ISO 10993-10:2010描述了医疗器械及其组成材料产生刺激和皮肤致敏的可能性评估程序。 ISO 10993-10:2010包括: 刺激性的预试验考虑，包括皮肤暴露的硅内和体外方法； 体内（刺激和致敏）试验程序的详细信息； 解释结果的关键因素。 本手册给出了与上述试验相关的材料制备说明，并对医疗器械在皮肤以外区域的应用进行了几项特殊刺激性试验。

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.