ISO 10993-23:2021 PDF

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 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.

ISO 10993-23:2021 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice

2021 ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation