BS EN ISO10993-10-2002 医疗器械的生物评定.刺激与持续过敏症试验

标准号：BS EN ISO10993-10-2002
中文标准名称：医疗器械的生物评定.刺激与持续过敏症试验
英文标准名称：Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
标准类型：C04
发布日期：2002/10/8 12:00:00
实施日期：2002/10/8 12:00:00
中国标准分类号：C04
国际标准分类号：11.100.20
适用范围：This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.