Abstract

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 10993-12.

Begin

2023-11-14

WI

00206105

Planned document number

DIN EN ISO 10993-23/A1

Project number

02703416

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 8 - Irritation, sensitization  

draft standard

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024
2024-10
Order from DIN Media

previous edition(s)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
2021-10

Order from DIN Media