NF EN ISO 10993-10

NF EN ISO 10993-10

February 2023
Standard Current

Biological evaluation of medical devices - Part 10 : tests for skin sensitization

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.This document includes:—    details of in vivo skin sensitization test procedures;—    key factors for the interpretation of the results.NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

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National standards and national normative documents

Publication date

February 2023

Number of pages

61 p.

Reference

NF EN ISO 10993-10

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-10

Print number

1

International kinship

ISO 10993-10:2021

European kinship

EN ISO 10993-10:2023
Sumary
Biological evaluation of medical devices - Part 10 : tests for skin sensitization

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

—    details of in vivo skin sensitization test procedures;

—    key factors for the interpretation of the results.

NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Replaced standards (1)
NF EN ISO 10993-10
December 2013
Standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes généraux - Approche par étapes
  • 5 Considérations préalables aux essais
  • 6 Essais de sensibilisation cutanée
  • 7 Facteurs clés pour l'interprétation des résultats d'essai
  • Annexe A (normative) Préparation des matériaux pour les essais de sensibilisation cutanée
  • Annexe B (informative) Méthode de préparation d'extraits à partir de matériaux d'essai polymériques
  • Annexe C (informative) Méthodes non-animales pour la sensibilisation cutanée
  • Annexe D (informative) Informations générales sur les essais de sensibilisation permettant de déterminer la sensibilisation cutanée
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
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