SIST EN ISO 19023:2018

Dentistry - Orthodontic anchor screws (ISO 19023:2018)

This International Standard specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment, in combination with orthodontic appliances.
It specifies dimensions, shapes, materials and the marking.
This International Standard does not cover palatal implants used in orthodontics which are intended to osseointegrate.

Zahnheilkunde - Kieferorthopädische Ankerschrauben (ISO 19023:2018)

Dieses Dokument legt Anforderungen und Prüfverfahren für kieferorthopädische Ankerschrauben fest, die in der kieferorthopädischen Behandlung zusammen mit kieferorthopädischen Apparaturen verwendet werden. Kieferorthopädische Ankerschrauben werden zur temporären skelettalen Verankerung während einer kieferorthopädischen Behandlung verwendet und nach Abschluss der Behandlung wieder entfernt. Ähnlich wie enossale Dentalimplantate werden sie deshalb in maxillo-faziale Knochenstrukturen inseriert.
Dieses Dokument enthält Einzelheiten über Verfahren zum Vergleich der physikalischen und mechanischen Eigenschaften von kieferorthopädischen Ankerschrauben, zusammen mit Prüfverfahren sowie Angaben zur Verpackung und Kennzeichnung.

Médecine bucco-dentaire - Vis d'ancrage orthodontique (ISO 19023:2018)

ISO 19023:2018 spécifie des exigences et des méthodes d'essai pour les vis d'ancrage orthodontiques utilisées dans le cadre d'un traitement orthodontique.
ISO 19023:2018 fournit des méthodes détaillées pour comparer les propriétés physiques et mécaniques des vis d'ancrage orthodontiques, ainsi que des méthodes d'essai et des informations relatives à l'emballage et à l'étiquetage.
NOTE       Les vis d'ancrage orthodontiques sont utilisées pour fournir un ancrage squelettique intra-oral temporaire pendant un traitement orthodontique et sont retirées à la fin de celui-ci. Similaires aux implants dentaires endo-osseux, elles sont de fait insérées dans les structures osseuses maxillo-faciales.

Zobozdravstvo - Ortodontski sidrni vijaki (ISO 19023:2018)

Ta mednarodni standard določa zahteve in preskusne metode za ortodontske sidrne vijake, uporabljene pri ortodontskem zdravljenju, v kombinaciji z ortodontskimi pripomočki. Določa dimenzije, oblike, materiale in oznako. Ta mednarodni standard ne obsega nebnih vsadkov, uporabljenih v ortodontiji, ki so predvideni za oseointegracijo.

General Information

• Status: Published
• Public Enquiry End Date: 19-May-2017
• Publication Date: 16-Apr-2018
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Mar-2018
• Due Date: 14-May-2018
• Completion Date: 17-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 19023:2018 - Dentistry - Orthodontic anchor screws (ISO 19023:2018)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 19023:2018
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
SIST EN ISO 19023:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 19023:2018

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

SIST EN ISO 19023:2018


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.

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

SIST EN ISO 19023:2018
EN ISO 19023:2018 (E)
Contents Page
European foreword . 3

2

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

SIST EN ISO 19023:2018
EN ISO 19023:2018 (E)
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.


3

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

SIST EN ISO 19023:2018

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

SIST EN ISO 19023:2018
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

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

SIST EN ISO 19023:2018
ISO 19023:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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

SIST EN ISO 19023:2018
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 2018 – All rights reserved iii

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

SIST EN ISO 19023:2018
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
...