NF EN ISO 10993-5

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.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2010

Number of pages

44 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

S99-501-5

Print number

1 - 30/06/2010

International kinship

ISO 10993-5:2009

European kinship

EN ISO 10993-5:2009
Sumary
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.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Préparation des échantillons et des contrôles
    2
  • 4.1 Généralités
    2
  • 4.2 Préparation des extraits liquides de matériau
    3
  • 4.3 Préparation du matériau pour les essais en contact direct
    4
  • 4.4 Préparation des contrôles
    5
  • 5 Lignées cellulaires
    5
  • 6 Milieu de culture
    6
  • 7 Préparation de la culture cellulaire mère
    6
  • 8 Modes opératoires d'essai
    6
  • 8.1 Nombre d'exemplaires
    6
  • 8.2 Essais à partir d'extraits
    6
  • 8.3 Essai par contact direct
    7
  • 8.4 Essai par contact indirect
    8
  • 8.5 Détermination de la cytotoxicité
    9
  • 9 Rapport d'essai
    11
  • 10 Interprétation des résultats
    11
  • Annexe A (informative) Essai de cytotoxicité par fixation du rouge neutre (NRU)
    12
  • Annexe B (informative) Essai de cytotoxicité par formation de colonies
    19
  • Annexe C (informative) Essai de cytotoxicité au MTT
    24
  • Annexe D (informative) Essai de cytotoxicité au XTT
    29
  • Bibliographie
    34
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