SIST 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 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
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Aug-2020
• Due Date: 30-Oct-2020
• Completion Date: 11-Sep-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 13017:2020 - Dentistry - Magnetic attachments (ISO 13017:2020)

Relations

• Replaces: SIST EN ISO 13017:2012 - Dentistry - Magnetic attachments (ISO 13017:2012)
• Effective Date: 01-Oct-2020
• Replaces: SIST EN ISO 13017:2012/A1:2016 - Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)
• Effective Date: 01-Oct-2020

Overview

EN ISO 13017:2020 - Dentistry: Magnetic attachments (ISO 13017:2020) specifies requirements and test methods for evaluating dental magnetic attachments used to provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), implant superstructures, and orthodontic or maxillofacial prostheses including obturators. This European adoption of ISO 13017 (published July 2020) supersedes the 2012 edition and aligns manufacturer, laboratory and regulatory expectations for performance, safety and labelling of magnetic retention elements.

Key topics and requirements

• Scope and definitions: Terminology and intended uses for magnetic attachments in dentistry.
• Materials and composition: Requirements for magnet cores and non‑core components; manufacturers must report chemical composition including nickel content and permitted deviations.
• Hazardous elements: Identification of recognized hazardous elements and inclusion of cadmium, beryllium and lead limits (lead added in this edition).
• Magnetic performance: Tests for retentive force, device performance (single‑shaft retentive-force tester), measurement procedures and analysis - including specimen cleaning and fixation methods (e.g., cyanoacrylate adhesive, self‑curing acrylic resin) and a specified cross‑head speed for measurements.
• Magnetic flux leakage: Apparatus and procedure to assess stray magnetic fields.
• Corrosion resistance: Static immersion tests with quantitative analysis (limits of detection) and anodic polarization procedures to evaluate ion release and breakdown potential.
• Risk analysis, marking and labelling: Requirements for instructions for use, labelling (including quantity), and traceability information.
• References for biological assessment: For biocompatibility/toxicology, the standard refers users to ISO 10993‑1 and ISO 7405.

Practical applications

• Ensures consistent, reproducible evaluation of magnetic attachments used in:
  • Overdentures and partial dentures
  • Implant superstructures and crowns/bridges with magnetic retention
  • Orthodontic and maxillofacial prostheses (obturators)
• Supports product development, quality control, and regulatory compliance by defining test methods for retentive force, corrosion resistance, and magnetic safety.

Who should use this standard

• Dental device manufacturers and R&D teams
• Dental laboratories and prosthodontic technicians
• Test laboratories performing materials and performance testing
• Regulatory bodies, procurement specialists and clinicians assessing device suitability

Related standards

• ISO 10993‑1 (biocompatibility assessment)
• ISO 7405 (dental implants - biologic evaluation)
• ISO 10271 (corrosion test methods)
• ISO 5832‑1, ISO 14233, ISO 15223‑1, ISO 1942, ISO 3585

Using EN ISO 13017:2020 helps ensure magnetic dental attachments meet recognized performance and safety expectations for clinical use.

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 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

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 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

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
...