描述了评估医疗器械及其组成材料产生刺激和皮肤致敏的可能性的程序。包括:a）刺激性的预测试考虑，包括皮肤暴露的硅胶和体外方法；b） 体内（刺激和致敏）试验程序的详细信息，以及；c） 解释结果的关键因素。附录A中给出了与上述试验相关的材料制备说明。 附录B中描述了医疗器械在皮肤以外区域应用的几种特殊刺激试验。

Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. Includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.