SIST EN ISO 13017:2012
(Main)Dentistry - Magnetic attachments (ISO 13017:2012)
Dentistry - Magnetic attachments (ISO 13017:2012)
This International Standard 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. This International Standard does not specify qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risk, which can be assessed using ISO 10993-1 and ISO 7405.
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 dentaires 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
Relations
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
2
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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.
3
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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 the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 13017:2012
ISO 13017:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 13017 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
© ISO 2012 – All rights reserved iii
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SIST EN ISO 13017:2012
ISO 13017:2012(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.
iv © ISO 2012 – All rights reserved
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SIST EN ISO 13017:2012
INTERNATIONAL STANDARD ISO 13017:2012(E)
Dentistry — Magnetic attachments
1 Scope
This International Standard 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.
This International Standard does not specify qualitative and quantitative test methods for demonstrating
freedom from unacceptable biological risk, which can be assessed using ISO 10993-1 and ISO 7405.
2 Normative references
The following referenced documents are indispensable for the application 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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part1: General requirements
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
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 and the following apply.
3.1
magnetic attachment
device to provide retention of a prosthesis utilizing magnetic attraction as shown in Figures 1 and 2
3.1.1
open magnetic circuit attachment
magnetic attachment which utilizes an open magnetic circuit between coupled components
NOTE The magnet is encased within a corrosion-resistant metal or alloy cover of titanium, titanium alloy or stainless
steel to prevent corrosion of the magnet, and utilizes the attractive force between either two magnets or between a magnet
and a ferromagnetic alloy keeper as retentive coupling components.
See Figure 1.
© ISO 2012 – All rights reserved 1
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SIST EN ISO 13017:2012
ISO 13017:2012(E)
a) Combination of a magnet and a keeper b) Combination of two magnets
Key
1 magnet
2 keeper
3 magnet core
4 cover
Figure 1 — Schematic diagrams of open magnetic circuit attachment
3.1.2
closed magnetic circuit attachment
magnetic attachment which utilizes a closed magnetic circuit between the coupled device components
NOTE The attachment consists of a combination of a magnetic assembly and a keeper. Examples are sandwich type
and cup-yoke type.
See Figure 2.
a) Sandwich type b) Cup-yoke type
Key
1 magnetic assembly
2 keeper
3 yoke
4 magnet core
5 spacer
6 cover
Figure 2 ― Schematic diagrams of closed magnetic circuit attachment
3.2
magnetic assembly
assembly composed of a small magnet which is sealed within ferromagnetic yokes and non-magnetic spacers,
completing closed magnetic circuits
NOTE The closed magnetic circuit is a complete circulating path for magnetic flux through the yoke and keeper, which
are made of ferromagnetic materials. This circuit can enhance the retentive force and reduce the magnetic flux leakage.
2 © ISO 2012 – All rights reserved
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SIST EN ISO 13017:2012
ISO 13017:2012(E)
3.3
keeper
ferromagnetic alloy component used to retain a prosthesis
NOTE The keeper is placed across the poles of a magnet or a magnetic assembly to complete the magnetic circuit
and fixed to an abutment to retain a prosthesis.
3.4
yoke
ferromagnetic alloy component connected to a permanent magnet used for concentrating magnetic flux
4 Requirements
4.1 Material
4.1.1 Magnet core
A magnet that is classified by principal constituents in accordance with IEC 60404-8-1 shall be used as
the magnet core.
4.1.2 Components other than the magnet core
A material whose chemical composition is declared by the manufacturer shall be used for components of the
dental magnetic attachment, other than the magnet core.
4.1.3 Reported chemical composition
For the magnet core, the principal constitue
...
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