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YY/T 1235-2014 English PDF (YYT1235-2014)

YY/T 1235-2014 English PDF (YYT1235-2014)

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YY/T 1235-2014: Rubella virus IgG / IgM antibody detection kit

This Standard specifies the requirements, test methods, marking, labeling, instructions manual, packaging, transportation, and storage of rubella IgG / IgM antibody detection kit..
YY/T 1235-2014
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the PEOPLE 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

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