EN ISO 13017:2020

Dentistry - Magnetic attachments (ISO 13017:2020)

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

Zahnheilkunde - Magnetische Befestigungen (ISO 13017:2020)

Dieses Dokument legt Anforderungen und Prüfverfahren zur Bewertung der Anwendbarkeit von dentalen magnetischen Befestigungen fest, die zur Retention, Abstützung und Stabilisierung von herausnehmbaren Prothesen (Kronen und Brücken, Teilprothesen und Totalprothesen), als Suprakonstruktionen auf Dentalimplantaten und kieferorthopädischen oder defektprothetische Versorgungen einschließlich Obturatoren verwendet werden.

Médecine bucco-dentaire - Attaches magnétiques (ISO 13017:2020)

Le présent document 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 prothèses amovibles (couronnes et prothèses partielles fixes, prothèses partielles et prothèses hybrides), des superstructures d'implants dentaires et des appareils orthodontiques ou maxillo-faciaux, y compris les obturateurs.

Zobozdravstvo - Magnetni priključki (ISO 13017:2020)

General Information

• Status: Published
• Publication Date: 28-Jul-2020
• Withdrawal Date: 30-Jan-2021
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Jul-2020
• 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 13017:2020 - Dentistry - Magnetic attachments (ISO 13017:2020)

Relations

• Replaces: EN ISO 13017:2012 - Dentistry - Magnetic attachments (ISO 13017:2012)
• Effective Date: 05-Aug-2020
• Replaces: EN ISO 13017:2012/A1:2015 - Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)
• Effective Date: 05-Aug-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2020
Nadomešča:
SIST EN ISO 13017:2012
SIST EN ISO 13017:2012/A1:2016
Zobozdravstvo - Magnetni priključki (ISO 13017:2020)
Dentistry - Magnetic attachments (ISO 13017:2020)
Zahnheilkunde - Magnetische Retentionselemente (ISO 13017:2020)
Médecine bucco-dentaire - Attaches magnétiques (ISO 13017:2020)
Ta slovenski standard je istoveten z: EN ISO 13017:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 13017
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2020
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 13017:2012
English Version
Dentistry - Magnetic attachments (ISO 13017:2020)
Médecine bucco-dentaire - Attaches magnétiques (ISO Zahnheilkunde - Magnetische Retentionselemente (ISO
13017:2020) 13017:2020)
This European Standard was approved by CEN on 27 June 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13017:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13017:2020) 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 2021, and conflicting national standards shall
be withdrawn at the latest by January 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13017:2012.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13017:2020 has been approved by CEN as EN ISO 13017:2020 without any modification.

INTERNATIONAL ISO
STANDARD 13017
Second edition
2020-07
Dentistry — Magnetic attachments
Médecine bucco-dentaire — Attaches magnétiques
Reference number
ISO 13017:2020(E)
©
ISO 2020
ISO 13017:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 13017:2020(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Material . 3
4.1.1 Magnet core . 3
4.1.2 Components other than the magnet core . 3
4.1.3 Reported chemical composition . 3
4.2 Hazardous elements . 3
4.2.1 Recognized hazardous elements . 3
4.2.2 Permitted limits for the hazardous elements cadmium, beryllium and lead . 3
4.2.3 Manufacturer’s reported nickel content and permitted deviation . 4
4.3 Risk analysis . 4
4.4 Magnetic flux leakage . 4
4.5 Retentive force. 4
4.6 Corrosion resistance . 4
4.6.1 Released ions . 4
4.6.2 Breakdown potential . 4
5 Preparation of test specimens . 4
5.1 Retentive force. 4
5.2 Static immersion test . 4
5.3 Anodic polarization . 5
6 Test methods . 5
6.1 Information, instructions and marking . 5
6.2 Magnetic flux leakage . 5
6.2.1 Apparatus . 5
6.2.2 Test procedure . 5
6.3 Retentive force. 5
6.3.1 Apparatus . 5
6.3.2 Materials . 6
6.3.3 Fixing procedure . 7
6.3.4 Test procedure . 7
6.3.5 Analysis . 7
6.4 Corrosion resistance . 9
6.4.1 Static immersion test . 9
6.4.2 Anodic polarization .10
7 Information and instructions for use .11
8 Marking and labelling .11
8.1 Marking .11
8.2 Labelling .11
Bibliography .12
ISO 13017:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was d
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