YY/T 1235-2014 (YY/T1235-2014, YYT 1235-2014, YYT1235-2014) & related versions
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Rubella virus IgG / IgM antibody detection kit
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YY/T 1235-2014
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YYT 1235-2014
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YY/T 1235-2014: PDF in English (YYT 1235-2014)
YY/T 1235-2014
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Rubella IgG / IgM antibody detection kit
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements ... 4
4 Test methods ... 6
5 Marking, labeling, and instructions ... 7
6 Packaging, transportation, and storage ... 9
References ... 10
Foreword
This Standard was drafted according to the rules given by GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this Document does not undertake the responsibility for the identification
of these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the Standardization Technical
Committee of National Medical Clinical Test Laboratory and in Vitro Diagnostic
System (SAC/TC 136).
Drafting organizations of this Standard. National Institutes for Food and Drug Control.
Main drafters of this Standard. Huang Jie, Qu Shoufang, and Gao Shangxian.
Rubella IgG / IgM antibody detection kit
1 Scope
This Standard specifies the requirements, test methods, marking, labeling,
instructions manual, packaging, transportation, and storage of rubella IgG / IgM
antibody detection kit (hereinafter referred to as "reagents (kit)").
This Standard applies to the qualitative detection of rubella IgG / IgM antibody in
human serum/plasma detection kit (enzyme-linked immunosorbent assay method),
rubella IgG / IgM antibody detection kit (chemiluminescence method), rubella IgG /
IgM antibody detection kit (immunofluorescence method), rubella IgG / IgM antibody
detection kit (Immunoblotting method), etc.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Standard.
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labeling and information to be supplied - Part 1. General requirements
3 Requirements
3.1 Technical requirements for rubella IgG antibody detection kit
3.1.1 Appearance
Appearance shall meet the following conditions.
a) Reagents (kit) shall meet the appearance requirements specified by the
manufacturer;
b) The components of reagents (kit) shall be complete. The appearance of
packaging shall be clean, no leaks, no damage. Signs and labels shall be legible.
3.1.2 Accuracy (positive coincidence rate)
USE rubella IgG antibody detection reagents to test national positive reference
materials or standardized positive reference materials. The results shall meet the
requirements.
p) Precautions;
q) References;
r) Name, address, contact details of manufacturer or after-sales service
organization;
s) Domestic medical device manufacturer shall indicate manufacturer license
number;
t) Medical device registration certificate number;
u) Product standard number;
v) Instructions approval and modification date.
6 Packaging, transportation, and storage
6.1 Packaging
Pictorial markings for packaging, transportation, and storage shall comply with the
specifications of YY/T 0466.1. Reagents (kit) shall be packaged according to the
requirements of manufacturer.
6.2 Transportation
Reagents (kit) shall be transported according to the requirements of manufacturer.
6.3 Storage
Reagent (kit) shall be stored under the conditions specified by manufacturer.
References
[1] GB/T 191-2008 Packaging - Pictorial marking for handling of goods
[2] GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of
quantities in biological samples - Metrological traceability of values assigned to
calibrators and control materials
[3] GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the
manufacturer (labeling) - Part 1. Terms, definitions and general requirements
[4] YY/T 0316 Medical devices - Application of risk management to medical devices
[5] EN 375-2001 Information supplied by the manufacturer with in vitro diagnostic
reagents for professional use
[6] EN 980-2003 Graphical symbols for use in the labeling of medical devices
[7] EP 17-A Protocols for Determination of Limits of Detection and Limits of
Quantitation, Approved Guideline, CLSI, 2004
......
| Standard ID | YY/T 1235-2014 (YY/T1235-2014) | | Description (Translated English) | Rubella virus IgG / IgM antibody detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,848 | | Date of Issue | 2014/6/17 | | Date of Implementation | 2015/7/1 | | Quoted Standard | YY/T 0466.1 | | Drafting Organization | Chinese Institute of Food and Drug test | | Administrative Organization | National medical clinical laboratory testing and in vitro diagnostic systems Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the qualitative detection of human serum/plasma rubella virus IgG/IgM antibody detection reagent (box) (enzyme-linked immunosorbent assay), rubella virus IgG/IgM antibody detection reagent (box) (chemiluminescence), rubella virus |
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