Dentistry - Wires for use in orthodontics (ISO 15841:2014)

ISO 15841:2014 specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components.
ISO 15841:2014 gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labelling information.

Zahnheilkunde - Drähte für die Kieferorthopädie (ISO 15841:2014)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Drähte fest, die in festsitzenden und
herausnehmbaren kieferorthopädischen Apparaturen verwendet werden. Sie enthält vorgeformte kieferorthopädische
Bögen, schließt aber Federn und andere vorgeformte Komponenten aus.
Diese Internationale Norm enthält genaue Anforderungen an die Darstellung der physikalischen und
mechanischen Eigenschaften von kieferorthopädischen Drähten, die Prüfverfahren, mit denen sie bestimmt
werden können, sowie Angaben zur Verpackung und Kennzeichnung.

Médecine bucco-dentaire - Fils pour utilisation en orthodontie (ISO 15841:2014)

L'ISO 15841:2014 spécifie les exigences et les méthodes d'essai relatives aux fils à utiliser pour les appareils orthodontiques fixes et amovibles. Elle s'applique notamment aux fils métalliques orthodontiques pour arc préformés mais exclut les ressorts et autres éléments préformés.
L'ISO 15841:2014 fixe également les exigences détaillées concernant la présentation des caractéristiques physiques et mécaniques des fils orthodontiques, les méthodes d'essai permettant de les déterminer ainsi que des informations portant sur l'emballage et l'étiquetage.

Zobozdravstvo - Žice za uporabo v ortodontiji (ISO 15841:2014)

Standard EN ISO 15841 določa zahteve in preskusne metode za žice, ki se uporabljajo v fiksnih in odstranljivih ortodontskih aparatih. Vključuje vnaprej oblikovane ortodontske usločene žice, vendar ne vključuje vzmeti in drugih vnaprej oblikovanih komponent. Ta mednarodni standard določa podrobne zahteve v zvezi s predstavitvijo fizikalnih in mehanskih lastnosti ortodontskih žic, preskusne metode, s katerimi jih je mogoče določiti, ter informacije o embalaži in označevanju.

General Information

Status
Published
Publication Date
19-Aug-2014
Withdrawal Date
27-Feb-2015
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Aug-2014
Completion Date
20-Aug-2014

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SLOVENSKI STANDARD
01-november-2014
1DGRPHãþD
SIST EN ISO 15841:2006
Zobozdravstvo - Žice za uporabo v ortodontiji (ISO 15841:2014)
Dentistry - Wires for use in orthodontics (ISO 15841:2014)
Zahnheilkunde - Drähte für die Kieferorthopädie (ISO 15841:2014)
Médecine bucco-dentaire - Fils pour utilisation en orthodontie (ISO 15841:2014)
Ta slovenski standard je istoveten z: EN ISO 15841:2014
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15841
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2014
ICS 11.060.10 Supersedes EN ISO 15841:2006
English Version
Dentistry - Wires for use in orthodontics (ISO 15841:2014)
Médecine bucco-dentaire - Fils pour utilisation en Zahnheilkunde - Drähte für die Kieferorthopädie (ISO
orthodontie (ISO 15841:2014) 15841:2014)
This European Standard was approved by CEN on 25 July 2014.

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, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15841:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 15841:2014) 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 February 2015, and conflicting national standards shall be withdrawn
at the latest by February 2015.
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.
This document supersedes EN ISO 15841:2006.
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 15841:2014 has been approved by CEN as EN ISO 15841:2014 without any modification.

INTERNATIONAL ISO
STANDARD 15841
Second edition
2014-08-15
Dentistry — Wires for use in
orthodontics
Médecine bucco-dentaire — Fils pour utilisation en orthodontie
Reference number
ISO 15841:2014(E)
©
ISO 2014
ISO 15841:2014(E)
© ISO 2014
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 15841:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 General . 3
5.2 Dimensions . 3
5.3 Austenite finish temperature . 3
5.4 Mechanical properties . 3
5.5 Hazardous elements . 3
6 Test methods . 3
6.1 Sampling . 3
6.2 Dimensions . 3
6.3 Austenite-finish temperature . 4
6.4 Mechanical tests . 5
7 Packaging and labelling information to be provided to the user .8
7.1 General requirements . 8
7.2 Packaging . 8
7.3 Labelling . 9
Bibliography .10
ISO 15841:2014(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 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 1, Filling and
restorative materials.
This second edition of ISO 15841 cancels and replaces the first edition (ISO 15841:2006), which has
been revised to include a reference to ASTM F2082.
iv © ISO 2014 – All rights reserved

ISO 15841:2014(E)
Introduction
As with the first edition, the second edition of this International Standard has been developed to help
clinicians compare the wires from different manufacturers and suppliers. In particular, it has been
written as a result of the development of new test methods.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this International Standard. For the assessment of possible
biological hazards, reference can be made to ISO 10993 and ISO 7405.
INTERNATIONAL STANDARD ISO 15841:2014(E)
Dentistry — Wires for use in orthodontics
1 Scope
This International Standard specifies requirements and test methods for wires to be used in fixed and
removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs
and other preformed components.
This International Standard gives detailed requirements concerning the presentation of the physical
and mechanical properties of orthodontic wires, the test methods by which they can be determined, and
packaging and labelling information.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 6892-1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ASTM F2082, Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium
Shape Memory Alloys by Bend and Free Recovery
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
austenite-finish temperature
T
af
temperature at which the metallurgical transformation from the low-temperature martensite phase to
the high-temperature austenite phase is completed
3.2
force deflection rate
F
Δ
increment of load to produce a unit increment of deflection in the proportional region, expressed in
N/mm (e.g. u
...

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