YY/T 1482-2016 English PDF

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YY/T 1482-2016: Anti-herpes-simplex-virus IgG antibody detection reageant(kit)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1482-2016	199	Add to Cart	3 days	Anti-herpes-simplex-virus IgG antibody detection reageant(kit)	Valid

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Basic data

Standard ID: YY/T 1482-2016 (YY/T1482-2016)
Description (Translated English): Anti-herpes-simplex-virus IgG antibody detection reageant(kit)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 10,152
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration

YY/T 1482-2016: Anti-herpes-simplex-virus IgG antibody detection reageant(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.
Anti-herpes-simplex-virus IgG antibody detection reageant (kit) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Herpes simplex virus IgG antibody test reagent (box) 2016-07-29 released 2017-06-01 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 unit of this standard. China Food and Drug Administration Research Institute. The main drafters of this standard. Huang Jie, Qu Shoufang, Gao Shangxian Herpes simplex virus IgG antibody test reagent (box)

1 Scope

This standard specifies the technical requirements for herpes simplex virus IgG antibody detection reagent (box) [hereinafter referred to as "reagent"), Law, labeling, labeling and instructions, packaging, transportation and storage. This standard applies to the qualitative detection of human serum/plasma herpes simplex virus type 1 IgG antibody detection reagent (box), herpes simplex virus 2 type IgG antibody detection reagent (box), herpes simplex virus type 1 IgG antibody detection reagent (box), methodology for enzyme-linked immunoassay, chemical Luminescence method, immunofluorescence method, immunoblotting method and the like.

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 Herpes simplex virus type 1 IgG antibody detection reagent (box) 3.1.1 appearance Appearance should meet the following requirements. a) kit components should be complete, complete, liquid without leakage; b) Chinese packaging labels should be clear, no wear. 3.1.2 positive reference product compliance rate A positive reference substance (dish) or a standardized positive reference was used for the detection of a herpes simplex virus type 1 IgG antibody assay reagent, The results should meet the requirements. 3.1.3 Negative reference product compliance rate A test was conducted with a herpes simplex virus type 1 IgG antibody assay reagent for a national negative reference or a standardized negative reference. Should meet the requirements. 3.1.4 Minimum detection limit With the herpes simplex virus type 1 IgG antibody detection reagent on the country's lowest detection limit reference material or the lowest reference limit Line test, the results should meet the requirements. 3.1.5 Repeatability Depending on the product characteristics, one of the following methods a) or b) can be verified. ......

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