NF EN ISO 7405

NF EN ISO 7405

November 2018
Standard Current

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

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.This document 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

November 2018

Number of pages

55 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

International kinship

ISO 7405:2018

European kinship

EN ISO 7405:2018
Sumary
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

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.

This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Replaced standards (2)
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.

NF EN ISO 7405/A1
September 2013
Standard Cancelled
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1 : positive control material

Le présent document spécifie des méthodes d'essai pour l'évaluation des effets biologiques des dispositifs médicaux utilisés en art dentaire. Il inclut des essais de produits pharmacologiques qui font partie intégrante du dispositif en cours d'essai. Le présent document ne couvre pas les essais des matériaux et des dispositifs qui n'entrent pas en contact direct ou indirect avec le corps du patient.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Classification des dispositifs médicaux
  • 5 Processus d'évaluation biologique
  • 6 Modes opératoires d'essai spécifiques des matériaux dentaires
  • Annexe A Types d'essais à prendre en compte pour évaluer la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire
  • Annexe B Essai de cytotoxicité de la barrière dentinaire
  • Annexe C Essai d'utilisation des implants dentaires endo-osseux
  • Bibliographie
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