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-Jan-2026
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
21-Sep-2022
Completion Date
28-Jan-2026

Relations

Effective Date
15-Feb-2012
Effective Date
28-Sep-2022
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Standard

EN ISO 22674:2016

English language
45 pages
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Frequently Asked Questions

EN ISO 22674:2016 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)". This standard covers: 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).

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).

EN ISO 22674:2016 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 22674:2016 has the following relationships with other standards: It is inter standard links to EN ISO 22674:2006, EN ISO 22674:2022, EN 12490:2010, EN ISO 385:2005, EN ISO 16000-11:2006, EN ISO 10580:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 22674:2016 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN ISO 22674:2016 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


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

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.

Contents Page
European foreword . 3

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.
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
ISO 22674:2016(E)
© 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

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 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

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 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

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 following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 3696, Water for analytical laboratory use — Specification and test methods
ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
1)
ISO 5832-3 , Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium
4-vanadium alloy
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
2)
, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ISO 6892-1
ISO 9513, Metallic materials — Calibration of extensometer systems used in uniaxial testing
ISO 9693-1, Dentistry — Compatibility testing — Part 1: Metal-ceramic systems
ISO 10271:2011, Dentistry — Corrosion test methods for metallic materials
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions of ISO 1942 and the following apply.
3.1
base metal
any metallic element with the exception of noble metals (i. e. gold and metals of the platinum group)
and silver
1) To be published.
2) To be published.
ISO 22674:2016(E)
3.2
noble metal
gold and metals of the platinum group
[SOURCE: ISO 1942:2009, 2.187]
3.3
hazardous element
element that is known for its potential to produce an adverse biological effect
Note 1 to entry: The presence of such an element (as an alloying addition or as an impurity) in a dental alloy does
not imply that the alloy, in itself, is hazardous.
3.4
metallic material
material having the properties that are associated with an alloy, noble metal or base metal
Note 1 to entry: This may be a pure element, commercially pure metal or an alloy.
3.5
casting alloy
metallic material designed for casting into an investment mould
3.6
ceramic veneer
thin ceramic surface layer present on a metallic material restoration to provide an aesthetic effect
3.7
metal-ceramic restoration
dental restoration in which a ceramic veneer is bonded to a metallic material substructure by firing
Note 1 to entry: This can apply also to the metallic material used for such a restoration. In this context, metal-
ceramic alloy is a synonym.
Note 2 to entry: If recommended, such a metallic material may be used without a ceramic veneer.
3.8
metallic base
metal with highest concentration by mass fraction in the alloy
Note 1 to entry: The name of this element shall precede the words “-based metallic material for dental restoration”
or “-based dental casting alloy” or “-based dental metal-ceramic material”, as is appropriate.
3.9
base-metal alloy
alloy having a base metal as the principal element
3.10
as-cast condition
metallurgical condition of the metallic material in its solid state when removed from the casting machine
Note 1 to entry: This condition is dependent upon the manufacturer’s recommended cooling procedure (e.g.
bench cooling).
3.11
bench-cooling
process whereby a casting is retained in its investment with exposed metal uppermost and placed
on a flat, insulating surface at ambient temperature in freely circulating air until its temperature
falls to ambient
2 © ISO 2016 – All rights reserved

ISO 22674:2016(E)
3.12
hardening
heat-treatment of a metallic material producing a condition which provides a higher 0,2 % proof stress
than the “as-cast” state
Note 1 to entry: If recommended by the manufacturer, explicit instructions shall be given in the instructions for use.
3.13
softening
heat-treatment of a metallic material producing a condition which provides a lower 0,2 % proof stress
than the “as-cast” state
Note 1 to entry: If recommended by the manufacturer, explicit instructions shall be given in the instructions for use.
3.14
one-surface inlay
an inlay restoration that is exposed to the oral environment on one and no more of the surfaces that are
used to define the tooth for the purposes of charting
3.15
elastic modulus
E
the ratio of elastic stress to elastic strain, also termed tensile elastic modulus or Young’s modulus,
symbol E
4 Classification
For the purposes of this International Standard, a metallic material is classified according to its
mechanical properties by a Type number, of which there are six.
Examples of the applications for which these Types are intended are as follows:
— Type 0: intended for low stress bearing single-tooth fixed prostheses, e.g. small veneered one-
surface inlays, veneered crowns;
NOTE Metallic materials for metal-ceramic crowns produced by electroforming or sintering belong to
Type 0.
— Type 1: for low stress bearing single-tooth fixed prostheses, e.g. veneered or unveneered one-
surface inlays, veneered crowns;
— Type 2: for single tooth fixed prostheses, e.g. crowns or inlays without restriction on the number of
surfaces;
— Type 3: for multiple unit fixed prostheses;
— Type 4: for appliances with thin sections that are subject to very high forces, e.g. removable partial
dentures, clasps, thin veneered single crowns, full arch fixed dental prostheses or those with small
cross-sections, bars, attachments, implant retained superstructures;
— Type 5: for appliances in which parts require the combination of high stiffness and proof stress, e.g.
thin removable partial dentures, parts with thin cross-sections, clasps.
NOTE 1 The higher application type can include lower application types.
NOTE 2 Multiple-unit and full-arch, fixed dental prostheses are also referred to as bridges.
ISO 22674:2016(E)
5 Requirements
5.1 Chemical composition
5.1.1 Reported composition
For all elements that are present in excess of 1,0 % (mass fraction), each constituent element shall be
declared by the manufacturer and shall be reported [see 9.1 a)] to a precision of 0,1 % (mass fraction).
Any element that is present in excess of 0,1 % (mass fraction), but not of 1,0 % (mass fraction), shall be
identified in [see 9.1 a)] either by name or symbol.
EXAMPLE If a constituent element is present with 0,6 % (mass fraction), it shall be identified [9.1 a)] either
by name or symbol. If a constituent element is present with 22,06 % (mass fraction), it shall be reported [9.1 a)]
as 22,1 % [precision of 0,1 % (mass fraction)].
If the metallic material contains less than 0,1 % (mass fraction) of a specified element (other than one
named in 5.2), it may be named as “free of“ this specified element [see 9.1 p) and 10.2 h)].
5.1.2 Permitted deviation from the reported composition for elements
The permitted deviation of the reported composition for elements from the value stated on the package
or label or insert [see 9.1 a)] is given in Table 1.
Table 1 — Permitted deviation from the reported composition for elements
Alloy Elemental content
1,0 % < mass fraction ≤ 20 % mass fraction > 20 %
Base-metal alloy max. 1,0 % max. 2,0 %
Silver-based and noble metal alloy max. 0,5 % max. 0,5 %
5.2 Hazardous elements
5.2.1 Hazardous elements
For the purposes of this International Standard, the elements nickel, cadmium, beryllium and lead are
designated to be hazardous elements.
5.2.2 Limits for the hazardous elements cadmium and beryllium
The metallic material shall not contain more than 0,02 % (mass fraction) cadmium or beryllium.
Cadmium and beryllium are neither alloying elements nor elements inherent to the manufacturing
process of titanium metallic materials. For titanium metallic materials that comply with the
requirements of chemical composition of ISO 5832-2 and ISO 5832-3, cadmium and beryllium do not
need to be analysed.
5.2.3 Limit for lead
The metallic material shall not contain more than 0,02 % (mass fraction) lead.
Lead is neither an alloying elements nor an element inherent to the manufacturing process of titanium
metallic materials. For titanium metallic materials that comply with the requirements of chemical
composition of ISO 5832-2 and ISO 5832-3, lead does not need to be analysed.
4 © ISO 2016 – All rights reserved

ISO 22674:2016(E)
5.2.4 Nickel
5.2.4.1 Manufacturer’s reported nickel content and permitted deviation
If the metallic material contains more than 0,1 % (mass fraction) nickel, this content shall be given to
an accuracy of 0,1 % (mass fraction) in the literature which accompanies the package [see 9.1 n)] and on
the package, label or insert [see 10.2 f)].
The mass fraction shall not exceed the value stated in 9.1 n) and 10.2 f).
5.2.4.2 Nickel-free products
For the purposes of this International Standard, alloys with a maximum of 0,1 % (mass fraction) nickel
can be labelled “nickel free” [see 9.1 o) and 10.2 g)].
If nickel is not declared, it must be limited to a maximum of 0,1 %. This limit has to be adhered to when
nickel is a natural impurity in a component of the alloy.
5.3 Biocompatibility
For guidance on biocompatibility, see Introduction.
5.4 Mechanical properties
5.4.1 General
This requirement (see Table 2) shall be met by the metallic material after the recommended processing
techniques (e.g. casting, bench-cooling, machining) and after the ceramic firing schedule (if appropriate)
have been applied. A metallic material recommended for use either with or without a ceramic veneer
shall meet this requirement in both metallurgical conditions.
If a heat-treatment is recommended by the manufacturer [see 9.2 c)] this requirement shall be met by the
material in the heat-treated condition, applied in accordance with the manufacturer’s instructions for use.
For a metallic material, the Type can be classified differently (according to Table 2) if it is recommended
for use in more than one metallurgical condition (produced by alternative processing schedules). The
highest applicable Type shall be specified for each condition.
Table 2 — Mechanical properties
Proof stress of 0,2 %
Elongation after
non-proportional extension
Elastic modulus
fracture
R
p0,2
Type GPa
%
MPa
minimum
minimum
minimum
0 — — —
1 80 18 —
2 180 10 —
3 270 5 —
4 360 2 —
5 500 2 150
Testing shall be done according to 8.3.
ISO 22674:2016(E)
5.4.2 Proof stress of 0,2 % non-proportional extension
5.4.2.1 Determination of compliance
Refer to the classification Type stated in 9.1 b).
If four, five or six of the results for the set of six specimens in the first test series meet the requirement for
proof stress of 0,2 % non-proportional extension, the metallic material complies with the requirement.
If two or fewer of the results for the set of six specimens in the first test series meet the requirement
for proof stress of 0,2 % non-proportional extension, the metallic material fails to comply with the
requirement.
NOTE 1 Two lots of six specimens are produced (see Clause 7). One of these lots is tested in the first test series.
If required, replacement specimens are drawn from the second lot and used in the first test series. The remaining
specimens in the second lot form the second test series.
NOTE 2 In this context, the number six is reached to complete the set in the first test series when the number
of specimens tested less those rejected after post fracture examination (8.3.2) is six, (i.e. replacement specimens
are included in the total).
If three or four specimens in the first lot of six specimens are rejected on the basis of 8.3.2 and replaced
with specimens from the second lot, all 12 specimens shall be tested. If at least eight results meet the
requirement for proof stress of 0,2 % non-proportional extension, the metallic material complies with
the requirement.
If three of the results for the set of six specimens in the first test series meet the requirement for proof
stress of 0,2 % non-proportional extension, all remaining specimens shall be tested in a second test
series. If five or six of the results for the specimens in the second test series meet the requirement for
proof stress of 0,2 % non-proportional extension, the metallic material complies with the requirement.
Under this compliance criterion, if one specimen from the first lot has been rejected on the basis of
inspection after fracture (8.3.2) during the first test series and a specimen from the second lot of
six used as its replacement, then all five remaining specimens in the second series shall meet the
requirement. Only one replacement is possible for a borderline metallic material.
If three of the results for the first set of six specimens in the first test series meet the requirement for
proof stress of 0,2 % non-proportional extension and four or fewer of the results from the specimens in
the second test series meet the requirement for proof stress of 0,2 % non-proportional extension, the
metallic material fails to comply with the requirement.
Testing shall be done according to 8.3.2.
5.4.2.2 Mean value
The mean value for the proof stress of 0,2 % non-proportional extension, calculated according to 8.4.2
shall not differ by more than 10 % from the value given in the literature accompanying the package
[see 9.1 c)].
5.4.3 Elongation after fracture
5.4.3.1 Determination of compliance with the requirement
Refer to the classification Type stated in 9.1 b).
If the four, five or six of the results for the set of six specimens in the first test series that meet the
requirement for proof stress of 0,2 % non-proportional extension also meet the requirement for elongation
after fracture, the metallic material complies with the requirement for elongation after fracture.
6 © ISO 2016 – All rights reserved

ISO 22674:2016(E)
If two or fewer of the results for the set of six specimens in the first test series meet the requirement
for elongation after fracture, the metallic material fails to comply with the requirement for elongation
after fracture.
NOTE 1 Two lots of six specimens are produced (see Clause 7). One of these lots is tested in the first test series.
If required, replacement specimens are drawn from the second lot and used in the first test series. The remaining
specimens in the second lot form the second test series.
NOTE 2 In this context, the number six is reached to complete the set in the first test series when the number
of specimens
...

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