NF EN ISO 10993-3

NF EN ISO 10993-3

August 2004
Standard Cancelled

Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Guidance on selection of tests is provided in ISO 10993-1.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2004

Number of pages

27 p.

Reference

NF EN ISO 10993-3

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-503

Print number

1 - 23/09/2004

International kinship

ISO 10993-3:2003

European kinship

EN ISO 10993-3:2003
Sumary
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.

ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

Guidance on selection of tests is provided in ISO 10993-1.

Replaced standards (1)
NF EN 30993-3
April 1994
Standard Cancelled
Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.

Standard replaced by (1)
NF EN ISO 10993-3
December 2009
Standard Cancelled
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Guidance on selection of tests is provided in ISO 10993-1.

Table of contents
  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Essais de génotoxicité
    3
  • 4.1 Généralités
    3
  • 4.2 Stratégie d'essai
    3
  • 4.3 Préparation des échantillons
    4
  • 4.4 Méthodes d'essai
    4
  • 5 Essais de cancérogénicité
    5
  • 5.1 Généralités
    5
  • 5.2 Stratégie d'essai
    5
  • 5.3 Préparation des échantillons
    5
  • 5.4 Méthodes d'essai
    6
  • 6 Essais concernant la toxicité sur la reproduction et le développement
    6
  • 6.1 Généralités
    6
  • 6.2 Stratégie d'essai
    6
  • 6.3 Préparation des échantillons
    7
  • 6.4 Méthodes d'essai
    7
  • 7 Rapport d'essai
    7
  • Annexe A (informative) Système d'essai de transformation cellulaire
    8
  • Annexe B (informative) Justification des systèmes d'essai
    9
  • Annexe C (informative) Rôle des études de cancérogénicité par implantation
    11
  • Bibliographie
    13
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