SIST-TP CEN/TR 12401:2003

SLOVENSKI STANDARD
SIST-TP CEN/TR 12401:2003
01-november-2003
1DGRPHãþD
SIST CR 12401:2000
=RER]GUDYVWYR±1DSRWNL]DUD]YUãþDQMH]RER]GUDYVWYHQLKQDSUDYLQSULSRPRþNRY
Dentistry - Guidance on the classification of dental devices and accessories
Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehör
Art dentaire - Guide de classification des dispositifs dentaires et accessoires
Ta slovenski standard je istoveten z: CEN/TR 12401:2003
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
SIST-TP CEN/TR 12401:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 12401:2003

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SIST-TP CEN/TR 12401:2003
TECHNICAL REPORT
CEN/TR 12401
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2003
ICS 11.060.20 Supercedes CR 12401:1996
English version
Dentistry - Guidance on the classification of dental devices and
accessories
Art dentaire - Guide de classification des dispositifs Zahnheilkunde - Anleitung zur Klassifizierung von
dentaires et accessoires Dentalprodukten und Zubehör
This Technical Report was approved by CEN on 12 January 2003. It has been drawn up by the Technical Committee CEN/TC 055.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 12401:2003 E
worldwide for CEN national Members.

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SIST-TP CEN/TR 12401:2003
CEN/TR 12401:2003 (E)
Contents
Foreword.3
Introduction .4
1 Scope .5
2 Classification of dental devices and accessories .5
3 Proposals for classification of dental devices.5
Bibliography .10
Tables
Table 1 — Invasive devices used in the oral cavity. 5
Table 2 — Invasive devices used in the oral cavity by the patient . 8
Table 3 — Non invasive devices. 8
Table 4 — Instruments. 8
Table 5 — Equipment . 9
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SIST-TP CEN/TR 12401:2003
CEN/TR 12401:2003 (E)
Foreword
This document (CEN/TR 12401:2003) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the
secretariat of which is held by DIN.
This document supersedes CEN/CR 12401:1996.
The responsible working group is CEN/TC 55/WG 3 "Classification" (secretariat: NIOM), representing the dental
trade and industry, the dental profession and notified bodies.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
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SIST-TP CEN/TR 12401:2003
CEN/TR 12401:2003 (E)
Introduction
Dental products are marketed for long term, short term and transient use in the mouth. A large number of items
have been developed to assist in the treatment and prevention of oral diseases and the handling of dental
materials. In contrast to pharmaceuticals (medicinal products), many dental materials are intended to perform as
implanted devices in the oral cavity with a minimum of degradation and release of substances, i.e. their main action
is to replace lost and defective teeth and oral tissue. Some materials contain elements that may initiate toxic or
allergic responses. Other materials have additions of medicinal substances.
Many dental materials, instruments, equipment and disposables are covered by the Council Directive 93/42 EEC of
14 June 1993 concerning medical devices. The Directive also provides rules for the classification of medical
devices based on risk and intended use. It is the manufacturer’s responsibility to classify the product according to
the rules of the Directive.
The classification should be acceptable to Notified Bodies (NB) and Competent Authorities (CA). The Directive
describes procedures for resolving any disputes over classification between manufacturers, Notified Bodies and
Competent Authorities.
The European Commission has developed a document ”Guidelines for the Classification of Medical Devices”. This
CEN Technical Report is intended to complement that guidance. In addition, NB-MED, European Co-ordination of
Notified Bodies, have developed a series of consensus statements which also have been taken into consideration.
It will, therefore, be of value to manufacturers in making decisions with regard to the likely classification of particular
devices.
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SIST-TP CEN/TR 12401:2003
CEN/TR 12401:2003 (E)
1 Scope
This CEN Technical Report provides guidance on the application of the classification rules in Council Directive
93/42 EEC of 14 June 1993 concerning medical devices as they pertain to dental devices and accessories.
2 Classification of dental devices and accessories
The list of dental devices and accessories given in Tables 1 to 5 should not necessarily be considered exhaustive.
The classification is based on the most commonly accepted form and intended use of the devices and accessories
listed. If a manufacturer proposes another intended use, the classification of the product may need to be
reconsidered.
Materials and other prefabricated devices that will be part of a custom made device are included in this guidance
document. Custom made devices are not. Some materials can be used both for long term and short term custom
made devices. The intended purpose claimed by the manufacturer will then be decisive for the classification. In this
document the implementing rule 2.5 of the Directive has been used for the proposed classification, i.e. ”the strictest
rules.shal
...