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SSH EN ISO 10993-23:2021

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

Aug 14, 2024

General information

60.60     Aug 14, 2024

DPS

DPS/KT 206

European Norm

11.100.20  

English  

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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.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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Life cycle

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PUBLISHED
SSH EN ISO 10993-23:2021
60.60 Standard published
Aug 14, 2024

Related project

Adopted from EN ISO 10993-23:2021