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DIN EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
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.
Deutsches Institut für Normung [din]