International Standard
ISO 10993-23:2021
Biological evaluation of medical devices — Part 23: Tests for irritation
Reference number
ISO 10993-23:2021
Edición 1
2021-01
© ISO 2024
International Standard
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No disponible en español
Publicado (Edición 1, 2021)

ISO 10993-23:2021

Formato
Idioma
CHF 194
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Resumen

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.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2021-01
    Versión corregida (fr)
     : 2021-02
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 1
    Número de páginas
     : 60
  • Comité Técnico :
    ISO/TC 194
    ICS :
    11.100.20 
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