20/30377819 DC

This standard 20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

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 sensitization test procedures;

• key factors for the interpretation of the results.