YY/T 1444-2016 English PDF

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YY/T 1444-2016: Total protein test reagent
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1444-2016	159	Add to Cart	3 days	Total protein test reagent	Valid

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Basic data

Standard ID: YY/T 1444-2016 (YY/T1444-2016)
Description (Translated English): Total protein test reagent
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,890
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, labels, instructions for use, packaging, transport and storage of the total protein assay kit (biuret method). This standard applies to the use of biuret method for human serum (plasma) in the quantitative detection of the total protein kit, based on the principle of spectrophotometry, including manual reagents and semi-automatic, automatic biochemical analyzer used in the reagent. This standard does not apply to the total protein assay kit for dry chemical methods.

YY/T 1444-2016: Total protein 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.
Total protein test reagent ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Total Protein 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, the Health and North Biological Technology Co., Ltd., Xisen US Kang biotechnology (no Tin) Co., Ltd., Hitachi High-tech (Shanghai) International Trade Co., Ltd. Beijing Branch, Shanghai Kehua Biological Engineering Co., Ltd. The main drafters of this standard. Yang Zongbing, Jiang Lin, Hu Fangyu, Cheng Qing, Xiao Lu Sheng. Total Protein Assay Kit

1 Scope

This standard specifies the requirements, test methods, labels, instructions, packaging, shipping and storage of the total protein assay kit (biuret method) And so on. This standard is applicable to the use of biuret method for human serum (plasma) in the total protein quantitative detection kit, based on spectrophotometry Including hand reagents and reagents used in semi-automatic, fully automated biochemical analyzers. This standard does not apply to the total protein assay kit for dry chemical methods.

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 The net content of the liquid reagent shall be not less than the indicated value. 3.3 Reagent Blank Absorbance Reagent blank absorbance should not be greater than 0.200. 3.4 Analysis of sensitivity 70g/L sample absorbance difference (ΔA) should be not less than 0.150. 3.5 Linearity The linear range of the kit should cover [30.0,100.0] g/L. a) the linear correlation coefficient r should be not less than 0.995; b) The linear deviation should not exceed ± 6.0%. 3.6 precision 3.6.1 Repeatability Repeat the test (70.0 ± 10.0) g/L of the sample, the results of the coefficient of variation (CV) should not be greater than 2%. ......

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