NF EN ISO 10993-10/A1

NF EN ISO 10993-10/A1

October 2006
Standard Cancelled

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

Le présent document apporte des précisions et/ou modifications sur certaines parties de la norme NF EN ISO 10993 de février 2003.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2006

Number of pages

10 p.

Reference

NF EN ISO 10993-10/A1

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-510/A1

Print number

2 - 01/11/2006

International kinship

ISO 10993-10/A1:2006

European kinship

EN ISO 10993-10/A1:2006
Sumary
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

Le présent document apporte des précisions et/ou modifications sur certaines parties de la norme NF EN ISO 10993 de février 2003.
Standard replaced by (1)
NF EN ISO 10993-10
September 2009
Standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

Le présent document décrit le mode opératoire visant à évaluer le potentiel des dispositifs médicaux et leurs matériaux constitutifs à provoquer de l'irritation et une hypersensibilité retardée. Les normes de la série EN ISO 10993 sur l'évaluation biologique des dispositifs médicaux ont le statut de normes harmonisées et viennent en appui aux Directives européennes sur les dispositifs médicaux. Les Directives 93/42/CE sur les dispositifs médicaux et 90/385CE sur les dispositifs médicaux implantables actifs ayant été modifiées par la Directive 2007/47/CE il a été nécessaire de préparer des nouvelles versions des annexes ZA et ZB donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées.

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