YY/T 1233-2014 English PDF (YYT1233-2014)

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YY/T 1233-2014: Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
YY/T 1233-2014
Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
-I Quantitative cardiac troponin assay reagent (kit)
(Chemiluminescent immunoassay)
Cardiactroponin-I (cTnI) quantitativedetectionreagent (kit)
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. Release mechanism of the present document does not assume responsibility for the identification of 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.
Drafting of this standard. Beijing Medical Device Testing, Zhengzhou, the Biological Engineering Co., Ltd. Green Branch, Beckman Coulter Suppliers
Trade (China) Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Johnson and Johnson (Shanghai) Medical Equipment has
Limited.
The main drafters of this standard. Wangrui Xia, Li Xiaoxia, Zhang Jinwen, Duhai Ou, Liu Rong, Wang Xuefeng, Qi Xin.
-I Quantitative cardiac troponin assay reagent (kit)
(Chemiluminescent immunoassay)
1 Scope
This standard specifies the quantitative determination of cardiac troponin -I reagent (box) (chemiluminescent immunoassay) terms and definitions, requirements, test
Methods, marking, labeling, instructions, packaging, transport and storage.
This standard applies to the principles of the quantitative determination of human cardiac troponin -I (cTnI) quantitative assay reagent (kit) chemiluminescence immunoassay for the
[Hereinafter referred to as "cTnI reagent (kit)"], including microplates, tubes, as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay measuring magnetic particles, etc.
Given reagent (box).
This standard does not apply in the kit calibrators and controls requirements.
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 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Blank limit limitofblank; LOB
In claiming that the probability of observable highest measurements blank sample.
[NCCLS, EP17]
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) reagent (box) of each component should be complete, complete, no liquid leakage;
b) Chinese packaging labels should be clear, no wear.
4.2 Traceability
Manufacturers should provide a source with cTnI calibrators according to GB/T 21415 and the relevant provisions of the assignment process traceability and corresponding to
Demand and uncertainty and so on.
4.3 Accuracy
Accuracy should meet one of the requirements are as follows.