YY/T 1240-2014 English PDF (YY/T1240-2014)

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YY/T 1240-2014: D-Dimer reagent (kit)
YY/T 1240-2014
D-Dimer reagent (kit)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
D- dimer quantitative detection reagent (box)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
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 was proposed by the China Food and Drug Administration.
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. PLA General Hospital, Beijing Medical Device Testing, Beijing Saikexide Technology Development Co., Wofen Medical
Spa Equipment International Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Li Jian, Bi Chunlei, Ding Hui heavy afterglow.
D- dimer quantitative detection reagent (box)
1 Scope
This standard specifies the D- dimer quantitative detection reagent (box) terms and definitions, requirements, test methods, marking, labeling and instructions for use
Books, packaging, transportation and storage.
This standard applies to laboratory tests using immunological nephelometry D- dimer quantitative detection reagent (box) products (hereinafter referred to as DD reagent).
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 191 Packaging - Pictorial signs
GB 3100 International System of Units and Its Application
GB 3101 general principles relating to amounts, units and symbols
GB 3102 (all parts), Quantities and Units
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Immunoturbidimetry D- dimer testing immunoturbidimetricD-dimerassay
Soluble fibrin monoclonal antibody coated latex particles uniformly by the plasma having an antigenic determinant DD Laid degradation products
Heterosexual combination of the latex particles bonded to each other, the degree of aggregation and concentration of samples D- dimer proportional relationship. Under certain wavelengths pass
By measuring change in transmitted light or scattered light caused by aggregation of values obtained D- dimer.
3.2
QC plasma controlplasma
Laboratory testing system for monitoring the stability of citrate plasma products. The detection system comprising such reagents, instruments, reconstitution or dilution
Liquid and sample devices.
Note 1. The "normal quality control plasma" assignment within the scope of the reference range.
Note 2. In "exceptional quality control plasma," the assignment is not in the scope of the reference interval, may have low and high quality control abnormal plasma.
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) The kit should look clean and clear identification text symbols;
b) D- dimer latex reagent should be uniform emulsion (dry reagent should meet this requirement) after reconstitution;
c) D- dimer buffer was a clear solution, no precipitate or floc.