YY/T 1228-2014 English PDF

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YY/T 1228-2014: Albumin test reagent kit
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1228-2014	259	Add to Cart	3 days	Albumin test reagent kit	Valid

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Basic data

Standard ID: YY/T 1228-2014 (YY/T1228-2014)
Description (Translated English): Albumin 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: 11,191
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB 3100; YY/T 0316; YY/T 0466.1
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 bromocresol green method, bromocresol purple method for serum, plasma and other body fluids albumin quantitative detection of albumin assay reagent (box). This Standard specifies the albumin assay reagent (box) requirem

YY/T 1228-2014: Albumin 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.
Albumin test reagent kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Albumin 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, Shanghai Rongsheng Sheng-Pharmaceutical Co., Ltd., Beijing Leadman Biochemistry Co. Shares Company, Beijing Branch Medical Technology Co., Ltd. Kang Datai. The main drafters of this standard. Yangzong Bing, Zhang Zhengjiang, Duhai Ou, Wang Lanzhen, Wang Li. Albumin assay reagent (kit)

1 Scope

This standard specifies the albumin assay reagent (kit) requirements, test methods, labels, brochures, packaging, transportation and storage. This standard applies to measuring albumin using bromocresol green method, bromocresol purple method for serum, plasma and other body fluids quantitative detection of albumin Given reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used. This standard does not apply to dry chemical assay reagents.

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 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

3 Requirements

3.1 Appearance In line with the provisions of the company's normal appearance requirements. 3.2 PACKING Not less than the indicated value. 3.3 reagent blank absorbance Producers meet the requirements specified. 3.4 Sensitivity Analysis Producers meet the requirements specified. 3.5 Linear Interval Serum samples were tested in a linear reagent [10.0,60.0] g/L range. a) The linear correlation coefficient ︱r︱ not less than 0.990; b) within [10.0,20.0] g/L range, linearity deviation should be ± 4.0g/L within the range; [20.1,60.0] in the g/L range, linearity deviation should not exceed ± 10.0%. 3.6 Precision 3.6.1 Repeatability Repeat the test concentrations (40 ± 5) g/L of serum control, the results of the repeatability (coefficient of variation, CV) should not exceed 2.0%. ......

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