NF EN ISO 10993-10

March 1996

Standard Cancelled

Biological evaluation of medical devices. Part 10 : tests for irritation and sensitization.

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Main informations

Collections

National standards and national normative documents

Publication date

March 1996

Number of pages

41 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 - mars 1996

International kinship

ISO 10993-10:1995

European kinship

EN ISO 10993-10:1995

Standard replaced by (1)

NF EN ISO 10993-10

January 2003

Standard Cancelled

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

Table of contents

1 Domaine d'application
1
2 Références normatives
1
3 Définitions
1
4 Principes généraux, approche par étapes
2
5 Essais d'irritation
2
5.1 Facteurs à prendre en considération lors de la conception et du choix des essais
2
5.2 Essai d'irritation de la peau
3
5.3 Essai d'irritation oculaire
6
5.4 Essai de réactivité intracutanée (intradermique)
8
6 Essais de sensibilisation
10
6.1 Facteurs à prendre en considération lors de la conception et du choix des essais
10
6.2 Essai de maximisation de sensibilisation
11
6.3 Essai de sensibilisation avec système occlusif
13
Annexes
A Préparation des matériaux pour les essais
16
B Méthode d'extraction des matériaux pour les essais biologiques
17
C Les animaux et leur élevage
19
D Essais d'irritation supplémentaires
20
E Informations générales
28
F Bibliographie
31

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