SIST EN ISO 15841:2014
(Main)Dentistry - Wires for use in orthodontics (ISO 15841:2014)
Dentistry - Wires for use in orthodontics (ISO 15841:2014)
EN ISO 15841 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.
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 vorgefertigte kiefer-orthopädische Bögen, schließt aber Federn und andere vorgefertigte 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.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer oder toxikologischer Risiken wird empfohlen, ISO 7405 und ISO 10993 1 heranzuziehen.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15841:2014
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
SIST EN ISO 15841:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 15841:2014
---------------------- Page: 2 ----------------------
SIST EN ISO 15841:2014
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 15841:2014
EN ISO 15841:2014 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 15841:2014
EN ISO 15841:2014 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 15841:2014
---------------------- Page: 6 ----------------------
SIST EN ISO 15841:2014
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
---------------------- Page: 7 ----------------------
SIST EN ISO 15841:2014
ISO 15841:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST EN ISO 15841:2014
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 2014 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 15841:2014
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
---------------------- Page: 10 ----------------------
SIST EN ISO 15841:2014
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.
© ISO 2014 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 15841:2014
---------------------- Pag
...
SLOVENSKI STANDARD
oSIST prEN ISO 15841:2013
01-oktober-2013
Zobozdravstvo - Žice za uporabo v ortodontiji (ISO/DIS 15841:2013)
Dentistry - Wires for use in orthodontics (ISO/DIS 15841:2013)
Zahnheilkunde - Drähte für die Kieferorthopädie (ISO/DIS 15841:2013)
Médecine bucco-dentaire - Fils pour utilisation en orthodontie (ISO/DIS 15841:2013)
Ta slovenski standard je istoveten z: prEN ISO 15841 rev
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
oSIST prEN ISO 15841:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 15841:2013
---------------------- Page: 2 ----------------------
oSIST prEN ISO 15841:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 15841
ISO/TC 106/SC 1 Secretariat: AFNOR
Voting begins on Voting terminates on
2013-05-16 2013-10-16
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ ORGANISATION INTERNATIONALE DE NORMALISATION
Dentistry — Wires for use in orthodontics
Médecine bucco-dentaire — Fils pour utilisation en orthodontie
[Revision of first edition (ISO 15841:2006)]
ICS 11.060.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2013
---------------------- Page: 3 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
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 2013 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 3
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 . 4
6.1 Sampling . 4
6.2 Dimensions . 4
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 . 9
7.3 Labelling . 9
Bibliography . 10
© ISO 2013 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
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.
This second/third/. edition cancels and replaces the first/second/. edition (), [clause(s) / subclause(s) /
table(s) / figure(s) / annex(es)] of which [has / have] been technically revised.
Part [n]:
Part [n+1]:
iv © ISO 2013 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
Introduction
This second edition of ISO 15841 has been developed as a result of the difficulty often encountered by
clinicians when comparing wires using the information currently available from manufacturers and
suppliers.
© ISO 2013 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 15841:2013
---------------------- Page: 8 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
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.
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 – 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
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.used in the bend test)
3.3
descriptor
code to identify the nominal dimension(s) in thousandths of an inch without unit desig-nation, in accordance
with accepted orthodontic practice
© ISO 2013 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 15841:2013
ISO/DIS 15841
3.4
diagonal
largest cross-sectional dimension
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.