YY/T 0659-2008 (YYT 0659-2008)

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YY/T 0659-2008
Automated coagulation analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Automatic coagulation analyzer
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard is mainly drafted by. Sysmex Medical Electronics (Shanghai) Co., Ltd., Beijing Medical Device Testing, Sida high diagnostic technology
Limited surgery, Beckman Coulter, Inc., PLA General Hospital.
The main drafters of this standard. Li Lin, PENG Li-ming, continued Yong, Zhang, Tang Xiaomei, He Xueying Li Jian.
Automatic coagulation analyzer
1 Scope
This standard specifies the automatic coagulation analyzer terms and definitions, classification and composition requirements, test methods, marking, labeling, instructions for use
Books, packaging, transportation and storage.
This standard applies to blood coagulation and anticoagulation, fibrinolysis and antifibrinolytic functional analysis automatic coagulation analyzer. This standard specifies
Instrument for detecting prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin
Time (TT) detection of the technical requirements for blood clotting factor, the technical requirements of D-dimer (D-dimer) and other testing is not specified in this standard.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 191-2000 Packaging - Pictorial signs
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements (GB 4793.1-
2007, IEC 61010-1.2001, IDT)
GB/T 14710 Medical electrical equipment environmental requirements and test methods
YY 0466-2003 medical equipment used with medical device labels, signs and symbols provide information (ISO 15223.2000, IDT)
YY 0648-2008 measurement, control and laboratory use - Part 2-101 safe electrical equipment. in vitro diagnostic medical devices designed
With requirements (IEC 61010-2-101.2002, IDT)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Liquid sample can be used for the determination of the detection system, including calibrators, controls, and other fresh plasma or whole blood.
3.2
Including the system liquid sample and reagents consisting of all added, the measurement results obtained parameters.
3.3
Applied to the instrument or system characteristics. All analysis process including sample and reagent additions, physical, chemical and biological analysis, the results count
Calculation and result display are mechanized.
3.4
Under specified conditions, the number of tests performed per unit of time, usually expressed as "the number of tests/h". Test speed and test-related projects.
3.5
The system will detect a sample of the reaction to the reaction to bring another sample, thereby affecting the performance of the error amounts to another sample.