NF EN ISO 10993-10

NF EN ISO 10993-10

February 2003
Standard Cancelled

Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2003

Number of pages

62 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

S99-510

Print number

1 - 13/02/2003

International kinship

ISO 10993-10:2002

European kinship

EN ISO 10993-10:2002
Sumary
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.

This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.

Guidance is given in annex A for the preparation of materials specifically in relation to the above tests.

Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B.

Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.

Replaced standards (1)
NF EN ISO 10993-10
March 1996
Standard Cancelled
Biological evaluation of medical devices. Part 10 : tests for irritation and sensitization.

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
    4
  • 5.1 Généralités
    4
  • 5.2 Types de matériaux
    4
  • 5.3 Informations sur la composition chimique
    5
  • 5.4 Caractérisation du matériau
    5
  • 6 Essais d'irritation
    6
  • 6.1 Essai d'irritation in vitro
    6
  • 6.2 Facteurs à prendre en considération lors de la conception et du choix des essais in vivo
    6
  • 6.3 Essai d'irritation cutanée chez l'Animal
    7
  • 6.4 Essai d'irritation de la peau sur l'Homme
    11
  • 7 Essais d'hypersensibilité retardée
    15
  • 7.1 Choix des essais
    15
  • 7.2 Choix des concentrations du matériau d'essai
    15
  • 7.3 Autres facteurs importants permettant d'influencer l'issue de l'essai
    16
  • 7.4 Essai d'hypersensibilité retardée par maximalisation
    16
  • 7.5 Essai avec système occlusif permettant de déterminer l'hypersensibilité retardée
    20
  • 8 Facteurs clés pour l'interprétation du résultat d'essai
    22
  • Annexe A (normative) Préparation des matériaux pour les essais d'irritationide sensibilisation
    23
  • Annexe B (informative) Essais d'irritation supplémentaires
    25
  • Annexe C (informative) Informations générales
    44
  • Bibliographie
    48
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