Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation

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.

Content Provider
International Organization for Standardization [iso]

Others Also Bought

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Document History
We have no document history for this standard.
Included in Packages
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.