A discussion on the biological evaluation method for nanosilver antibiotic devices for gynecological external use.
- Author:
Gang-lin WANG
1
;
Hai-yan CHEN
Author Information
1. Chongqing Quality Testing & Inspection Center for Medical Devices, Chongqing.
- Publication Type:Journal Article
- MeSH:
Animals;
Anti-Bacterial Agents;
toxicity;
BALB 3T3 Cells;
Equipment and Supplies;
adverse effects;
Female;
Male;
Mice;
Nanostructures;
Rabbits;
Silver;
toxicity;
Toxicity Tests;
methods
- From:Chinese Journal of Medical Instrumentation
2006;30(6):451-443
- CountryChina
- Language:Chinese
-
Abstract:
Nanosilver antibiotic devices for gynecological external use are the third-class products of medical devices, whose biological safety and efficiency should be strictly controlled. But there is not yet the national standard or industry standard for the products to control the production process, so their testing method of biological evaluation mainly refers to GB/T16886 "The Guide to Implementation of Biological Evaluation of Medical Devices". To control the biological safety effectively, it's necessary to work out the testing items and methods of the biological evaluation for such products.
