EN ISO 15841:2006
(Main)Dentistry - Wires for use in orthodontics (ISO 15841:2006)
Dentistry - Wires for use in orthodontics (ISO 15841:2006)
ISO 15841:2006 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 15841:2006 gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, packaging, and labelling information.
Zahnheilkunde - Drähte für die Kieferorthopädie (ISO 15841:2006)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Drähte fest, die in festsitzenden und herausnehmbaren kieferorthopädischen Apparaturen verwendet werden. Sie enthält vorgefertigte kieferortho¬pädische Bögen, schließt aber Federn und andere vorgefertigte Komponenten aus.
Diese Internationale Norm enthält genaue Anforderungen an die Darstellung der physikalischen und mecha¬nischen Eigenschaften von kieferorthopädischen Drähten, die Prüfverfahren mit denen sie bestimmt werden können, sowie Angaben zur Verpackung und Kennzeichnung.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405 und ISO 10993-1 heranzuziehen.
Art dentaire - Fils pour utilisation en orthodontie (ISO 15841:2006)
L'ISO 15841:2006 spécifie les exigences et les méthodes d'essai relatives aux fils à utiliser sur des 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 15841:2006 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 - Ortodontski materiali - Žice (ISO 15841:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2006
Zobozdravstvo - Ortodontski materiali - Žice (ISO 15841:2006)
Dentistry - Wires for use in orthodontics (ISO 15841:2006)
Zahnheilkunde - Drähte für die Kieferorthopädie (ISO 15841:2006)
Art dentaire - Fils pour utilisation en orthodontie (ISO 15841:2006)
Ta slovenski standard je istoveten z: EN ISO 15841:2006
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
October 2006
ICS 11.060.10
English Version
Dentistry - Wires for use in orthodontics (ISO 15841:2006)
Art dentaire - Fils pour utilisation en orthodontie (ISO Zahnheilkunde - Drähte für die Kieferorthopädie (ISO
15841:2006) 15841:2006)
This European Standard was approved by CEN on 4 September 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15841:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 15841:2006) 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 April 2007, and conflicting national
standards shall be withdrawn at the latest by April 2007.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 15841:2006 has been approved by CEN as EN ISO 15841:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 15841
First edition
2006-10-01
Dentistry — Wires for use in orthodontics
Art dentaire — Fils pour utilisation en orthodontie
Reference number
ISO 15841:2006(E)
©
ISO 2006
ISO 15841:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 2006 – All rights reserved
ISO 15841:2006(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 . 4
7 Packaging and labelling information to be provided to the user . 7
7.1 General requirements. 7
7.2 Packaging . 7
7.3 Labelling . 8
Bibliography . 9
ISO 15841:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15841 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
iv © ISO 2006 – All rights reserved
ISO 15841:2006(E)
Introduction
This first edition of ISO 15841 has been developed as a result of the difficulty often encountered by clinicians
in making meaningful comparisons between wires using the information currently available from
manufacturers and suppliers.
INTERNATIONAL STANDARD ISO 15841:2006(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, packaging,
and labelling information.
Specified qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard but it is recommended that to assess possible biological or toxicological hazards,
reference should be made to ISO 7405 and ISO 10993-1.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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, Metallic materials — Tensile testing at ambient temperature
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
bending stiffness
S
b
increment of load to produce a unit increment of deflection in the proportional region, expressed in N/mm (e.g.
used in the bend test)
3.3
descriptor
code to identify the nominal cross-sectional dimension(s) of a wire in thousandths of an inch without unit
designation, in accordance with accepted orthodontic practice (e.g., 16, 18, 17 × 25, 21 × 21)
ISO 15841:2006(E)
3.4
diagonal
largest cross-sectional dimension of a rectangular wire
See Figure 1.
3.5
multistrand wire
orthodontic wire fabricated from two or more individual strands of wire that may be twisted, braided or made
into a co-axial wire
3.6
offset bending force
F
S(0,1)
force measured at a permanent deflection of 0,1 mm during loading in the bend test
3.7
height
smaller cross-sectional dimension of a rectangular wire
See Figure 1.
3.8
width
larger cross-sectional dimension of a rectangular wire
See Figure 1.
Key
1 diagonal
2 height
3 width
Figure 1 — Dimensions of cross-section of a wire
4 Classification
For the purposes of this document, wires are classified on the basis of their elastic behaviour.
a) Type 1 wires: wires displaying linear elastic behaviour during unloading at temperatures up to 50 °C.
b) Type 2 wires: wires not displaying linear elastic behaviour during unloading at temperatures up to 50 °C.
2 © ISO 2006 – All rights reserved
ISO 15841:2006(E)
5 Requirements
5.1 General
The manufacturer shall declare the following properties, which, when tested in accordance with the test
methods described in Clause 6, shall be within the ranges stated by the manufacturer.
5.2 Dimensions
Each cross-sectional dimension (diameter, width, height and diagonal, as applicable) of the wire shall be
stated to the nearest 0,01 mm. For multistrand wires, the dimensions shall be the internal dimensions of a
tube that would just contain the wire.
5.3 Austenite-finish temperature
For Type 2 wires, the austenite-finish temperature shall be stated to the nearest 1 °C.
5.4 Mechanical properties
5.4.1 Type 1 wires
When a manufacturer states that different segments of an orthodontic wire have different mechanical
properties, the results for each segment shall be tested separately and stated separately.
The elastic modulus, in gigapascals, 0,2 % proof strength, in megapascals, and percentage elongation after
fracture when tested in accordance with 6.4.2, shall be stated.
The bending stiffness, in newtons per millimetre, and 0,1 mm offset bending force, in newtons, when tested in
accordance with 6.4.3 shall be s
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.