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
Status: Under development
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
This standard contributes to the following Sustainable Development Goal:
ISO/TS 11796Stage: 60.00 (Under publication)
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