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YY/T 1423-2016 English PDF

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YY/T 1423-2016: Testing kit for helicobacter pylori antibody(colloidal gold)
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YY/T 1423-2016English139 Add to Cart 3 days [Need to translate] Testing kit for helicobacter pylori antibody(colloidal gold) Valid YY/T 1423-2016

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Basic data

Standard ID YY/T 1423-2016 (YY/T1423-2016)
Description (Translated English) Testing kit for helicobacter pylori antibody(colloidal gold)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 7,775
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 191; 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, instruction manual, packaging, transportation and storage of the Helicobacter pylori antibody test kit (colloidal gold method). This standard is applicable to the quality control of the kit for the detection of Helicobacter pylori antibodies in human serum or plasma by colloidal gold method (hereinafter referred to as: Helicobacter pylori antibody detection kit).

YY/T 1423-2016: Testing kit for helicobacter pylori antibody(colloidal gold)

---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.
Testing kit for helicobacter pylori antibody (colloidal gold) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Helicobacter pylori antibody test kit (colloidal gold method) Testingkitforhelicobacterpyloriantibody (coloidalgold) 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. This standard by the China Food and Drug Research Institute and Beijing Kangmei Tianhong Biotechnology Co., Ltd. is responsible for drafting. The main drafters of this standard. Liang Haoyu, Wang Bin, Zhang Feng. Helicobacter pylori antibody test kit (colloidal gold method)

1 Scope

This standard specifies the requirements, test methods, labeling, labeling, instructions for use of the Helicobacter pylori antibody test kit (colloidal gold method) Packaging, transportation and storage. This standard applies to the colloidal gold method for the principle of qualitative detection of human serum or plasma Helicobacter pylori antibody kit (hereinafter. Helicobacter pylori antibody detection kit) quality control.

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. GB/T 191 Packaging and storage icon (ISO 780) YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (ISO 15223-1)

3 request

3.1 physical properties 3.1.1 Appearance. The kit should be complete label, complete composition; test strip closed preservation, no damage, no pollution. 3.1.2 Width. The width of the film should not be less than 2.5mm. 3.1.3 migration speed. liquid migration speed should not be less than 10mm/min. 3.2 positive reference product compliance rate With the national positive reference material or standardized positive reference for testing, the results should be positive. 3.3 Negative reference product compliance rate With a national negative reference material or a standardized negative reference material for testing, the results should be negative. 3.4 Minimum detection limit With the national minimum detection limit of national reference material or standardized minimum detection limit reference products for testing, the results should be consistent with the minimum detection limit Test the corresponding requirements. 3.5 Repeatability With the national repeat reference or standard repeatable reference products for testing, the results should be positive and uniform color uniformity. 3.6 stability You can use the following methods to verify. a) Duration stability. The kit is stored under the specified conditions until the end of the period, the physical properties of the test, positive reference product compliance rate, negative

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