EN ISO 10451:2010

Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.

Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO 10451:2010)

Diese Internationale Norm legt Anforderungen an den Inhalt der Technischen Dokumentation fest, die erstellt
wird, um die Erfüllung der Zulassungsanforderungen für ein Dentalimplantat und alle dazugehörigen
vorgefertigten Teile nachzuweisen, die nach dem zahnärztlichen Eingriff im Mund verbleiben.
Diese Internationale Norm gilt nicht für Instrumente und andere Teile, die speziell für ein Dentalimplantatsystem
hergestellt wurden, aber nicht im Mund verbleiben. Trotzdem kann die Dokumentation zu diesen
Komponenten in die Technische Dokumentation eingefügt werden.

Médecine bucco-dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO 10451:2010)

L'ISO 10451:2010 spécifie les exigences relatives au contenu du dossier technique afin de démontrer que tout implant dentaire, y compris ses constituants préfabriqués destinés à rester dans la bouche après intervention chirurgicale, satisfait aux exigences réglementaires.

Zobozdravstvo - Vsebina tehnične mape za sistem zobnih vsadkov (implantatov) (ISO 10451:2010)

Ta mednarodni standard določa zahteve za vsebino tehnične mape, ki prikazuje izpolnjevanje regulativnih zahtev za zobni vsadek in njegove tovarniško izdelane dele, ki po posegu ostanejo v ustih. Ta mednarodni standard ne velja za instrumente in druge dele, ki so narejeni posebej za sistem zobnih vsadkov, vendar ne ostanejo v ustih. Dokumentacija v zvezi s temi sestavnimi deli pa se lahko vključi v tehnično mapo.

General Information

• Status: Published
• Publication Date: 14-Jun-2010
• Withdrawal Date: 30-Dec-2010
• ICS: 11.060.10 - Dental materials
• ICS: 11.060.15 - Dental implants
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Jun-2010
• Completion Date: 15-Jun-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 10451:2010 - Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

Relations

• Replaces: EN ISO 10451:2002 - Dental implant systems - Contents of technical file (ISO 10451:2002)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10451:2010
01-oktober-2010
1DGRPHãþD
SIST EN ISO 10451:2002
=RER]GUDYVWYR9VHELQDWHKQLþQHPDSH]DVLVWHP]REQLKYVDGNRYLPSODQWDWRY
,62
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
Zahnheilkunde - Inhalt der Technischen Dokumentation für Dentalimplantatsysteme (ISO
10451:2010)
Art dentaire - Contenu du dossier technique pour les systèmes d'implants dentaires (ISO
10451:2010)
Ta slovenski standard je istoveten z: EN ISO 10451:2010
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 10451:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10451:2010

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SIST EN ISO 10451:2010


EUROPEAN STANDARD
EN ISO 10451

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2010
ICS 11.060.15
English Version
Dentistry - Contents of technical file for dental implant systems
(ISO 10451:2010)
Médecine bucco-dentaire - Contenu du dossier technique Zahnheilkunde - Inhalt der Technischen Dokumentation für
pour les systèmes d'implants dentaires (ISO 10451:2010) Dentalimplantatsysteme (ISO 10451:2010)
This European Standard was approved by CEN on 26 May 2010.

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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10451:2010: E
worldwide for CEN national Members.

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SIST EN ISO 10451:2010
EN ISO 10451:2010 (E)
Contents Page
Foreword .3

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SIST EN ISO 10451:2010
EN ISO 10451:2010 (E)
Foreword
This document (EN ISO 10451:2010) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in
collaboration with 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 2010, and conflicting national standards shall be withdrawn
at the latest by December 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10451:2002.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10451:2010 has been approved by CEN as a EN ISO 10451:2010 without any modification.

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SIST EN ISO 10451:2010

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SIST EN ISO 10451:2010

INTERNATIONAL ISO
STANDARD 10451
Second edition
2010-06-15

Dentistry — Contents of technical file for
dental implant systems
Médecine bucco-dentaire — Contenu du dossier technique pour les
systèmes d'implants dentaires




Reference number
ISO 10451:2010(E)
©
ISO 2010

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SIST EN ISO 10451:2010
ISO 10451:2010(E)
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