SIST EN 1642:2005

Dentistry - Medical devices for dentistry - Dental implants

This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate

Diese Europäische Norm legt allgemeine Anforderungen an Dentalimplantate fest. Chirurgische implantierbare zahnärztliche Werkstoffe, definiert als restaurative Werkstoffe, sind insbesondere ausgeschlossen und werden in EN 1641 beschrieben.
Diese Norm legt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und die Informationen durch den Hersteller fest.

Art dentaire - Dispositifs médicaux pour l'art dentaire - Implants dentaires

La présente Norme européenne établit les exigences générales relatives aux implants dentaires. Les produits dentaires chirurgicalement implantables, qui relevent de la définition des produits de restauration, sont spécifiquement exclus. Ils sont décrits dans l'EN 1641.
La présente Norme européenne établit les exigences générales relatives a la performance attendue, aux caractéristiques de conception, aux composants, a la stérilisation, a l'emballage, au marquage, a l'étiquetage ainsi qu'aux informations fournies par le fabricant.

Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Dentalni vsadki (implantati)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-2004
• Withdrawal Date: 19-Nov-2009
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Nov-2009
• Due Date: 13-Dec-2009
• Completion Date: 20-Nov-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 1642:2004 - Dentistry - Medical devices for dentistry - Dental implants

Relations

• Replaced By: SIST EN 1642:2010 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 01-Jan-2010
• Replaces: SIST EN 1642:2000 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 01-Jan-2005

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1642:2005
01-januar-2005
1DGRPHãþD
SIST EN 1642:2000
=RER]GUDYVWYR0HGLFLQVNLSULSRPRþNL]D]RER]GUDYVWYR'HQWDOQLYVDGNL
LPSODQWDWL
Dentistry - Medical devices for dentistry - Dental implants
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate
Art dentaire - Dispositifs médicaux pour l'art dentaire - Implants dentaires
Ta slovenski standard je istoveten z: EN 1642:2004
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN 1642:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1642:2005

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SIST EN 1642:2005
EUROPEAN STANDARD
EN 1642
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.060.15 Supersedes EN 1642:1996
English version
Dentistry - Medical devices for dentistry - Dental implants
Art dentaire - Dispositifs médicaux pour l'art dentaire - Zahnheilkunde - Medizinprodukte für die Zahnheilkunde -
Implants dentaires Dentalimplantate
This European Standard was approved by CEN on 17 March 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1642:2004: E
worldwide for CEN national Members.

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SIST EN 1642:2005
EN 1642:2004 (E)
Contents
page
Foreword.3
1 Scope.5
2 Normative references.5
3 Terms and definitions .6
4 Requirements.6
4.1 General.6
4.2 Design and properties.6
4.3 Control of contamination .6
4.3.1 General.6
4.3.2 Dental implants supplied sterile.6
4.3.3 Dental implants supplied non-sterile.7
4.3.4 Dental implants which incorporate materials of animal origin .7
4.4 Dental implants used in combination.7
4.5 Clinical investigation.7
4.6 Marking, labelling and information supplied by the manufacturer .7
4.6.1 General.7
4.6.2 Symbols.7
4.6.3 Labelling.7
4.6.4 Instructions for use .8
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC.9
Bibliography .10
2

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SIST EN 1642:2005
EN 1642:2004 (E)
Foreword
This document (EN 1642:2004) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat
of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by December 2004, and conflicting national standards shall be withdrawn at the latest
by December 2004.
This document supersedes EN 1642:1996.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC.
For relationship with EU Directive 93/42/EEC, see informative annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
3

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SIST EN 1642:2005
EN 1642:2004 (E)
Introduction
There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows:
— Level 1: General requirements for medical devices;
— Level 2: Particular requirements for families of medical devices used in dentistry;
— Level 3: Specific requirements for types of medical devices used in dentistry.
There are no level 1 standards written exclusively in respect of medical devices used in dentistry.
This standard is a level 2 standard and details requirements that apply to dental implants (for surgically implantable
dental materials included within the definition of restorative materials see EN 1641). It is also indicated that there
are additional requirements in the level 3 standards. Where available, these are included as normative references.
To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level.
In the Bibliography a reference for guidance on the classification of dental devices and accessories [4] is given.
4

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SIST EN 1642:2005
EN 1642:2004 (E)
1 Scope
This European Standard specifies general requirements for dental implants. Surgically implantable dental materials
defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components,
sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 550, Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization.
EN 552, Sterilization of medical devices — Validation and routine control of sterilization by irradiation.
EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" —
Part 1: Requirements for terminally sterilized medical devices.
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1041, Information supplied by the manufacturer
...