NF EN ISO 10993-3

NF EN ISO 10993-3

December 2014
Standard Current

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

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:genotoxicity;carcinogenicity;reproductive and developmental toxicity.ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

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Collections

National standards and national normative documents

Publication date

December 2014

Number of pages

49 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

S99-501-3

Print number

1

International kinship

ISO 10993-3:2014

European kinship

EN ISO 10993-3:2014
Sumary
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

  • genotoxicity;
  • carcinogenicity;
  • reproductive and developmental toxicity.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Replaced standards (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 Exigences applicables aux stratégies d'essais
    2
  • 5 Essais de génotoxicité
    4
  • 6 Essais de cancérogénicité
    7
  • 7 Essais concernant la toxicité sur la reproduction et le développement
    10
  • 8 Rapport d'essai
    12
  • Annexe A (informative) Lignes directrices pour le choix d'un mode opératoire de préparation des échantillons pour essai appropriés pour les essais de génotoxicité
    13
  • Annexe B (informative) Logigramme relatif à l'évaluation de suivi
    23
  • Annexe C (informative) Justification des systèmes d'essai
    24
  • Annexe D (informative) Systèmes d'essai de transformation cellulaire
    26
  • Annexe E (normative) Prise en compte des études de cancérogénicité effectuées en tant qu'études d'implantation
    27
  • Annexe F (informative) Essais d'embryotoxicité in vitro
    28
  • Bibliographie
    30
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