BS EN ISO 10993-23:2021

This standard BS EN ISO 10993-23:2021 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 produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

• pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

• details of in vitro and in vivo irritation test procedures;

• key factors for the interpretation of the results.