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YY/T 1515-2017

Chinese Standard: 'YY/T 1515-2017'
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BASIC DATA
Standard ID YY/T 1515-2017 (YY/T1515-2017)
Description (Translated English) HIV-1 RNA quantitative assay
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,191
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Drafting Organization China Institute of Food and Drug Control, Roche Diagnostics (Shanghai) Co., Ltd., Merial Diagnostics (Shanghai) Co., Ltd. Beijing Company
Administrative Organization National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136)
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1515-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
HIV-1 RNA Quantitative Assay
人类免疫缺陷病毒(I 型)核酸定量检测试剂(盒)
ISSUED ON. MAY 02, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods ... 6
5 Mark, Label and Use Instructions ... 7
6 Package, Transportation and Storage ... 7
Bibliography ... 8
HIV-1 RNA Quantitative Assay
1 Scope
This Standard specifies the requirements, test methods, mark, label and use
instructions, package, transportation, storage, etc. of the HIV-1 RNA quantitative assay.
This Standard is applicable to the HIV-1 RNA reagent based on the nucleic acid
amplification methods (including real-time fluorescent PCR method, NASBA method
based on the nucleotide-amplification, and branched DNA, namely, bDNA method),
and used for quantitatively testing the human serum and/or plasma; it is abbreviated
as HIV-1 RNA quantitative assay.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191-2008 Packaging – Pictorial Marking for Handling of Goods
GB/T 29791.2-2013 In Vitro Diagnostic Medical Devices - Information Supplied by
the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Requirements
3.1 Appearance
The appearance shall meet the following requirements.
a) The components of the kit shall be complete, intact, and free of liquid-leakage;
b) Chinese packaging labels shall be clear and without wearing.
3.2 HIV-1 RNA positive reference compliance rate
Test with a national HIV-1 RNA positive reference or a standardized HIV-1 RNA positive
reference; the results shall be consistent with the corresponding reference product
4 Test Methods
4.1 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 3.1.
4.2 HIV-1 RNA positive reference compliance rate
Test with a national HIV-1 RNA positive reference or a standardized HIV-1 RNA positive
reference; operate as per the product instruction; the results shall meet the
requirements of 3.2.
4.3 HIV-1 RNA negative reference compliance rate
Test with a national HIV-1 RNA negative reference or a standardized HIV-1 RNA
negative reference; operate as per the product instruction; the results shall meet the
requirements of 3.3.
4.4 HIV-1 RNA quantitative reference
Test with a national HIV-1 RNA quantitative reference or a standardized HIV-1 RNA
quantitative reference; operate as per the product instruction; the results shall meet
the requirements of 3.4.
4.5 HIV-1 RNA sensitivity reference
Test with a national HIV-1 RNA sensitivity reference or a standardized HIV-1 RNA
sensitivity reference; operate as per the product instruction; the results shall meet the
requirements of 3.5.
4.6 HIV-1 RNA linear reference
Test with a national HIV-1 RNA linear reference or a standardized HIV-1 RNA linear
reference; operate as per the product instruction; the results shall ......
Related standard:   YY/T 1513-2017  YY/T 1514-2017
Related PDF sample:   YY/T 1513-2017
   
 
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