Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)

ISO 22674:2016 classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party.
ISO 22674:2016 does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).

Zahnheilkunde - Metallische Werkstoffe für festsitzenden und herausnehmbaren Zahnersatz und Applikationen (ISO 22674:2016)

Diese Internationale Norm teilt metallische Werkstoffe, die zur Herstellung von dentalen Restaurationen und
Applikationen geeignet sind, einschließlich der metallischen Werkstoffe, die für eine Anwendung mit oder
ohne Keramikverblendung oder für beide Anwendungen empfohlen werden, in Typen ein und legt deren
Anforderungen fest. Darüber hinaus werden Anforderungen an die Verpackung und Kennzeichnung der
Produkte sowie an die mit der Anwendung dieser Werkstoffe und die für einen Verkauf der Produkte an
Dritte zur Verfügung zu stellenden Anweisungen festgelegt.
Diese Internationale Norm gilt nicht für Legierungen für dentale Amalgame (ISO 24234), dentale Hartlote
(ISO 9333) oder für metallische Werkstoffe für kieferorthopädische Apparaturen (ISO 15841) (z. B. Drähte,
Brackets, Bänder und Schrauben).

Médecine bucco-dentaire - Matériaux métalliques pour les restaurations fixes et amovibles et les appareillages (ISO 22674:2016)

ISO 22674:2016 spécifie une classification des matériaux métalliques appropriés à la fabrication de restaurations dentaires et des appareils, y compris les matériaux métalliques d'utilisation recommandée avec ou sans revêtement céramique, ou indifféremment pour ces deux utilisations, et spécifie les exigences qui leur sont applicables. De plus, elle précise les exigences relatives au conditionnement et au marquage des produits et les instructions à fournir pour l'utilisation de ces matériaux, y compris les produits commercialisés à des tiers.
ISO 22674:2016 ne s'applique pas aux alliages pour amalgame dentaire (ISO 24234), aux produits pour brasage dentaire (ISO 9333) ni aux matériaux métalliques destinés aux appareils orthodontiques (ISO 15841) (par exemple fils métalliques, supports, bagues et vis).

Zobozdravstvo - Kovinski materiali za stalne in zamenljive zobne obnove in orodja (ISO 22674:2016)

Ta dokument temelji na zahtevah standarda ETSI TS 102 656 [2].
Ta dokument zajema izročilne zahteve in izročilno specifikacijo za podatke, ki jih obravnavajo nacionalni zakoni o zadržanih podatkih.
Ta dokument obravnava zahtevanje zadržanih podatkov in izročanje rezultatov.
Ta dokument določa elektronski vmesnik. Informativni dodatek opisuje, kako se lahko ta vmesnik prilagodi za ročne postopke. Ročni postopki v tem dokumentu niso obravnavani, razen v dodatku I.

General Information

Status
Withdrawn
Publication Date
23-Feb-2016
Withdrawal Date
20-Sep-2022
Technical Committee
Drafting Committee
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
21-Sep-2022

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SLOVENSKI STANDARD
SIST EN ISO 22674:2016
01-april-2016
1DGRPHãþD
SIST EN ISO 22674:2007
Zobozdravstvo - Kovinski materiali za stalne in zamenljive zobne obnove in orodja
(ISO 22674:2016)
Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO
22674:2016)
Zahnheilkunde - Metallische Werkstoffe für festsitzende und herausnehmbare
Restaurationen (ISO 22674:2016)
Médecine bucco-dentaire - Matériaux métalliques pour les restaurations fixes et
amovibles et les appareillages (ISO 22674:2016)
Ta slovenski standard je istoveten z: EN ISO 22674:2016
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 22674:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22674:2016

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SIST EN ISO 22674:2016


EN ISO 22674
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2016
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 22674:2006
English Version

Dentistry - Metallic materials for fixed and removable
restorations and appliances (ISO 22674:2016)
Médecine bucco-dentaire - Matériaux métalliques pour Zahnheilkunde - Metallische Werkstoffe für
les restaurations fixes et amovibles et les appareillages festsitzenden und herausnehmbaren Zahnersatz und
(ISO 22674:2016) Applikationen (ISO 22674:2016)
This European Standard was approved by CEN on 24 October 2015.

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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22674:2016 E
worldwide for CEN national Members.

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SIST EN ISO 22674:2016
EN ISO 22674:2016 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 22674:2016
EN ISO 22674:2016 (E)
European foreword
This document (EN ISO 22674:2016) 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 August 2016, and conflicting national standards shall
be withdrawn at the latest by August 2016.
This document supersedes EN ISO 22674:2006.
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.
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 22674:2016 has been approved by CEN as EN ISO 22674:2016 without any modification.
3

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SIST EN ISO 22674:2016

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SIST EN ISO 22674:2016
INTERNATIONAL ISO
STANDARD 22674
Second edition
2016-01-15
Dentistry — Metallic materials for
fixed and removable restorations
and appliances
Médecine bucco-dentaire — Matériaux métalliques pour les
restaurations fixes et amovibles et les appareillages
Reference number
ISO 22674:2016(E)
©
ISO 2016

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SIST EN ISO 22674:2016
ISO 22674:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 22674:2016
ISO 22674:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 3
5 Requirements . 4
5.1 Chemical composition . 4
5.1.1 Reported composition . 4
5.1.2 Permitted deviation from the reported composition for elements . 4
5.2 Hazardous elements . 4
5.2.1 Hazardous elements . 4
5.2.2 Limits for the hazardous elements cadmium and beryllium . 4
5.2.3 Limit for lead . 4
5.2.4 Nickel . 5
5.3 Biocompatibility . 5
5.4 Mechanical properties . 5
5.4.1 General. 5
5.4.2 Proof stress of 0,2 % non-proportional extension . 6
5.4.3 Elongation after fracture . 6
5.5 Elastic modulus . 7
5.5.1 Precision of measurement method . 7
5.5.2 Determination of compliance with the requirements for Type 5 materials. 7
5.5.3 Mean value . 8
5.6 Density . 8
5.7 Corrosion resistance for material integrity . 8
5.8 Tarnish resistance . 8
5.9 Solidus and liquidus temperatures (alloy) or melting point (commercially pure metal) . 8
5.10 Thermal expansion coefficient . 8
5.11 Information, instructions and marking . 9
6 Sampling . 9
7 Preparation of test specimens . 9
7.1 General . 9
7.2 Heat treatment . 9
7.2.1 General conditions . 9
7.2.2 Metallic materials for which a heat treatment is recommended in the
manufacturer’s instructions for use . 9
7.2.3 Metallic material for metal-ceramic restorations . 9
7.2.4 Metallic materials for which no heat-treatment is recommended in the
manufacturer’s instructions for use . 9
7.3 Proof stress of 0,2 % non-proportional extension and the elongation after fracture:
Metallic materials for which production of conventional specimens is possible .10
7.4 Type 0 metallic materials for which the production of conventional specimens is
not possible .11
7.5 Elastic moduli .11
7.5.1 General.11
7.5.2 Tensile strain method .11
7.5.3 Flexure method (three or four point bending) .11
7.5.4 Acoustic resonance method .12
7.6 Density measurement .13
7.7 Corrosion resistance .13
7.8 Tarnish resistance and colour .13
© ISO 2016 – All rights reserved iii

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SIST EN ISO 22674:2016
ISO 22674:2016(E)

7.9 Linear thermal expansion .13
8 Test methods .13
8.1 Information, instructions and marking .13
8.2 Chemical composition .14
8.3 Mechanical testing .14
8.3.1 Apparatus .14
8.3.2 Test procedure .14
8.4 Proof stress of 0,2 % non-proportional extension .15
8.4.1 Calculation .15
8.4.2 Mean value .15
8.5 Percentage elongation after fracture .15
8.5.1 Calculation .15
8.5.2 Mean value .15
8.6 Elastic modulus measurement .15
8.6.1 Tensile strain method .15
8.6.2 Flexure method in three- or four-point bending mode .16
8.6.3 Acoustic resonance method .18
8.7 Calculation of elasticity parameters from acoustic measurement .19
8.7.1 General.19
8.7.2 Elastic modulus .20
8.7.3 Shear modulus .20
8.7.4 Poisson ratio .21
8.8 Density .21
8.8.1 Preparation of test specimens .21
8.8.2 Reagents .21
8.8.3 Apparatus .21
8.8.4 Procedure .21
8.9 Corrosion resistance by the static immersion procedure of ISO 10271:2011 .21
8.9.1 Preparation of test specimens .21
8.9.2 Reagents .21
8.9.3 Apparatus .21
8.9.4 Test solution.22
8.9.5 Test procedure .22
8.9.6 Analysis .22
8.9.7 Treatment of data .22
8.10 Sulfide tarnish test (cyclic immersion) .22
8.11 Sulfide tarnish test (static immersion) .22
8.12 Solidus and liquidus temperatures (dental casting alloys) or melting point
(commercially pure metals) .22
8.12.1 Cooling curve method.22
8.12.2 Thermal analysis method .23
8.13 Linear thermal expansion .24
9 Information and instructions for use .24
9.1 Information .24
9.2 Processing instructions .25
10 Marking and labelling .25
10.1 Marking .25
10.2 Labelling of the package .25
Annex A (informative) Tensile testing of a non-cast Type 0 metallic material that is
intended for use in a thickness between 0,1 mm and 0,5 mm .27
Annex B (normative) Calculation of uncertainty for elasticity measurement .30
Annex C (informative) Measurement of Poisson ratio .34
Bibliography .36
iv © ISO 2016 – All rights reserved

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SIST EN ISO 22674:2016
ISO 22674:2016(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 2,
Prosthodontic materials.
This second edition cancels and replaces the first edition (ISO 22674:2006), which has been technically
revised with the following changes:
— Corrosion resistance measurement was referred to the recent standard ISO 10271:2011.
— A second tarnish test was included, referring to provisions in ISO 10271:2011.
— Clarification of the term “free of“ was added to the requirements of composition and labelling;
— Lead was added as a hazardous element.
— Measurement of elasticity was revised. Beside the method of calculation of elastic modulus using
an extensometer, other alternative methods were added, namely, the flexure method in three- and
four-point bending and the acoustic resonance method.
— Informative Annex A was added, dealing with tensile testing of non-cast Type 0 metallic materials
intended for use in a thickness between 0,1 and 0,5 mm.
— Normative Annex B was added, giving information on calculation of uncertainty for elastic
measurement.
— Informative Annex C was added, giving information for measurement of Poisson ratio.
© ISO 2016 – All rights reserved v

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SIST EN ISO 22674:2016
ISO 22674:2016(E)

Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this International Standard, but it is recommended that, in assessing possible biological hazards,
reference has to be made to ISO 10993-1 and ISO 7405.
Requirements for the performance of metals and alloys used for the metallic component of a metal-
ceramic restoration contained in this International Standard supersede such requirements formerly
contained in ISO 9693. The requirements for the performance of ceramic material and the metal-
ceramic bond in metal-ceramic restorative systems continue to be specified in ISO 9693-1.
Requirements for the proof stress and minimum elongation after fracture for Type 0 metallic materials
are not included in this International Standard, but it is recommended to adopt the test procedure
given in Annex A when measuring these properties. Requirements will be included in a revision of this
International Standard when information becomes available to Technical Committee ISO/TC 106/SC 2.
vi © ISO 2016 – All rights reserved

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SIST EN ISO 22674:2016
INTERNATIONAL STANDARD ISO 22674:2016(E)
Dentistry — Metallic materials for fixed and removable
restorations and appliances
1 Scope
This International Standard classifies metallic materials that are suitable for the fabrication of dental
restorations and appliances, including metallic materials recommended for use either with or without
a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it
specifies requirements with respect to packaging and marking the products and to the instructions to
be supplied for the use of these materials, including products delivered for sale to a third party.
This International Standard does not apply to alloys for dental amalgam (ISO 24234), dental brazing
materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets,
bands and screws).
2 Normative references
The follow
...

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