ISO/DTS 11796

Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

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