YY/T 1193-2011 English PDF (YYT1193-2011)

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YY/T 1193-2011: Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
YY/T 1193-2011
Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Follicle stimulating hormone (FSH) quantitative assay kit
(Chemiluminescent immunoassay)
Foliclestimulatinghormone (FSH) quantitativeimmunoassaykit
Issued on. 2011-12-31
2013-06-01 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. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the State 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. Beijing Medical Device Testing, Beijing Tak source of Biomedical Engineering Co., Ltd., China Pharmaceutical and Biological Products Inspection
Given the in vitro diagnostic reagents and media, Beijing Icahn times Biotechnology Co., Ltd., Johnson and Johnson (Shanghai) Medical Equipment Co., Ltd.
The main drafters of this standard. Wangrui Xia, Tang Lei, Huang Ying, Wang Jianming, Nie Jing.
Follicle stimulating hormone (FSH) quantitative assay kit
(Chemiluminescent immunoassay)
1 Scope
This standard specifies the follicle stimulating hormone (FSH) quantitative assay reagent (kit) Classification (chemiluminescent immunoassay) products to
Requirements, test methods, marking, labeling, instructions, packaging, transportation and storage.
This standard applies to chemiluminescent immunoassay for the quantitative determination of the principles of human blood or other body fluid matrix components in the follicle
Hormone (FSH) quantitative assay reagent (box) (hereinafter referred to as "FSH reagent (kit)"). Including microplates, tubes, magnetic particles, beads and plastic beads
As the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay assay reagent (kit).
This standard does not apply to.
a) to be used for sales of individual follicle stimulating hormone calibrators and control materials follicle stimulating hormone;
b) by CLIA for the principle of biochips.
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
Category 3
FSH reagent (box) in accordance with the principle of chemiluminescence can be divided into enzymatic and non-enzymatic chemiluminescence immunoassay reagent (kit); solid basis
Phase carrier can be divided into microtiter plate, pipe, magnetic particles, beads and plastic beads as the carrier chemiluminescence immunoassay kit); root
It can be divided into different processes operating manual method and automated method of automatic operation.
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) reagent (kit) the components should be complete, packaging intact, no liquid leakage;
b) Chinese packaging labels should be clear, no wear.
4.2 Traceability
Manufacturers should provide sources with FSH reagent (box) calibrator according to GB/T 21415-2008 and the relevant provisions, the assignment process
And the measurement uncertainty and so on.
4.3 Accuracy
Accuracy should meet one of the requirements are as follows.