Shuang Li, Bao-ai Chen, Zi-ming Peng
School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai.
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation 2009 NovThe IVD (In Vitro Diagnostic)Medical Devices are various and develop rapidly. This paper introduces briefly the principles of classification and conformity assessment for IVD medical that proposed by GHTF (Global Harmonization Task Force).
Shuang Li, Bao-ai Chen, Zi-ming Peng. The proposed principles by GHTF of the classification and assessment for in vitro diagnostic (IVD) medical devices]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation. 2009 Nov;33(6):438-40
PMID: 20352917
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