Βιολογική αξιολόγηση προϊόντων για ιατρική χρήση - Μέρος 10: Δοκιμές για δερματική ευαισθητοποίηση

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —    details of in vivo skin sensitization test procedures; —    key factors for the interpretation of the results. NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.