The proposed principles by GHTF of the classification and assessment for in vitro diagnostic (IVD) medical devices.
- Author:
Shuang LI
1
;
Bao-ai CHEN
;
Zi-ming PENG
Author Information
1. School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai.
- Publication Type:Journal Article
- MeSH:
Diagnostic Techniques and Procedures;
instrumentation;
Equipment and Supplies, Hospital;
classification
- From:
Chinese Journal of Medical Instrumentation
2009;33(6):438-440
- CountryChina
- Language:Chinese
-
Abstract:
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).
