YY/T 0654-2008 (YYT 0654-2008)

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YY/T 0654-2008
Automatic Chemistry Analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Automatic biochemical analyzer
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard "biochemical analyzer" on the basis of YY 0014-1990 formulated for use liquid reagent automatic biochemical points
Analyzer.
Appendix A of this standard is a normative appendix, Appendix B is an informative annex.
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 was drafted. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Hitachi High-Technologies Corporation (China Business Group), Beijing
On Pine Technology Co., Ltd., Beijing Medical Device Testing, Beckman Coulter.
The main drafters of this standard. Wang Wei, Xie Chuan Fen, Yang Fan, Fu Yuguang, Wang Jun, Bi Xiao.
Automatic biochemical analyzer
1 Scope
This standard specifies automatic biochemical analyzer (hereinafter referred to as the analyzer) terms and definitions, classification, requirements, test methods, inspection regulations
Then, signs and instructions, packaging, transportation and storage.
This standard applies to the use of liquid reagents for a variety of samples for quantitative analysis analyzer.
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 Packaging - Pictorial signs
GB 4793.1 measurement, control and laboratory use safety requirements for electrical equipment - Part 1. General requirements
GB/T 2829-2002 period inspection Sampling procedures and sample forms (for checking the stability of the production process)
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)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
The ratio of the intensity of the transmitted light is incident light intensity transmittance; transmittance reciprocal common logarithm called absorbance.
Note. This standard, all absorbance values refer to the value of the optical path 10mm Time.
3.2
All analysis process (including filling samples and reagents react with each other, chemical and biological analysis, the results of calculations and the results read out) have implemented
Automated biochemical analyzer.
3.3
By the measurement system will carry a test sample reaction to detect the analyte another sample of the reaction of discrete quantities, thereby affecting the error
The performance of another quantity of the test sample.
3.4
Measurement wavelength other than the deviation from the normal optical path of light reaching the detector.
3.5
Detection light reaching the previous cuvette has been a light into spectral components within the bandwidth, also known as forward optical path.
3.6
Detecting light through the cuvette after the device is split into a light within the bandwidth, also known as reverse optical path.