NF EN ISO 7405

NF EN ISO 7405

February 2009
Standard Cancelled

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2009

Number of pages

46 p.

Reference

NF EN ISO 7405

ICS Codes

11.060.10   Dental materials
11.100.20   Biological evaluation of medical devices

Classification index

S91-224

Print number

1 - 23/02/2009

International kinship

ISO 7405:2008

European kinship

EN ISO 7405:2008
Sumary
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Replaced standards (1)
NF EN ISO 7405
April 1998
Standard Cancelled
Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials

Standard replaced by (1)
NF EN ISO 7405
November 2018
Standard Current
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

<p>This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.</p> <p>This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Catégorisation des dispositifs médicaux
    3
  • 4.1 Catégorisation en fonction de la nature du contact
    3
  • 4.2 Catégorisation en fonction de la durée du contact
    3
  • 5 Processus d'évaluation biologique
    4
  • 5.1 Généralités
    4
  • 5.2 Sélection des essais et évaluation générale
    4
  • 5.3 Sélection des méthodes d'essai
    5
  • 5.4 Type d'essai
    5
  • 5.5 Réévaluation de la biocompatibilité
    6
  • 6 Méthodes d'essai spécifiques aux produits dentaires
    6
  • 6.1 Recommandations pour la préparation de l'échantillon
    6
  • 6.2 Essai de diffusion sur gélose
    8
  • 6.3 Essai par diffusion sur filtre
    11
  • 6.4 Essai pour la pulpe et la dentine
    14
  • 6.5 Essai de coiffage pulpaire
    18
  • 6.6 Essai d'usage endodontique
    20
  • Annexe A (informative) Types d'essai à prendre en compte pour évaluer la biocompatibilité des dispositifs médicaux utilisés en art dentaire
    24
  • Annexe B (informative) Essai de cytotoxicité de la barrière dentinaire
    26
  • Annexe C (informative) Essai de toxicité aiguë
    34 Bibliographie 35
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