EN ISO 19023:2018
(Main)Dentistry - Orthodontic anchor screws (ISO 19023:2018)
Dentistry - Orthodontic anchor screws (ISO 19023:2018)
ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment.
ISO 19023:2018 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.
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 orthodontiques (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
Overview
EN ISO 19023:2018 - Dentistry - Orthodontic anchor screws (ISO 19023:2018) specifies requirements and test methods for orthodontic anchor screws (temporary intraoral skeletal anchorage devices). The standard defines how to compare physical and mechanical properties, and it gives packaging, labelling and information-to-user requirements to support clear communication between manufacturers, clinicians and testing laboratories. Note: these screws are temporary and are removed at the end of orthodontic treatment.
Key Topics and Technical Requirements
- Materials
- Acceptable materials reference ISO 5832‑2, ISO 5832‑3, ASTM F67 or ASTM F136. If other alloys are used, the manufacturer must declare composition components present ≥ 0.1% by mass.
- Hazardous elements
- Cadmium, beryllium, lead and nickel are designated hazardous; manufacturers shall state their concentrations (mass fraction %).
- Dimensions and tolerances
- Important dimensions (thread diameters, shaft length, neck height, head height, overall length) must be declared and measured to an accuracy of 0.05 mm (Clause 6.1).
- Torsional performance
- Fracture torque and insertion torque under worst‑case conditions must be specified. Fracture torque is tested per ASTM F543‑17 (test method A1) with a minimum of five specimens (Clause 6.2). Insertion torque is measured using a synthetic bone analogue (e.g., highest density Sawbones per ASTM F‑1839‑08) to simulate maximum bone density (Clause 6.3).
- Reporting and compliance
- Test results for each specimen must lie within the manufacturer’s declared ranges/tolerances for compliance (Clause 5.6).
- Information to user, labelling and packaging
- Requirements cover instructions for use, labelling content and packaging to ensure safe insertion/removal and identification (Clause 7).
Applications and Who Uses This Standard
- Manufacturers - to design, test and declare material, dimensional and mechanical properties of orthodontic anchor screws for market access and product data sheets.
- Clinical users (orthodontists, oral surgeons) - to compare products using standardized metrics (insertion torque, fracture torque, dimensions) for treatment planning and device selection.
- Testing laboratories and conformity assessors - to perform dimensional and torsional tests in a standardized manner.
- Regulators and procurement teams - to specify requirements in tenders, certificates and technical files.
Related Standards
- ISO 5832‑2, ISO 5832‑3 (implant materials)
- ASTM F67, ASTM F136 (titanium specifications)
- ASTM F543‑17 (bone screw test methods)
- ASTM F‑1839‑08 (synthetic bone)
- ISO 10993‑1, ISO 7405 (biological/toxicological assessment - recommended references)
Keywords: EN ISO 19023:2018, orthodontic anchor screws, temporary skeletal anchorage, torsional performance, insertion torque, fracture torque, dental materials, packaging and labelling.
Standards Content (Sample)
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.
ISO copyright office
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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
...
Frequently Asked Questions
EN ISO 19023:2018 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Orthodontic anchor screws (ISO 19023:2018)". This standard covers: ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. ISO 19023:2018 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.
ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. ISO 19023:2018 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.
EN ISO 19023:2018 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials; 11.060.15 - Dental implants. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 19023:2018 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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