[A discussion on the biological evaluation method for nanosilver antibiotic devices for gynecological external use].
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.
Wang
Gang-lin
GL
Chongqing Quality Testing & Inspection Center for Medical Devices, Chongqing.
Chen
Hai-yan
HY
D000818:Animals; D000900:Anti-Bacterial Agents / Q000633:toxicity*; D041702:BALB 3T3 Cells; D004864:Equipment and Supplies / Q000009:adverse effects*; D005260:Female; D008297:Male; D051379:Mice; D049329:Nanostructures; D011817:Rabbits; D012834:Silver / Q000633:toxicity*; D018675:Toxicity Tests / Q000379:methods
D000900:Anti-Bacterial Agents; D012834:Silver