GSO ISO 10993-23:2024
Gulf Standard
Current Edition
·
Approved on
25 April 2024
·
Biological evaluation of medical devices — Part 23: Tests for irritation
GSO ISO 10993-23:2024 Files
English
60 Pages
Current Edition
Reference Language
86.68 BHD
GSO ISO 10993-23:2024 Scope
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.
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