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SSH EN ISO 10993-23:2021

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 23: Testet për irritimin (ISO 10993-23:2021)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
14 gush 2024

General information

60.60     14 gush 2024

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

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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

Pajisjet mjekësore aktive transplatuese

93/42/EEC

Pajisje Mjekësore

2017/745

Të harmonizuara

Life cycle

NOW

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

Related project

Adopted from EN ISO 10993-23:2021