YY/T 1196-2013 English PDF

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YY/T 1196-2013: Chloride assay kit(Enzymic method)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1196-2013	209	Add to Cart	3 days	Chloride assay kit(Enzymic method)	Valid

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Basic data

Standard ID: 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: 9,938
Quoted Standard: YY/T 0466.1
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
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)

---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.
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. ......

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