EN 1642:2004

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 relèvent 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 à la performance attendue, aux caractéristiques de conception, aux composants, à la stérilisation, à l'emballage, au marquage, à l'étiquetage ainsi qu'aux informations fournies par le fabricant.

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

General Information

• Status: Withdrawn
• Publication Date: 01-Jun-2004
• Withdrawal Date: 27-Oct-2009
• ICS: 11.060.15 - Dental implants
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 28-Oct-2009
• Completion Date: 28-Oct-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: SIST EN 1642:2005 - Dentistry - Medical devices for dentistry - Dental implants

Relations

• Replaces: EN 1642:1996 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 22-Dec-2008
• Replaced By: EN 1642:2009 - Dentistry - Medical devices for dentistry - Dental implants
• Effective Date: 31-Oct-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1642:2005
01-januar-2005
1DGRPHãþD
SIST EN 1642:2000
=RER]GUDYVWYR0HGLFLQVNLSULSRPRþNL]D]RER]GUDYVWYR'HQWDOQLYVDGNL
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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.
...