FD CEN/TR 12401

FD CEN/TR 12401

November 2009
Published document Current

Dentistry - Guidance on the classification of dental devices and accessories

Le présent document fournit des recommandations concernant l'application des règles de classification données dans la Directive 93/42/CEE du Conseil du 14 juin 1993, amendée par la Directive 2007/47/CE, sur les dispositifs médicaux utilisés en art dentaire et leurs accessoires.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2009

Number of pages

12 p.

Reference

FD CEN/TR 12401

ICS Codes

11.060.01   Dentistry in general

Classification index

S91-002

Print number

1 - 14/12/2009

European kinship

CEN/TR 12401:2009
Sumary
Dentistry - Guidance on the classification of dental devices and accessories

Le présent document fournit des recommandations concernant l'application des règles de classification données dans la Directive 93/42/CEE du Conseil du 14 juin 1993, amendée par la Directive 2007/47/CE, sur les dispositifs médicaux utilisés en art dentaire et leurs accessoires.
Replaced standards (1)
FD CEN/TR 12401
September 2003
Published document Cancelled
Dentistry - Guidance on the classification of dental devices and accessories

Le présent document fournit les recommandations relatives aux règles de classification données dans la Directive 93/42/CEE du 14 juin 1993 sur les dispositifs médicaux. Il apporte une aide au fabricant ou à son mandataire dans la classification d'un dispositif, dans le cadre de la préparation de son dossier en vue de l'obtention du marquage CE.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Classification des dispositifs dentaires et de leurs accessoires
    4
  • 3 Propositions de classification des dispositifs dentaires et des accessoires
    5
  • Bibliographie
    10
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