医疗器械生物学评价中的病理学探讨

Pathological Discussion in Biological Evaluation of Medical Devices

GB/T 16886.10-2017《医疗器械生物学评价第10部分:刺激与皮肤致敏试验》是我国现行的医疗器械刺激实验的国家标准,对医疗器械检验具有重要的指导作用。该研究主要从病理学原则、病变性质及其机制比较分析,并结合实际操作中的可行性,对该国标中的几个病理学记分系统等方面提出改进建议。

GB/T 16886.10-2017《Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization》is the current national standard for irritation tests of medical devices in China,which has an important guiding role for medical device inspection.This article mainly proposes improvement suggestions on several pathological scoring systems in the national standard based on comparative analysis of pathological principles,the features of lesions and their mechanisms,and in combination with the fe asibility of actual operation.