[The proposed principles by GHTF of the classification and assessment for in vitro diagnostic (IVD) medical devices].
The 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).
Li
Shuang
S
School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai.
Chen
Bao-ai
BA
Peng
Zi-ming
ZM
D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation*; D004865:Equipment and Supplies, Hospital / Q000145:classification*