SIST EN ISO 21606:2008

Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)

This International Standard is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

Zahnheilkunde - Elastomere Elemente für die Kieferorthopädie (ISO 21606:2007)

Diese Internationale Norm gilt für alle elastomeren Elemente die in der Kieferorthopädie verwendet werden wie kieferorthopädische Ringe, elastomere Bänder, elastomere Ketten, Glieder, Fäden und Ligaturen sowohl für intra- und extraorale Anwendungen zusammen mit festsitzenden oder herausnehmbaren Apparaturen.

Art dentaire - Auxiliaires élastomeres utilisés en orthodontie (ISO 21606:2007)

L'ISO 21606:2007 s'applique à tous les auxiliaires élastomères, y compris les élastiques orthodontiques, les anneaux élastomères, les chaînettes, les fils et les ligatures utilisés en orthodontie, à l'intérieur et à l'extérieur de la bouche, en association avec des appareillages fixes et amovibles.

Zobozdravstvo - Elastomerni pripomočki za uporabo v ortodontiji (ISO 21606:2007)

General Information

• Status: Withdrawn
• Publication Date: 18-Feb-2008
• Withdrawal Date: 09-Oct-2022
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 04-Oct-2022
• Due Date: 27-Oct-2022
• Completion Date: 10-Oct-2022
• Ref Project: EN ISO 21606:2007 - Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)

Relations

• Replaced By: SIST EN ISO 21606:2022 - Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2022)
• Effective Date: 01-Nov-2022
• Amended By: SIST EN ISO 21606:2008/oprA1:2020 - Dentistry - Elastomeric auxiliaries for use in orthodontics - Amendment 1 (ISO 21606:2007/DAM 1:2020)
• Effective Date: 01-Jul-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21606:2008
01-april-2008
=RER]GUDYVWYR(ODVWRPHUQLSULSRPRþNL]DXSRUDERYRUWRGRQWLML,62
Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)
Zahnheilkunde - Elastomere Elemente für die Kieferorthopädie (ISO 21606:2007)
Art dentaire - Auxiliaires élastomeres utilisés en orthodontie (ISO 21606:2007)
Ta slovenski standard je istoveten z: EN ISO 21606:2007
ICS:
11.060.10
SIST EN ISO 21606:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 21606
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2007
ICS 11.060.10

English Version
Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO
21606:2007)
Art dentaire - Auxiliaires élastomères utilisés en orthodontie Zahnheilkunde - Elastomere Elemente für die
(ISO 21606:2007) Kieferorthopädie (ISO 21606:2007)
This European Standard was approved by CEN on 31 May 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21606:2007: E
worldwide for CEN national Members.

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EN ISO 21606:2007 (E)





Foreword


This document (EN ISO 21606:2007) 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 December 2007, and conflicting national
standards shall be withdrawn at the latest by December 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,
Bulgaria, 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 21606:2007 has been approved by CEN as EN ISO 21606:2007 without any
modifications.

2

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INTERNATIONAL ISO
STANDARD 21606
First edition
2007-06-01


Dentistry — Elastomeric auxiliaries for
use in orthodontics
Art dentaire — Auxiliaires élastomères utilisés en orthodontie




Reference number
ISO 21606:2007(E)
©
ISO 2007

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ISO 21606:2007(E)
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ii © ISO 2007 – All rights reserved

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ISO 21606:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Requirements . 3
4.1 General. 3
4.2 Dimensions. 3
4.3 Mechanical properties. 3
5 Sampling. 4
6 Test methods. 4
6.1 Ambient conditions . 4
6.2 Dimensions. 4
6.3 Initial extension force, F . 4
0
6.4 24 hour residual force, F . 5
24
6.5 Ultimate extension, A. 7
7 Marking, labelling and packaging . 7
7.1 General requirements. 7
7.2 Packaging and labelling. 7
Bibliography . 8

© ISO 2007 – All rights reserved iii

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ISO 21606:2007(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 21606 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.

iv © ISO 2007 – All rights reserved

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ISO 21606:2007(E)
Introduction
This first edition of ISO 21606 has been developed as a result of the difficulty often encountered by clinicians
in making meaningful comparisons between elastomeric auxillaries using the information currently available
from manufacturers and suppliers.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard, but it is recommended that in assessing possible biological hazards reference should
be made to ISO 10993-1 and ISO 7405.

© ISO 2007 – All rights reserved v

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INTERNATIONAL STANDARD ISO 21606:2007(E)

Dentistry — Elastomeric auxiliaries for use in orthodontics
1 Scope
This International Standard is applicable to all elastomeric auxiliaries including orthodontic elastics,
elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth,
in conjunction with fixed and removable ap
...