YY/T 1421-2016 English PDF

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YY/T 1421-2016: Apolipoprotein B test reagent
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1421-2016	159	Add to Cart	3 days	Apolipoprotein B test reagent	Valid

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Basic data

Standard ID: YY/T 1421-2016 (YY/T1421-2016)
Description (Translated English): Apolipoprotein B test reagent
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,834
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: YY/T 0466.1
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements, test methods, labeling, labeling and instructions for use of the apolipoprotein B assay kit, packaging, transport and storage requirements. This standard applies to the immunoturbidimetric method (transmission method) on human serum or plasma apolipoprotein B quantitative detection of the kit, including manual and semi-automatic, automatic biochemical analyzer on the use of reagents.

YY/T 1421-2016: Apolipoprotein B test reagent

---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.
Apolipoprotein B test reagent ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Apolipoprotein B assay kit 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Device Testing Institute, Shanghai Rongsheng Biological Pharmaceutical Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Jiangxi Tekang Technology Co., Ltd., the British Branch of the new (Xiamen) Technology Co., The main drafters of this standard. Bi Chunlei, Zhang Zhengqiang, Du Haiou, Tang Wei, Yan Xiao, Du Jiao. Apolipoprotein B assay kit

1 Scope

This standard specifies the requirements for apolipoprotein B assay kits, test methods, labeling, labeling and instructions, packaging, shipping and storage. And other requirements. This standard applies to immunoturbidimetry (transmission method) for human serum or plasma apolipoprotein B quantitative detection of the kit, including Manual and semi-automatic, automatic biochemical analyzer used on the reagent.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 request

3.1 appearance Should specify the normal appearance requirements. 3.2 Capacity Should not be less than the marked value. 3.3 Reagent Blank Absorbance Should specify the reagent blank absorbance requirements. 3.4 Analysis of sensitivity Test the concentration of 1.00g/L of the sample, absorbance difference (ΔA) should be less than 0.15. Note. The test wavelength is 340nm, other test wavelengths or through the sample pre-dilution test can be adjusted accordingly. 3.5 Linearity The linear range of the kit should cover [0.40,2.00] g/L. a) The linear correlation coefficient (r) should be not less than 0.990; b) [0.40,2.00] g/L interval, the linear deviation should not exceed ± 10%. 3.6 precision 3.6.1 Repeatability Repeated test (1.00 ± 0.50) g/L of human serum or control substance, the results of the coefficient of variation (CV) should not be greater than 3%. ......

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