ISO/TS 11796

Abstract

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

General information

Status
: Under development
Edition
: 1
Technical Committee
: ISO/TC 194 Biological and clinical evaluation of medical devices
ICS
:
11.100.20 Biological evaluation of medical devices