YY/T 1593-2018 English PDF

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YY/T 1593-2018: Growth hormone testing kit
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1593-2018	159	Add to Cart	3 days	Growth hormone testing kit	Valid

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Basic data

Standard ID: YY/T 1593-2018 (YY/T1593-2018)
Description (Translated English): Growth hormone testing kit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 8,824
Date of Issue: 2018-02-24
Date of Implementation: 2019-03-01
Quoted Standard: GB/T 191; GB/T 29791.2
Regulation (derived from): China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the scope of application of growth hormone assay kits, normative references, classifications, requirements, test methods, labels and instructions for use, packaging, transportation and storage. This standard applies to a kit for quantitative determination of growth hormone based on the principle of double antibody sandwich method. This standard does not apply to semi-quantitative determination of growth hormone reagents (eg, test strips, etc.) labelled with colloidal gold or other methods; various growth hormone radioimmunoassays or immunoradiometric reagents labeled with (125)I and other radioactive isotopes. box.

YY/T 1593-2018: Growth hormone testing 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.
Growth hormone testing kit ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Growth hormone assay kit Published by.2018-02-24 2019-03-01 Implementation The State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 Normative references 1 3 Category 1 4 Request 1 5 Test method 2 6 Labels and Operating Instructions 4 7 Packaging, Transport and Storage4 Reference 5

Foreword

This standard was 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 issuing agency of this document does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Laboratory Laboratory and the In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted by. China National Institute for Food and Drug Control, Henan Medical Device Inspection Institute, Guangzhou City Darui Biotechnology Co., Ltd. Limited company, Siemens Medical Diagnostics (Shanghai) Co., Ltd., Zhengzhou Antu Biological Engineering Co., Ltd. The main drafters of this standard. Yu Ting, Huang Jie, Qu Shoufang, Gao Shangxian, Zhang Juanli, Wu Yingsong, Wang Shaoying, Ma Xiaohui. Growth hormone assay kit

1 Scope

This standard specifies the scope of application of growth hormone assay kits, normative references, classifications, requirements, test methods, labels, and Instructions, packaging, transportation and storage. This standard applies to a kit for quantitative determination of growth hormone based on the principle of double antibody sandwich method. This standard does not apply to semi-quantitative determination of growth hormone agents using colloidal gold or other methods (eg test strips, etc.); use 125I. Radioisotope-labeled various types of growth hormone radioimmunoassay or immunoradioactive kits.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 packaging, storage and transportation logo GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labels) Part 2. In vitro diagnostic reagents for professional use Category 3 Different labeling methods can be divided into enzyme labels, (electro) chemiluminescent labels, (time-resolved) fluorescent labels, etc.; The same can be divided into micro-plate type, tube type, magnetic particles, microspheres and plastic beads, etc.; according to the different operating procedures can be divided into manual methods and instruments Automatic operation method.

4 Requirements

4.1 Appearance Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. The general composition and properties of the kit should be Requirements for packaging, labels, etc. 4.2 Limits Should not exceed 0.5ng/mL. 4.3 Linearity In the manufacturer's given linear range (the lower limit should not be higher than 1ng/mL, the upper limit should not be lower than 30ng/mL), the correlation coefficient (r) should be Not less than 0.9900. 4.4 Accuracy Accuracy should meet one of the following requirements. a) The calibrator in the kit is analyzed and determined at the same time with the corresponding concentration of growth hormone (or international) standards, using double logarithms or Fitting of other appropriate mathematical models requires that the two dose-response curves not deviate significantly from the parallel (t-test); ......

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