6 Sensitivity Analysis
When reagent (kit) test analyte absorbance difference (ΔA) or change in absorbance should be consistent with manufacturer's given range.
Related standard:   YY/T 1197-2013  YY/T 1198-2013
   
 
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