Abstract

This Uganda Standard describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This 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; c) key factors for the interpretation of the results. (This standard cancels and replaces US ISO 10993-10:2002 which has been technically revised). This standard was PUBLISHED on 2019-10-01.