NF EN ISO 10993-10
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)

Le présent document décrit le mode opératoire pour l''évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation et une sensibilisation de la peau. Il comprend : des considérations préalablement aux essais relatives à l''irritation, y compris des méthodes in silice, et in vitro d''exposition dermique; des informations détaillées relatives aux procédures d''essai in vivo (irritation et sensibilisation), et des facteurs clés pour l''interprétation des résultats. Le présent document vient à l''appui des exigences essentielles des Directives Nouvelles approches 93/42/CEE relative aux dispositifs médicaux et 90/385/CEE relative aux dispositifs médicaux implantables actifs.

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Main informations

Collections

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

Print number

1 - novembre 2013

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)

Le présent document décrit le mode opératoire pour l''évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation et une sensibilisation de la peau. Il comprend : des considérations préalablement aux essais relatives à l''irritation, y compris des méthodes in silice, et in vitro d''exposition dermique; des informations détaillées relatives aux procédures d''essai in vivo (irritation et sensibilisation), et des facteurs clés pour l''interprétation des résultats. Le présent document vient à l''appui des exigences essentielles des Directives Nouvelles approches 93/42/CEE relative aux dispositifs médicaux et 90/385/CEE relative aux dispositifs médicaux implantables actifs.
Replaced standards (1)
NF EN ISO 10993-10
NF EN ISO 10993-10
January 2010
Standard Cancelled
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

Standard replaced by (1)
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

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