YY/T 1514-2017 (YY/T1514-2017, YYT 1514-2017, YYT1514-2017) & related versions
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Detection kit for antibodies to HIV-1 and HIV-2(western blotting)
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YY/T 1514-2017
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YYT 1514-2017
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YY/T 1514-2017: PDF in English (YYT 1514-2017)
YY/T 1514-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Detection kit for antibodies to HIV-1 and HIV-2
(western blotting)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 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 method ... 5
5 Marking, labelling and instructions for use ... 6
6 Packaging, transportation and storage ... 6
Bibliography ... 7
Detection kit for antibodies to HIV-1 and HIV-2
(western blotting)
1 Scope
This Standard specifies the requirements, test method, marking, labelling, instructions
for use, packaging, transportation, storage, etc. of detection kit for antibodies to HIV-1
and HIV-2 (western blotting).
This Standard applies to reagents for qualitative detection of antibodies to HIV-1 and
HIV-2 using the western blotting method (including the recombinant immunoblotting
method), to fix the multicomponent antigens or recombinant expression
multicomponent antigens to the different locations of nitrocellulose membrane using
the SDS-PAGA method or the direct sample application method, i.e. detection kits for
antibodies to HIV-1 and HIV-2 (western blotting).
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to this document.
GB/T 191, Packaging – Pictorial marking for handling of goods
GB/T 29791.2, 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
Appearance shall comply with the following requirements.
a) all components of kits shall be complete and there is no leakage of liquid;
b) packaging labels in Chinese shall be clear without wear.
3.2 Compliance of positive references for antibodies
4.3 Compliance of negative references for antibodies
Use national negative references or standardized negative references for testing,
operate as specified in the instructions for use, and the results shall comply with the
requirements of 3.3.
4.4 Compliance of uncertain references for antibodies
Use national uncertain references or standardized uncertain references for testing,
operate as specified in the instructions for use, and the results shall comply with the
requirements of 3.4.
4.5 Stability
Use the following methods.
a) validity stability. obtain kits of a certain time within validity, operate as specified in
the instructions for use, and the results shall comply with the requirements of 3.5.2;
b) thermal stability. place kits aside for a certain time at certain temperature (normally
37°C), operate as specified in the instructions for use, and the results shall comply with
the requirements of 3.5.2.
5 Marking, labelling and instructions for use
As specified in GB/T 29791.2-2013.
6 Packaging, transportation and storage
6.1 Packaging
The pictorial marks for packaging, storage and transportation shall be as specified in
GB/T 191-2008. The packaging containers shall well sealed and complete without
leakage or damage.
6.2 Transportation
Kits shall be transported as required by the manufacturer. During the process of
transportation, protect them from exposure to damp, heavy loads, direct sunlight, rain
and snow and acid-base materials and damage of exterior and interior packaging.
6.3 Storage
Kits shall be stored under the conditions specified by the manufacturer.
......
| Standard ID | YY/T 1514-2017 (YY/T1514-2017) | | Description (Translated English) | Detection kit for antibodies to HIV-1 and HIV-2(western blotting) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 6,679 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | China Institute of Food and Drug Control, Beijing Wantai Bio-Pharmaceutical Co., Ltd. | | 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 |
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