EN ISO 19023:2018

SLOVENSKI STANDARD
01-maj-2018
Zobozdravstvo - Ortodontski sidrni vijaki (ISO 19023:2018)
Dentistry - Orthodontic anchor screws (ISO 19023:2018)
Zahnheilkunde - Kieferorthopädische Ankerschrauben (ISO 19023:2018)
Médecine bucco-dentaire - Vis d'ancrage orthodontique (ISO 19023:2018)
Ta slovenski standard je istoveten z: EN ISO 19023:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19023
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2018
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Orthodontic anchor screws (ISO 19023:2018)
Médecine bucco-dentaire - Vis d'ancrage Zahnheilkunde - Kieferorthopädische Ankerschrauben
orthodontiques (ISO 19023:2018) (ISO 19023:2018)
This European Standard was approved by CEN on 2 February 2018.

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, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19023:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19023:2018) 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 August 2018, and conflicting national standards shall
be withdrawn at the latest by August 2018.
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.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 19023:2018 has been approved by CEN as EN ISO 19023:2018 without any modification.

INTERNATIONAL ISO
STANDARD 19023
First edition
2018-02
Dentistry — Orthodontic anchor
screws
Médecine bucco-dentaire — Vis d'ancrage orthodontiques
Reference number
ISO 19023:2018(E)
©
ISO 2018
ISO 19023:2018(E)
© ISO 2018
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.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 19023:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 2
5 Requirements . 2
5.1 General . 2
5.2 Materials . 3
5.3 Hazardous elements . 3
5.4 Dimensions . 3
5.5 Torsional performance . 3
5.6 Reporting of results . 3
6 Test methods . 3
6.1 Dimensions . 3
6.2 Torsional performance – fracture torque. 3
6.3 Torsional performance – insertion torque . 3
7 Information to be provided to the user . 4
7.1 General requirements . 4
7.2 Instructions for use . 4
7.3 Labelling . 5
7.4 Packaging . 5
Bibliography . 6
ISO 19023:2018(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and restorative materials.
iv © ISO 2018 – All rights reserved

ISO 19023:2018(E)
Introduction
Orthodontic anchor screws for temporary skeletal anchorage of orthodontic appliances are considered
as auxiliary orthodontic devices.
Orthodontic anchor screws are medical devices used in dentistry. Unlike implants, such as endosseous
dental implants, which are intended to remain permanently inside the bone and where, therefore,
osseointegration is desired, orthodontic anchor screws are removed at the end of the orthodontic
treatment. Insertion and removal of orthodontic anchor screws require the appropriate instruments
and adapters.
This document has been developed as a result of the difficulty often encountered by clinicians to make
meaningful comparisons between orthodontic anchor screws using the information currently available
from manufacturers and suppliers.
Thus the purpose of this document is to facilitate communication between manufacturers and clinicians
which will allow comparison between various orthodontic anchor screws.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazard are not included in this document, but it is recommended that, for the assessment of
possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 19023:2018(E)
Dentistry — Orthodontic anchor screws
1 Scope
This document specifies requirements and test methods for orthodontic anchor screws used in
orthodontic treatment.
This document gives details of methods to compare physical and mechanical properties of orthodontic
anchor screws together with test methods and packaging and labelling information.
NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during
orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental
implants, they are, therefore inserted into the maxillo-facial bone structures.
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 editio
...