SIST EN ISO 13017:2012/A1:2016

Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)

2013-09-19 EMA: Draft for //ENQ received in ISO/CS (see notification of 2013-09-18 in dataservice).

Zahnheilkunde - Magnetische Retentionselemente - Änderung 1 (ISO 13017:2012/Amd 1:2015)

Médecine bucco-dentaire - Attaches magnétiques - Amendement 1 (ISO 13017:2012/Amd 1:2015)

Zobozdravstvo - Magnetni priključki - Dopolnilo A1 (ISO 13017:2012/Amd 1:2015)

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Mar-2014
• Publication Date: 10-Jan-2016
• Withdrawal Date: 09-Sep-2020
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 10-Sep-2020
• Due Date: 03-Oct-2020
• Completion Date: 10-Sep-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 13017:2012/A1:2015 - Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)

Relations

• Amends: SIST EN ISO 13017:2012 - Dentistry - Magnetic attachments (ISO 13017:2012)
• Effective Date: 01-Feb-2016
• Replaced By: SIST EN ISO 13017:2020 - Dentistry - Magnetic attachments (ISO 13017:2020)
• Effective Date: 01-Oct-2020
• Amends: SIST EN ISO 13017:2012 - Dentistry - Magnetic attachments (ISO 13017:2012)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13017:2012/A1:2016
01-februar-2016
=RER]GUDYVWYR0DJQHWQLSULNOMXþNL'RSROQLOR$,62$PG
Dentistry - Magnetic attachments - Amendment 1 (ISO 13017:2012/Amd 1:2015)
Zahnheilkunde - Magnetische Retentionselemente - Änderung 1 (ISO 13017:2012/Amd
1:2015)
Médecine bucco-dentaire - Attaches magnétiques - Amendement 1 (ISO
13017:2012/Amd 1:2015)
Ta slovenski standard je istoveten z: EN ISO 13017:2012/A1:2015
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 13017:2012/A1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 13017:2012/A1:2016

---------------------- Page: 2 ----------------------

SIST EN ISO 13017:2012/A1:2016


EN ISO 13017:2012/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2015
EUROPÄISCHE NORM
ICS 11.060.10
English Version

Dentistry - Magnetic attachments - Amendment 1 (ISO
13017:2012/Amd 1:2015)
Médecine bucco-dentaire - Attaches magnétiques - Zahnheilkunde - Magnetische Retentionselemente -
Amendement 1 (ISO 13017:2012/Amd 1:2015) Änderung 1 (ISO 13017:2012/Amd 1:2015)
This amendment A1 modifies the European Standard EN ISO 13017:2012; it was approved by CEN on 3 October 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13017:2012/A1:2015 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 13017:2012/A1:2016
EN ISO 13017:2012/A1:2015 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 13017:2012/A1:2016
EN ISO 13017:2012/A1:2015 (E)
European foreword
This document (EN ISO 13017:2012/A1:2015) 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 Amendment to the European Standard EN ISO 13017:2012 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and
conflicting national standards shall be withdrawn at the latest by June 2016.
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/Amd 1:2015 has been approved by CEN as EN ISO 13017:2012/A1:2015
without any modification.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 13017:2012/A1:2016

---------------------- Page: 6 ----------------------

SIST EN ISO 13017:2012/A1:2016
INTERNATIONAL ISO
STANDARD 13017
First edition
2012-07-15
AMENDMENT 1
2015-11-15
Dentistry — Magnetic attachments
AMENDMENT 1
Médecine bucco-dentaire — Attaches magnétiques
AMENDEMENT 1
Reference number
ISO 13017:2012/Amd.1:2015(E)
©
ISO 2015

---------------------- Page: 7 ----------------------

SIST EN ISO 13017:2012/A1:2016
ISO 13017:2012/Amd.1:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 13017:2012/A1:2016
ISO 13017:2012/Amd.1:2015(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
© ISO 2015 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 13017:2012/A1:2016

---------------------- Page: 10 ----------------------

SIST EN ISO 13017:2012/A1:2016
ISO 13017:2012/Amd.1:2015(E)
Dentistry — Magnetic attachments
AMENDMENT 1
Page 1, Clause 2
Add the following reference:
“ISO 14233, Dentistry — Polymer-based die materials”

Page 1, Clause 3
Replace the definition of 3.1 with the following:
“device to provide retention of a prosthesis utilizing magnetic attraction”
Replace the definition of 3.1.1 with the following:
“magnetic attachment which utilizes an open magnetic circuit between the coupled device
components”
Replace the NOTE of 3.1.1 with the following:
“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. The attachment uses either a magnet and a
ferromagnetic alloy keeper or two magnets as retentive coupling components.”

Page 2, Clause 3
Replace the definition of 3.2 with the
...