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. The OECD methods can be evaluated as is or, if necessary, after being adapted to test medical devices. This document includes consideration on the: - Database of reference chemical sensitizers and non-sensitizers - reference materials - Prevalidation of candidate methods - Interlaboratory study o Samples preparation and coding o Spiking of the extracts of negative reference material o Collection of the data o Statistical analysis to assess the reliability and reproducibility