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.
Status: PublishedPublication date: 2021-01
Corrected version (fr): 2021-02
Edition: 1Number of pages: 60
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
Buy this standard
|std 1 187||PDF + ePub|
|std 2 187||Paper|
ISO 10993-23:2021Stage: 60.60
Got a question?
Check out our FAQs
+41 22 749 08 88
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.