PD ISO/TS 11796:2023 PDF

1   Scope This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses:

— the database of reference chemical skin sensitizers and non-skin sensitizers ;

— reference materials;

— feasibility testing of candidate test methods , including any method optimization for use with extracts of medical devices;

— prevalidation of candidate test methods ;

— the interlaboratory study :

— sample preparation and coding;

— spiking of the extracts from the negative control medical device material;