NF EN ISO 10993-5

December 1999

Standard Cancelled

Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity

La présente partie de l'ISO 10993 décrit des méthodes d'essai pour mesurer la cytotoxicité in vitro des dispositifs médicaux.Ces méthodes spécifient l'incubation de cellules en culture soit directement, soit par diffusion:a) avec des extraits du dispositif, et/oub) en contact direct avec le dispositif.Ces méthodes sont destinées à déterminer la réponse biologique de cellules de mammifères in vitro, à l'aide de paramètres biologiques appropriés.

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Main informations

Collections

National standards and national normative documents

Publication date

December 1999

Number of pages

18 p.

Reference

NF EN ISO 10993-5

ICS Codes

11.040.01 Medical equipment in general

11.100.20 Biological evaluation of medical devices

Classification index

S99-505-5

Print number

1 - 01/10/2004

International kinship

ISO 10993-5:1999

European kinship

EN ISO 10993-5:1999

Sumary

Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity

Replaced standards (1)

NF EN 30993-5

November 1994

Standard Cancelled

Biological evaluation of medical devices. Part 5 : tests for cytotoxicity : in vitro methods.

Le présent document donne des méthodes d'essai pour mesurer la cytotoxicité des matériaux et dispositifs. L'incubation des cellules en culture est notamment décrite.

Standard replaced by (1)

NF EN ISO 10993-5

July 2010

Standard Current

Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Table of contents

1 Domaine d'application
1
2 Références normatives
1
3 Termes et définitions
1
4 Préparation des échantillons
3
5 Lignées cellulaires
4
6 Milieu de culture
5
7 Préparation de la culture-stock cellulaire
5
8 Modes opératoires d'essai
5
9 Rapport d'essai
9
10 Interprétation des résultats
9

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