EN ISO 13017:2012

Dentistry - Magnetic attachments (ISO 13017:2012)

ISO 13017:2012 specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of crowns and bridges, removable partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

Zahnheilkunde - Magnetische Retentionselemente (ISO 13017:2012)

Diese Internationale Norm legt Anforderungen und Prüfverfahren für die Bewertung der Anwendbarkeit von dentalen magnetischen Retentionselementen fest, die zur Befestigung, Unterstützung und Stabilisierung von Kronen und Brücken, herausnehmbaren Teilprothesen, Totalprothesen, Suprakonstruktionen auf Dentalimplantaten und kieferorthopädischen oder defektprothetische Versorgungen einschließlich Obturatoren sowie Epithesen verwendet werden.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 10993-1 und ISO 7405 heranzuziehen.

Médecine bucco-dentaire - Attaches magnétiques (ISO 13017:2012)

L'ISO 13017:2012 spécifie les exigences et les méthodes d'essai relatives à l'évaluation de l'applicabilité des attaches magnétiques dentaires qui assurent le maintien, le support et la stabilisation des couronnes, prothèses partielles fixes, prothèses partielles amovibles, prothèses partielles amovibles, prothèses hybrides, superstructures d'implants dentaires et prothèses orthodontiques ou maxillo-faciales, y compris obturateurs.
L'ISO 13017:2012 ne spécifie aucune méthode d'essai qualitative ou quantitative permettant de démontrer l'absence de risques biologiques inacceptables. L'évaluation de ces risques peut être réalisée conformément à l'ISO 10993-1 et à l'ISO 7405.

Zobozdravstvo - Magnetni priključki (ISO 13017:2012)

Ta mednarodni standard določa zahteve in preskusne metode za oceno uporabnosti dentalnih magnetnih priključkov, ki zagotavljajo ohranitev, podporo in stabilizacijo prevlek in mostičkov, odstranljivih delnih zobnih protez, totalnih zobnih protez, nadgradenj dentalnih vsadkov in ortodontske ali maksilofacialne protetike, vključno z obturatorjem. Ta mednarodni standard ne določa kvalitativnih in kvantitativnih preskusnih metod za dokaz neprisotnosti nesprejemljivega biološkega tveganja, ki se lahko oceni na podlagi standardov ISO 10993-1 in ISO 7405.

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2012
• Withdrawal Date: 28-Jul-2020
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 29-Jul-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 13017:2012 - Dentistry - Magnetic attachments (ISO 13017:2012)

Relations

• Replaced By: EN ISO 13017:2020 - Dentistry - Magnetic attachments (ISO 13017:2020)
• Effective Date: 05-Aug-2020
• Amended By: EN ISO 13017:2012/A1:2015 - Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13017:2012
01-oktober-2012
=RER]GUDYVWYR0DJQHWQLSULNOMXþNL,62
Dentistry - Magnetic attachments (ISO 13017:2012)
Zahnheilkunde - Magnetische Retentionselemente (ISO 13017:2012)
Médecine bucco-dentaire - Attaches dentaires magnétiques (ISO 13017:2012)
Ta slovenski standard je istoveten z: EN ISO 13017:2012
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 13017:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13017:2012

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SIST EN ISO 13017:2012


EUROPEAN STANDARD
EN ISO 13017

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2012
ICS 11.060.10
English Version
Dentistry - Magnetic attachments (ISO 13017:2012)
Médecine bucco-dentaire - Attaches magnétiques (ISO Zahnheilkunde - Magnetische Befestigungselemente (ISO
13017:2012) 13017:2012)
This European Standard was approved by CEN on 14 July 2012.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13017:2012: E
worldwide for CEN national Members.

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SIST EN ISO 13017:2012
EN ISO 13017:2012 (E)
Contents Page
Foreword .3

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SIST EN ISO 13017:2012
EN ISO 13017:2012 (E)
Foreword
This document (EN ISO 13017:2012) 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 January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13017:2012 has been approved by CEN as a EN ISO 13017:2012 without any modification.

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SIST EN ISO 13017:2012

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SIST EN ISO 13017:2012
INTERNATIONAL ISO
STANDARD 13017
First edition
2012-07-15
Dentistry — Magnetic attachments
Médecine bucco-dentaire — Attaches magnétiques
Reference number
ISO 13017:2012(E)
©
ISO 2012

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SIST EN ISO 13017:2012
ISO 13017:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in th
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