Precautions of physical performance requirements and test methods during product standard drafting process of medical devices.
- Author:
Jin-Zi SONG
1
;
Min WAN
;
Hui XU
;
Xiu-Jun YAO
;
Bo ZHANG
;
Jin-Hong WANG
Author Information
1. SFDA Ji'nan Quality Supervision and Inspection Center for Medical Devices Ji'nan, Shandong. gold42@sina.com
- Publication Type:Journal Article
- MeSH:
Device Approval;
Equipment and Supplies;
standards;
Materials Testing;
methods;
Weights and Measures
- From:
Chinese Journal of Medical Instrumentation
2009;33(5):374-378
- CountryChina
- Language:Chinese
-
Abstract:
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.
