NF EN ISO 10993-10

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.

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National standards and national normative documents

Publication date

December 2013

Number of pages

81 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 - 18/11/2013

International kinship

ISO 10993-10:2010

European kinship

EN ISO 10993-10:2013
Sumary
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.

Replaced standards (1)
NF EN ISO 10993-10
December 2010
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.

Standard replaced by (1)
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    VI
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Principes généraux - Approche par étapes
    4
  • 5 Considérations préalables aux essais
    5
  • 5.1 Généralités
    5
  • 5.2 Types de matériaux
    5
  • 5.3 Informations sur la composition chimique
    6
  • 6 Essais d'irritation
    6
  • 6.1 Essais d'irritation in vitro
    6
  • 6.2 Essais d'irritation in vivo - Facteurs à prendre en considération lors de la conception et du choix des essais in vivo
    7
  • 6.3 Essai d'irritation chez l'animal
    8
  • 6.4 Essai de réactivité intracutanée (intradermique) chez l'animal
    12
  • 6.5 Essai d'irritation de la peau humaine
    15
  • 7 Essais de sensibilisation de la peau
    16
  • 7.1 Choix des méthodes d'essai
    16
  • 7.2 Essai local sur le ganglion lymphatique chez la souris (LLNA)
    16
  • 7.3 Essais sur cobaye pour la détection d'une sensibilisation de la peau
    19
  • 7.4 Facteurs importants permettant d'influencer l'issue de l'essai
    20
  • 7.5 Essai de maximalisation sur cobaye (GPMT)
    21
  • 7.6 Essai sous système occlusif (Essai de Buehler)
    24
  • 8 Facteurs clés pour l'interprétation des résultats d'essai
    27
  • Annexe A (normative) Préparation des matériaux pour les essais d'irritation/de sensibilisation
    28
  • Annexe B (normative) Essais d'irritation particuliers
    30
  • Annexe C (normative) Essai d'irritation de la peau sur l'Homme
    46
  • Annexe D (informative) Essai d'irritation de la peau in vitro
    50
  • Annexe E (informative) Méthode de préparation d'extraits à partir de matériaux d'essai polymériques
    56
  • Annexe F (informative) Informations générales
    59
  • Bibliographie
    63
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