Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2022)

This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

Zahnheilkunde - Elastomeres Zubehör für die Kieferorthopädie (ISO 21606:2022)

Dieses Dokument legt die Anforderungen und ihre Prüfverfahren für alle elastomeren Hilfsmittel fest, die in der Kieferorthopädie sowohl innerhalb als auch außerhalb des Munds in Verbindung mit festsitzenden und herausnehmbaren Apparaturen verwendet werden.

Médecine bucco-dentaire - Auxiliaires élastomériques utilisés en orthodontie (ISO 21606:2022)

Le présent document spécifie les exigences et méthodes d’essai applicables à tous les auxiliaires élastomériques 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 21606:2022)

Ta dokument določa zahteve in povezane preskusne metode, ki se uporabljajo za vse elastomerne pripomočke za uporabo v ortodontiji znotraj in zunaj ustne votline, v povezavi s fiksnimi in odstranljivimi ortodontskimi aparati.

General Information

Status
Published
Publication Date
30-Aug-2022
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Aug-2022
Completion Date
31-Aug-2022

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SLOVENSKI STANDARD
SIST EN ISO 21606:2022
01-november-2022
Nadomešča:
SIST EN ISO 21606:2008
Zobozdravstvo - Elastomerni pripomočki za uporabo v ortodontiji (ISO 21606:2022)
Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2022)
Zahnheilkunde - Elastomeres Zubehör für die Kieferorthopädie (ISO 21606:2022)
Médecine bucco-dentaire - Auxiliaires élastomériques utilisés en orthodontie (ISO
21606:2022)
Ta slovenski standard je istoveten z: EN ISO 21606:2022
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 21606:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21606:2022

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SIST EN ISO 21606:2022


EN ISO 21606
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2022
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 21606:2007
English Version

Dentistry - Elastomeric auxiliaries for use in orthodontics
(ISO 21606:2022)
Médecine bucco-dentaire - Auxiliaires élastomériques Zahnheilkunde - Elastomeres Zubehör für die
utilisés en orthodontie (ISO 21606:2022) Kieferorthopädie (ISO 21606:2022)
This European Standard was approved by CEN on 30 July 2022.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21606:2022 E
worldwide for CEN national Members.

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SIST EN ISO 21606:2022
EN ISO 21606:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 21606:2022
EN ISO 21606:2022 (E)
European foreword
This document (EN ISO 21606:2022) 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 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
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.
This document supersedes EN ISO 21606:2007
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21606:2022 has been approved by CEN as EN ISO 21606:2022 without any modification.

3

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SIST EN ISO 21606:2022

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SIST EN ISO 21606:2022
INTERNATIONAL ISO
STANDARD 21606
Second edition
2022-08
Dentistry — Elastomeric auxiliaries
for use in orthodontics
Médecine bucco-dentaire — Auxiliaires élastomériques utilisés en
orthodontie
Reference number
ISO 21606:2022(E)
© ISO 2022

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SIST EN ISO 21606:2022
ISO 21606:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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SIST EN ISO 21606:2022
ISO 21606:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
4 R e qu i r ement s . 3
4.1 General . 3
4.2 Dimensions . 3
4.3 M echanical properties . 3
4.3.1 Initial extension force . 3
4.3.2 2 4 h residual force. 3
4.3.3 Ultimate extension . 3
5 Te s t me t ho d s . 4
5.1 S ampling . 4
5 . 2 A mbient c ond it ion s. 4
5 . 3 D i men s ion s . 4
5.3.1 Apparatus . 4
5.3.2 Procedure . 4
5.4 I nitial extension force, F . 4
0
5.4.1 A pparatus . 4
5.4.2 Procedure . 5
5.5 2 4 h residual force, F . 5
24
5.5.1 Ap paratus . 5
5.5.2 P rocedure . 6
5.6 U ltimate extension, A . 6
5.6.1 Apparatus . 6
5.6.2 Procedure . 7
5.7 T reatment of results . 7
6 Marking, labelling and packaging .7
6.1 General requirements . 7
6.2 P ackaging and labelling . 7
Bibliography . 8
iii
© ISO 2022 – All rights reserved

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SIST EN ISO 21606:2022
ISO 21606:2022(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
...

SLOVENSKI STANDARD
oSIST prEN ISO 21606:2022
01-januar-2022
Zobozdravstvo - Elastomerni pripomočki za uporabo v ortodontiji (ISO/DIS
21606:2021)
Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO/DIS 21606:2021)
Zahnheilkunde - Elastomeres Zubehör für die Kieferorthopädie (ISO/DIS 21606:2021)
Médecine bucco-dentaire - Auxiliaires élastomériques utilisés en orthodontie (ISO/DIS
21606:2021)
Ta slovenski standard je istoveten z: prEN ISO 21606
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 21606:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 21606:2022

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oSIST prEN ISO 21606:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21606
ISO/TC 106/SC 1 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2021-11-17 2022-02-09
Dentistry — Elastomeric auxiliaries for use in orthodontics
Art dentaire — Auxiliaires élastomères utilisés en orthodontie
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 21606:2021(E)
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. © ISO 2021

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oSIST prEN ISO 21606:2022
ISO/DIS 21606:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2021 – All rights reserved

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oSIST prEN ISO 21606:2022
ISO/DIS 21606:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Dimensions . 3
4.3 Mechanical properties . 3
4.3.1 Initial extension force . 3
4.3.2 24 hour residual force . . 3
4.3.3 Ultimate extension . 3
5 Test methods . 4
5.1 Sampling . 4
5.2 Ambient conditions. 4
5.3 Dimensions . 4
5.3.1 Apparatus . 4
5.3.2 Procedure . 4
5.4 Initial extension force, F . 4
0
5.4.1 Apparatus . 4
5.4.2 Procedure . 5
5.5 24 hour residual force, F . 5
24
5.5.1 Apparatus . 5
5.5.2 Procedure . 6
5.6 Ultimate extension, A . 6
5.6.1 Apparatus . 6
5.6.2 Procedure . 7
5.7 Treatment of Results . 7
6 Marking, labelling and packaging .7
6.1 General requirements . 7
6.2 Packaging and labelling . 7
Bibliography . 8
iii
© ISO 2021 – All rights reserved

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oSIST prEN ISO 21606:2022
ISO/DIS 21606:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document 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 (ISO #####:####), which
has been technically revised.
The main changes compared to the previous edition are as follows:
— xxx xxxxxxx xxx xxxx
A list of all parts in the ISO ##### series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
  © ISO 2021 – All rights reserved

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oSIST prEN ISO 21606:2022
ISO/DIS 21606:2021(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 auxiliaries using the information
currently available from manufacturers and suppliers.
Specific qualitative and quantitative requirements for freed
...

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