Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information.
This document is applicable to brackets and tubes for use in fixed orthodontic appliances.
This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

Zahnheilkunde - Brackets und Röhrchen für die Kieferorthopädie (ISO 27020:2019)

Dieses Dokument legt Anforderungen und Prüfverfahren fest für den Vergleich der funktionalen Abmessungen von kieferorthopädischen Brackets und Röhrchen und ihre chemische Ionenabgabe sowie Angaben zur Verpackung und Kennzeichnung.
Dieses Dokument gilt für Brackets und Röhrchen, die für festsitzende kieferorthopädische Apparaturen verwendet werden.
In diesem Dokument werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt, die in ISO 10993 1 und ISO 7405 beschrieben werden.

Médecine bucco-dentaire - Consoles et tubes utilisés en orthodontie (ISO 27020:2019)

Le présent document spécifie des exigences et des méthodes d'essai permettant de comparer les dimensions fonctionnelles des consoles et tubes orthodontiques et leur relargage d'ions chimiques, ainsi que des informations relatives au conditionnement et à l'étiquetage.
Le présent document s'applique aux consoles et tubes à utiliser sur les appareils orthodontiques fixes.
Le présent document ne comprend aucune exigence qualitative et quantitative relative à l'absence de risque biologique, celles-ci sont traitées par l'ISO 10993‑1 et l'ISO 7405.

Zobozdravstvo - Nastavki in cevke za uporabo v ortodontiji (ISO 27020:2019)

Ta dokument določa pogoje za vrste mikroleč. Uporablja se za vrste mikroleč, ki so sestavljene iz zelo majhnih leč znotraj ali na eni ali več površinah običajnega substrata. Dokument se uporablja tudi za sisteme vrst mikroleč.

General Information

Status
Published
Public Enquiry End Date
19-Apr-2018
Publication Date
18-Jul-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jul-2019
Due Date
15-Sep-2019
Completion Date
19-Jul-2019

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SLOVENSKI STANDARD
SIST EN ISO 27020:2019
01-september-2019
Nadomešča:
SIST EN ISO 27020:2011
Zobozdravstvo - Nastavki in cevke za uporabo v ortodontiji (ISO 27020:2019)
Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)
Zahnheilkunde - Brackets und Röhrchen für die Kieferorthopädie (ISO 27020:2019)

Médecine bucco-dentaire - Consoles et tubes utilisés en orthodontie (ISO 27020:2019)

Ta slovenski standard je istoveten z: EN ISO 27020:2019
ICS:
11.060.20 Zobotehnična oprema Dental equipment
SIST EN ISO 27020:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 27020:2019
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SIST EN ISO 27020:2019
EN ISO 27020
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 27020:2010
English Version
Dentistry - Brackets and tubes for use in orthodontics (ISO
27020:2019)

Médecine bucco-dentaire - Consoles et tubes utilisés en Zahnheilkunde - Brackets und Röhrchen für die

orthodontie (ISO 27020:2019) Kieferorthopädie (ISO 27020:2019)
This European Standard was approved by CEN on 10 May 2019.

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, Turkey 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

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 27020:2019 E

worldwide for CEN national Members.
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SIST EN ISO 27020:2019
EN ISO 27020:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 27020:2019
EN ISO 27020:2019 (E)
European foreword

This document (EN ISO 27020:2019) 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 January 2020, and conflicting national standards shall

be withdrawn at the latest by January 2020.

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 27020:2010.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 27020:2019 has been approved by CEN as EN ISO 27020:2019 without any modification.

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SIST EN ISO 27020:2019
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SIST EN ISO 27020:2019
INTERNATIONAL ISO
STANDARD 27020
Second edition
2019-06
Dentistry — Brackets and tubes for
use in orthodontics
Médecine bucco-dentaire — Consoles et tubes utilisés en orthodontie
Reference number
ISO 27020:2019(E)
ISO 2019
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SIST EN ISO 27020:2019
ISO 27020:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 27020:2019
ISO 27020:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 3

4.1 Hazardous elements ........................................................................................................................................................................... 3

4.2 Dimensions and angles .................................................................................................................................................................... 4

4.3 Release ........................................................................................................................................................................................................... 4

5 Test methods ............................................................................................................................................................................................................. 4

5.1 Dimensions ................................................................................................................................................................................................. 4

5.1.1 Apparatus ............................................................................................................................................................................... 4

5.1.2 Measurement procedures ........................................................................................................................................ 4

5.2 Static immersion corrosion test method .......................................................................................................................... 9

5.2.1 Apparatus ............................................................................................................................................................................... 9

5.2.2 Samples .................................................................................................................................................................................... 9

5.2.3 Test procedure ................................................................................................................................................................10

5.3 Treatment of results ........................................................................................................................................................................10

6 Packaging and labelling information to be provided to the user ...................................................................10

6.1 General requirements ....................................................................................................................................................................10

6.2 Packaging ..................................................................................................................................................................................................10

6.3 Labelling ....................................................................................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................12

© ISO 2019 – All rights reserved iii
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SIST EN ISO 27020:2019
ISO 27020:2019(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.

ISO 27020 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and

restorative materials.

This second edition cancels and replaces the first edition ISO 27020:2010, which has been technically

revised. The main changes compared to the previous edition are as follows:
— the inclusion of a new corrosion test.

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 2019 – All rights reserved
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SIST EN ISO 27020:2019
ISO 27020:2019(E)
Introduction

This document has been developed as a result of the difficulty often encountered by clinicians to make

meaningful comparisons between brackets and tubes using the information currently available from

manufacturers and suppliers.
© ISO 2019 – All rights reserved v
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SIST EN ISO 27020:2019
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SIST EN ISO 27020:2019
INTERNATIONAL STANDARD ISO 27020:2019(E)
Dentistry — Brackets and tubes for use in orthodontics
1 Scope

This document specifies requirements and test methods to compare the functional dimensions of

orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling

information.

This document is applicable to brackets and tubes for use in fixed orthodontic appliances.

This document does not specify specific qualitative and quantitative requirements for freedom from

biological hazards; which are covered in ISO 10993-1 and ISO 7405.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 10271:2011, Dentistry — Corrosion test methods for metallic materials
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
angle of torque

occlusal-gingival angle formed between the intersection of the line perpendicular to the tangent to the

tooth side surface of the base and the line bisecting the slot (3.12) in the occlusal-gingival direction,

when viewed along the mesial-distal long-axis of the slot (3.12)

Note 1 to entry: If the angle is oriented toward the occlusal (gingival), it is designated as positive (negative).

Note 2 to entry: See Figure 1.
3.2
angulation

angle between the line perpendicular to the mesial-distal long-axis of the slot and the central occlusal-

gingival axis of the bracket/tube (3.9), when viewed from the buccal/labial

Note 1 to entry: The angulation is positive (negative) when the gingival part of the central occlusal-gingival axis

is inclined toward the di
...

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