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 Retentionselemente (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
Public Enquiry End Date
19-Mar-2018
Publication Date
10-Sep-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-Aug-2020
Due Date
30-Oct-2020
Completion Date
11-Sep-2020

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SLOVENSKI STANDARD
SIST EN ISO 13017:2020
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
SIST EN ISO 13017:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13017:2020
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SIST EN ISO 13017:2020
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.
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SIST EN ISO 13017:2020
EN ISO 13017:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 13017:2020
EN ISO 13017:2020 (E)
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.

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SIST EN ISO 13017:2020
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SIST EN ISO 13017:2020
INTERNATIONAL ISO
STANDARD 13017
Second edition
2020-07
Dentistry — Magnetic attachments
Médecine bucco-dentaire — Attaches magnétiques
Reference number
ISO 13017:2020(E)
ISO 2020
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SIST EN ISO 13017:2020
ISO 13017:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 13017:2020
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 2020 – All rights reserved iii
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SIST EN ISO 13017:2020
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 drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,

Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 13017:2012),

which has been technically revised. It also incorporates the Amendment ISO 13017:2012/Amd.1:2015.

The main changes compared to the previous edition are as follows:
— addition of ISO 14233 to Clause 2;
— addition of lead as a hazardous element;

— addition of the cleaning method of test specimens prepared for retentive force;

— change of the device for retentive force to a single shaft type;
— change of Figure 3 to the single shaft type device;

— specification of the performance of the device with respect to moving friction force and modification

of specimen tables;
−1 −1

— change of a cross-head speed in measuring retentive force from 5,0 mm min to 2,0 mm min ;

— addition of materials for fixing a specimen on the table such as cyanoacrylate adhesive and self-

curing acrylic resin;

— deletion of the description of the adhesive double sided tape to fix a specimen on the table;

— specification of the procedures to fix a specimen on the table;
— addition of detailed method of measuring retentive force;
— addition of explaining the calculation method of retentive force;
— addition of a figure that shows a retentive force curve as Figure 4;
iv © ISO 2020 – All rights reserved
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SIST EN ISO 13017:2020
ISO 13017:2020(E)

— specification of quantitative analyses in the static immersion test using definition of determination

limit and detection limit;
— addition of “quantity” to labelling.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 13017:2020
ISO 13017:2020(E)
Introduction

The early practical uses of permanent magnets were as navigational compasses. Magnets have since

become firmly integrated into today’s modern electronic device technology. The development of

magnetic technology has generated rare earth magnets. Their excellent magnetic character properties

permit predictable clinical applications and use. Dental magnetic attachments are one of the products

composed of rare earth magnets, providing retention, support and stabilization of dental and

maxillofacial appliances.

Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable

biological hazard are not included in this document, but for the assessment of possible biological or

toxicological hazards, reference can be made to ISO 10993-1 and ISO 7405.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 13017:2020
INTERNATIONAL STANDARD ISO 13017:2020(E)
Dentistry — Magnetic attachments
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary
ISO 3585, Borosilicate glass 3.3 — Properties

ISO 5832-1, Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

ISO 10271, Dentistry — Corrosion test methods for metallic materials
ISO 14233, Dentistry — Polymer-based die materials

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances

IEC 60404-8-1, Magnetic materials — Part 8-1: Specifications for individual materials — Magnetically

hard materials
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 10271 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
magnetic attachment
device to provide retention of a prosthesis mainly utilizing magnetic attraction
3.1.1
open magnetic circuit attachment

magnetic attachment (3.1) wherein a magnetized permanent magnet is working by itself with no high

permeability material

Note 1 to entry: The magnet is encased within a corrosion-resistant metal or alloy cover of titanium, titanium

...

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