浅谈适用于医疗器械眼刺激试验的体外替代方法  

Introduction of the Alternative Methods Available to Draize Eye Irritancy Test of Medical Devices

作　　者：田胜慧 柯军[1] 林美琼[1] 颜林[1] 

机构地区：[1]广东省医疗器械质量监督检验所,广州510663

出　　处：《中国医疗器械信息》2015年第6期37-40,69,共5页China Medical Device Information

基　　金：广东省教育部科技部产学研结合项目广东省医疗器械安全评价中心(编号:2011A091000038)

摘　　要：目前,替代方法的研究主要集中在化妆品、化妆品原料等领域,医疗器械领域的相关报道却很少。本文将对体内眼刺激试验的发生机制,目前可供选择的眼刺激试验替代方法,以及其中适用于医疗器械领域的替代方法和有关这方面的研究做简要介绍。At present,the research of alternative methods concentrated in the areas such as cosmetics and the raw materials.However,only a few reports were about the medical devices.We mainly talked about the in vivo mechanism of eye irritation,altermative methods currently available to the Draize eye irritancy test,the alternative methods and researches available to the medical devices.

关 键 词：医疗器械 兔眼刺激试验 替代方法 

分 类 号：R319[医药卫生—基础医学]