YY/T 1183-2010 English PDF (YY/T1183-2010)

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YY/T 1183-2010: Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
YY/T 1183-2010
Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Enzyme-linked immunosorbent assay reagent (kit)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Beijing Jinwei Kai Medical Biotechnology Co., Ltd., Shanghai Fuxing Changzheng Medical
Science Co., Beckman Coulter Trading (China) Limited.
The main drafters. Zhang Xinmei, He Xueying, Zhu Wang, Wu Jie, Zhang Jinwen.
Enzyme-linked immunosorbent assay reagent (kit)
1 Scope
This standard specifies the enzyme-linked immunosorbent assay reagent (kit) general technical requirements, including terminology and definitions, classification, requirements, test side
Method, labeling and instructions, packaging, transport and storage.
This standard applies to medical laboratory tests to ELISA method for the principle of quantitative/qualitative detection reagent (box) (hereinafter
Called "kit").
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 21415-2008 vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrology
Traceability
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
ELISA enzyme-linkedimmunoabsorbentassay, ELISA
Enzyme as a marker indicator for antigen-antibody reaction, based on the degree of coloration by the color of the original judgment result of solid phase adsorption test side
law. Coloration degree absorbance (A) value indicates the measured value and the level of A antigen or antibody test showed a correlation.
Note. the solid support comprises a microtiter plate, tubes, magnetic particles, beads, plastic beads and other carriers.
3.2
Enzyme-linked immunosorbent assay kit detectionkitforELISA
Intended for use with ELISA method for the principle to complete a specific set of components in vitro diagnostic test points may contain coated solid support,
Antibody/antigen, conjugate, buffers, coloring systems, dilution, calibrators, controls and so on.
3.3
Packaging immediatecontainer, primarycontainer
Prevent contamination of the contents of the external environment and other impacts of packaging.
Example. seal vials, ampoules or bottles, foil bags, sealed plastic bag.
[ISO /FDIS18113-1, the definition 3.24]
3.4
Packaging (sales packaging) outercontainer (salespackaging)
Packaging materials used for packaging reagent (box).
NOTE. rewrite the ISO /FDIS18113-1, definitions 3.49.
3.5
Identification label
Printed, written or graphic information on in vitro diagnostic product or its packaging.