纳米银妇女外用抗菌器生物学评价方法的初探

钠米银妇女外用抗菌器划归为医疗器械三类管理,属于对其安全性、有效性必须严格控制的医疗器械。该产品目前没有国家标准和行业标准．其生物学评价主要是参考GB／T16886《医疗器械生物学评价实施指南》,为了便于有效地控制该产品的安全性．有必要建立该产品的生物学评价项目和方法。

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.