[Precautions of physical performance requirements and test methods during product standard drafting process of medical devices].
The major idea of this article is to discuss standardization and normalization for the product standard of medical devices. Analyze the problem related to the physical performance requirements and test methods during product standard drafting process and make corresponding suggestions.
Song
Jin-Zi
JZ
SFDA Ji'nan Quality Supervision and Inspection Center for Medical Devices Ji'nan, Shandong. gold42@sina.com
Wan
Min
M
Xu
Hui
H
Yao
Xiu-Jun
XJ
Zhang
Bo
B
Wang
Jin-Hong
JH
D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D008422:Materials Testing / Q000379:methods; D014894:Weights and Measures