SIST EN ISO 22674:2007
(Main)Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2006)
Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2006)
This International Standard classifies metallic materials that are suitable for the fabrication of dental appliances and restorations, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials. 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., wire, bracket, band and screw).
Zahnheilkunde - Metallische Werkstoffe für festsitzenden und herausnehmbaren Zahnersatz und Vorrichtungen (ISO 22674:2006)
Diese Internationale Norm teilt metallische Werkstoffe, die zur Herstellung von dentalen Vorrichtungen und Zahnersatz geeignet sind, einschließlich der metallischen Werkstoffe, die für eine Anwendung mit oder ohne Keramikverblendung bzw. für beide Anwendungen empfohlen werden, in Typen ein und legt deren Anforderungen fest. Darüber hinaus werden Anforderungen an die Verpackung und Kennzeichnung des Produktes sowie an die mit der Anwendung dieser Werkstoffe 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 die Kieferorthopädie (ISO 15841) (z. B. Draht, Bracket, Band und Schraube).
Art dentaire - Matériaux métalliques pour les restaurations fixes et amovibles et les appareillages (ISO 22674:2006)
L'ISO 22674:2006 spécifie une classification des matériaux métalliques convenant à la fabrication des appareils et aux restaurations dentaires, y compris les matériaux métalliques d'utilisation recommandée soit avec revêtement céramique, soit sans revêtement céramique ou indifféremment avec ou sans, et spécifie les exigences qui leur sont applicables. Elle précise par ailleurs les exigences relatives au conditionnement et au marquage des produits et les instructions à fournir pour l'utilisation de ces matériaux.
Zobozdravstvo - Kovinski materiali za stalne in zamenljive zobne obnove in orodja (ISO 22674:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22674:2007
01-marec-2007
1DGRPHãþD
SIST EN ISO 1562:2004
SIST EN ISO 16744:2004
SIST EN ISO 6871-1:2000
SIST EN ISO 6871-1:2000/AC:2003
SIST EN ISO 6871-2:2000
SIST EN ISO 8891:2000
Zobozdravstvo - Kovinski materiali za stalne in zamenljive zobne obnove in orodja
(ISO 22674:2006)
Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO
22674:2006)
Zahnheilkunde - Metallische Werkstoffe für festsitzenden und herausnehmbaren
Zahnersatz und Vorrichtungen (ISO 22674:2006)
Art dentaire - Matériaux métalliques pour les restaurations fixes et amovibles et les
appareillages (ISO 22674:2006)
Ta slovenski standard je istoveten z: EN ISO 22674:2006
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 22674:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 22674
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2006
ICS 11.060.10 Supersedes EN ISO 1562:2004, EN ISO 16744:2003, EN
ISO 6871-1:1996, EN ISO 6871-2:1996, EN ISO
8891:2000
English Version
Dentistry - Metallic materials for fixed and removable
restorations and appliances (ISO 22674:2006)
Art dentaire - Matériaux métalliques pour les restaurations Zahnheilkunde - Metallische Werkstoffe für festsitzenden
fixes et amovibles et les appareillages (ISO 22674:2006) und herausnehmbaren Zahnersatz und Vorrichtungen (ISO
22674:2006)
This European Standard was approved by CEN on 28 October 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22674:2006: E
worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 22674:2006 (E)
Foreword
This document (EN ISO 22674:2006) 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 document supersedes EN ISO 1562:2004, EN ISO 6871-1:1996, EN ISO 6871-1:1996, EN
ISO 8891:2000 and EN ISO 16744:2003.
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 May 2007, and conflicting national standards
shall be withdrawn at the latest by May 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,
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 22674:2006 has been approved by CEN as EN ISO 22674:2006 without any
modifications.
2
---------------------- Page: 3 ----------------------
INTERNATIONAL ISO
STANDARD 22674
First edition
2006-11-15
Dentistry — Metallic materials for fixed
and removable restorations and
appliances
Art dentaire — Matériaux métalliques pour les restaurations fixes et
amovibles et les appareillages
Reference number
ISO 22674:2006(E)
©
ISO 2006
---------------------- Page: 4 ----------------------
ISO 22674:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 5 ----------------------
ISO 22674:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification. 3
5 Requirements . 3
5.1 Chemical composition. 3
5.2 Hazardous elements. 4
5.3 Biocompatibility. 4
5.4 Mechanical properties. 4
5.5 Density . 7
5.6 Corrosion resistance for material integrity. 7
5.7 Tarnish resistance . 8
5.8 Solidus and liquidus temperatures (for alloy) or melting point (for commercially pure
metal). 8
5.9 Thermal expansion coefficient . 8
5.10 Information, instructions and marking. 8
6 Sampling. 8
7 Preparation of test specimens . 9
7.1 General. 9
7.2 Heat-treatment. 9
7.3 Specimens . 9
8 Test methods. 11
8.1 Information, instructions and marking. 11
8.2 Chemical composition. 11
8.3 Mechanical properties. 12
8.4 Density . 13
8.5 Corrosion resistance. 14
8.6 Tarnish resistance (sodium sulfide test). 15
8.7 Solidus and liquidus temperatures (alloys) or melting point (commercially pure metals). 16
8.8 Linear thermal expansion . 16
9 Information and instructions for use. 16
9.1 Information . 16
9.2 Processing instructions. 17
10 Marking and labelling . 17
10.1 Marking . 17
10.2 Labelling on the package. 18
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 . 19
Bibliography . 22
© ISO 2006 – All rights reserved iii
---------------------- Page: 6 ----------------------
ISO 22674:2006(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 22674 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This first edition cancels and replaces the following composition-derived International Standards: ISO 1562,
ISO 6871-1, ISO 6871-2, ISO 8891 and ISO 16744.
iv © ISO 2006 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 22674:2006(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 should
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.
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 Subcommittee 2.
© ISO 2006 – All rights reserved v
---------------------- Page: 8 ----------------------
INTERNATIONAL STANDARD ISO 22674:2006(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
appliances and restorations, including metallic materials recommended for use either with or without a
ceramic veneer, or recommended for both uses, and specifies their requirements. It further specifies
requirements with respect to packaging and marking the products and to the instructions to be supplied for the
use of these materials.
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., wire, bracket, band and screw).
2 Normative references
The following referenced documents are indispensable for the application 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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 6892, Metallic materials — Tensile testing at ambient temperature
ISO 7500-1:2004, Metallic materials — Verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Verification and calibration of the force-measuring system
ISO 9513:1999, Metallic materials — Calibration of extensometers used in uniaxial testing
ISO 9693, Metal-ceramic dental restorative systems
ISO 10271:2001, Dental metallic materials — Corrosion test methods
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
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 and silver
© ISO 2006 – All rights reserved 1
---------------------- Page: 9 ----------------------
ISO 22674:2006(E)
3.2
hazardous element
element that is known for its potential to produce an adverse biological effect
NOTE 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 harmful.
3.3
metallic material
material having the properties that are associated with an alloy, noble metal or base metal
NOTE This may be a pure element, commercially pure metal or an alloy.
3.4
casting alloy
metallic material designed for casting into a dental investment mould
3.5
ceramic veneer
thin ceramic surface layer present on a metallic material restoration to provide an aesthetic effect
3.6
metal-ceramic
dental restoration in which a ceramic veneer is bonded to a metallic material substructure by firing
NOTE 1 This can apply also to the metallic material used for such a restoration. In this context metal-ceramic alloy is a
synonym.
NOTE 2 If recommended, such a metallic material may be used without a ceramic veneer.
3.7
metallic base
noble metal or base metal with highest concentration by mass fraction in the alloy
NOTE 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.
3.8
base-metal alloy
alloy having a base metal as the principal element
3.9
as-cast condition
metallurgical condition of the metallic material in its solid state after removal from the casting machine
NOTE This condition is dependent upon the manufacturer’s recommended cooling procedure (e.g., bench cooling).
3.10
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
3.11
hardening
heat-treatment producing a condition which provides a higher 0,2 % proof strength than the “as-cast” state
NOTE If recommended by the manufacturer, explicit instructions should be given in the instructions for use.
2 © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 22674:2006(E)
3.12
softening
heat-treatment producing a condition which provides a lower 0,2 % proof strength than the “as-cast” state
NOTE If recommended by the manufacturer, explicit instructions should be given in the instructions for use.
3.13
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
3.14
veneer
thin covering of surface material applied to a coarser base material
4 Classification
For the purposes of this International Standard a metallic material is classified, according to its mechanical
properties as 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 restorations, 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: intended for low stress bearing single-tooth fixed restorations, e.g. veneered or unveneered
one-surface inlays, veneered crowns.
— Type 2: intended for single tooth fixed restorations, e.g. crowns or inlays without restriction on the
number of surfaces.
— Type 3: intended for multiple unit fixed restorations, e.g. bridges.
— Type 4: intended for appliances with thin sections that are subject to very high forces, e.g. removable
partial dentures, clasps, thin veneered crowns, wide-span bridges or bridges with small cross-
sections, bars, attachments, implant retained superstructures.
— Type 5: intended for appliances in which parts require the combination of high stiffness and strength,
e.g. thin removable partial dentures, parts with thin cross-sections, clasps.
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 [see 9.1 a)] either by name or symbol.
© ISO 2006 – All rights reserved 3
---------------------- Page: 11 ----------------------
ISO 22674:2006(E)
5.1.2 Permitted deviation from the reported composition for elements
For silver-based or noble-metal alloys, the percentage of each of the constituents of the alloy shall not deviate
by more than 0,5 % (mass fraction) from the values stated on the package label or insert [see 9.1 a)].
For base-metal alloys, all elements present in excess of 20 % (mass fraction) shall not deviate by more than
2,0 % (mass fraction) from the value stated on the package or label or insert. Those present in excess of
1,0 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate by more than 1,0 % (mass
fraction) from the value stated on the package or label or insert [see 9.1 a)].
5.2 Hazardous elements
5.2.1 Recognized hazardous elements
For the purposes of this International Standard the elements nickel, cadmium and beryllium are designated
hazardous elements.
5.2.2 Permitted limits for the hazardous elements cadmium and beryllium
The metallic material shall not contain more than 0,02 % (mass fraction) cadmium or beryllium.
5.2.3 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).
5.3 Biocompatibility
See the introduction for guidance on biocompatibility.
5.4 Mechanical properties
5.4.1 General
Testing shall be done according to 8.3.2.
The requirements in Table 1 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 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 may be classified differently (according to Table 1) 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.
4 © ISO 2006 – All rights reserved
---------------------- Page: 12 ----------------------
ISO 22674:2006(E)
Table 1 — Mechanical properties
Proof strength of 0,2 %
Elongation after fracture Young’s modulus
non-proportional extension
R
Type p0,2
MPa % GPa
minimum minimum minimum
0 — — —
1 80 18 —
2 180 10 —
3 270 5 —
4 360 2 —
5 500 2 150
5.4.2 Proof strength 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 strength 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
strength of 0,2 % non-proportional extension, the metallic material fails to comply with the requirement.
NOTE 1 Two sets of six specimens are produced (see 7.3.1). One of these sets 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 set of six specimens are rejected on the basis of 8.3.2 and replaced with
specimens from the second set, all twelve specimens shall be tested. If at least eight results meet the
requirement for proof strength 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 strength
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 strength of 0,2 %
non-proportional extension, the metallic material complies with the requirement.
NOTE 3 Under this compliance criterion, if one specimen from the first set 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. N.B. Only one replacement is possible for a
borderline metallic material.
If three of the results for the set of six specimens in the first test series meet the requirement for proof strength
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 strength of 0,2 % non-proportional extension, the metallic material fails
to comply with the requirement.
© ISO 2006 – All rights reserved 5
---------------------- Page: 13 ----------------------
ISO 22674:2006(E)
5.4.2.2 Mean value
The mean value for the proof strength of 0,2 % non-proportional extension 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, which meet the
requirement for proof strength 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.
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 sets of six specimens are produced (see 7.3.1). One of these sets is tested in the first test series. If
required, replacement specimens are drawn from the second set and used in the first test series. The remaining
specimens in the second set 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 set of six specimens are rejected on the basis of 8.3.2 and replaced with
specimens from the second set, all twelve specimens shall be tested. If at least eight results of the specimens
that meet the requirement for proof strength of 0,2 % non-proportional extension also meet the requirement for
elongation to fracture, the metallic material complies with the requirement for elongation after fracture.
If three of the results for the first set of six specimens in the first test series, which meet the requirement for
proof strength of 0,2 % non-proportional extension also have an elongation after fracture that meets the
requirement for elongation after fracture, 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 have both an elongation after fracture and
a proof strength of 0,2 % non-proportional extension that meet both requirements, the metallic material
complies with the requirement for the perce
...
EUROPEAN STANDARD
DRAFT
prEN ISO 22674
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2005
ICS 11.060.10
English version
Dentistry - Metallic materials for fixed and removable dental
restorations and appliances (ISO/DIS 22674:2005)
Art dentaire - Produits dentaires pour les restaurations fixes
et amovibles et appareillages (ISO/DIS 22674:2005)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 55.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 22674:2005: E
worldwide for CEN national Members.
---------------------- Page: 1 ----------------------
prEN ISO 22674:2005 (E)
Foreword
This document (prEN ISO 22674:2005) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 22674:2005 has been approved by CEN as prEN ISO 22674:2005 without any
modifications.
2
---------------------- Page: 2 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 22674
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2005-04-14 2005-09-14
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Dentistry — Metallic materials for fixed and removable dental
restorations and appliances
Art dentaire — Produits dentaires métalliques pour les restaurations fixes et amovibles et appareillages
(Revision of ISO 1562:2004, ISO 6871-1:1994, ISO 6871-2:1994, ISO 8891:1998 and ISO 16744:2003)
ICS 11.060.10
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 NATIONAL REGULATIONS.
© International Organization for Standardization, 2005
---------------------- Page: 3 ----------------------
ISO/DIS 22674
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2005 – All rights reserved
---------------------- Page: 4 ----------------------
DIS_22674_2005.doc
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Classification. 3
5 Requirements. 3
5.1 Chemical composition. 3
5.2 Hazardous elements. 4
5.3 Biocompatibility. 4
5.4 Mechanical properties. 4
5.5 Density. 6
5.6 Corrosion resistance for material integrity. 6
5.7 Tarnish resistance. 6
5.8 Solidus and liquidus temperatures. 6
5.9 Thermal expansion coefficient . 7
5.10 Information, instructions and marking. 7
6 Sampling. 7
7 Preparation of test specimens . 7
7.1 General. 7
7.2 Heat-treatment. 7
7.3 Specimens. 8
8 Test methods. 10
8.1 Information, instructions and marking. 10
8.2 Chemical composition. 10
8.3 Mechanical properties. 10
8.4 Density. 11
8.5 Corrosion resistance. 12
8.6 Tarnish resistance (sodium sulphide test) . 13
8.7 Solidus and liquidus temperatures. 14
8.8 Linear thermal expansion. 14
9 Information and instructions for use. 14
9.1 Information. 14
9.2 Processing instructions. 15
10 Marking and Labelling. 15
10.1 Marking of dental metallic material. 15
10.2 Labelling on the package. 16
Annex A (normative) Tensile testing of non-cast metallic materials/products with a thickness
between 0,1 mm and 0,5 mm . 17
A.1 Preparation of test specimens . 17
A.1.1 Dimensions and tolerances . 17
A.1.2 Preparation of test pieces by electroforming . 17
A.1.3 Preparation of test pieces by sintering . 17
A.1.4 Preparation of test pieces by CAD/CAM techniques . 18
A.2 Testing. 18
A.2.1 Testing apparatus. 18
© ISO 2005 – All rights reserved iii
---------------------- Page: 5 ----------------------
DIS_22674_2005.doc
A.2.2 Conditions of testing . 18
A.2.3 Test procedure. 18
A.2.4 Determination of proof strength and elongation . 18
A.2.5 Evaluation. 19
A.2.6 Calculation of proof strength and elongation. 19
A.3 Test report. 19
Bibliography . 20
Figures
Figure 1 — Test specimen with conical shoulders.8
Figure 2 — Test specimen with radius shoulder.8
Figure A.1 — Proposed specimen geometry and dimensions.17
Tables
Table 1 — Mechanical properties .4
iv © ISO 2005 – All rights reserved
---------------------- Page: 6 ----------------------
DIS_22674_2005.doc
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 22674 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials. This is the first edition of this International Standard. This International Standard supersedes the
following International Standards which apply to dental casting alloys: ISO 1562, Dental casting gold alloys;
ISO 6871-1, Dental base metal casting alloys. — Part 1. Cobalt-based alloys; ISO 6871-2, Dental base metal
casting alloys. — Part 2. Nickel-based alloys; ISO 8891, Dental casting alloys with noble metal content of at
least 25% but less than 75%; and ISO 16744, Dentistry — Base metal materials for fixed dental restorations).
© ISO 2005 – All rights reserved v
---------------------- Page: 7 ----------------------
DIS_22674_2005.doc
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 should
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
dental restorative systems continue to be specified in ISO 9693.
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/TC106 Subcommittee 2.
vi © ISO 2005 – All rights reserved
---------------------- Page: 8 ----------------------
DRAFT INTERNATIONAL STANDARD DIS_22674_2005.doc
Dentistry — Metallic materials for fixed and removable dental
restorations and appliances
1 Scope
This International Standard classifies metallic materials that are suitable for the fabrication of dental appliances and
restorations, including metallic materials recommended for use either with or without a ceramic veneer, or recommended
for both uses, and specifies their requirements. It further specifies requirements with respect to packaging and marking the
products and to the instructions to be supplied for the use of these materials.
This International Standard does not apply to alloys for dental amalgam (ISO 24 234), dental brazing materials (ISO 9333),
nor metallic materials for orthodontic appliances (ISO 15841) (e.g., wire, bracket, band and screw).
2 Normative references
The following referenced documents are indispensable for the application 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 — Terminology
ISO 3585, Borosilicate glass 3.3 — Properties
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution tests
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 9333, Dentistry — Brazing materials
ISO 9693, Metal-ceramic dental restorative systems
ISO 10271, Dental metallic materials — Corrosion test methods
1
ISO 15841, Orthodontic metallic materials.
ISO 24234, Dentistry — Mercury and alloys for dental amalgam
3 Terms and definitions
For the purposes of this document, the terms and definitions of ISO 1942 and the following apply.
1
To be published
© ISO 2005 – All rights reserved 1
---------------------- Page: 9 ----------------------
DIS_22674_2005.doc
3.1
alloy
combination of two or more elements having metallic properties not existing in any of the single constituent
elements
3.2
noble metal
gold, platinum, palladium, ruthenium, iridium, osmium and rhodium
3.3
base metal
all metallic elements with the exception of noble metals and silver
3.4
hazardous element
an element that is known for its potential to produce an adverse biological effect. 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
harmful
3.5
metallic material
material having the properties that are associated with the metallic state. This may be a pure element,
commercially pure metal or an alloy
3.6
casting alloy
alloy designed for casting into a dental investment mould
3.7
metal-ceramic metallic material
dental metallic material on to which a ceramic veneer can be bonded by firing the ceramic. If recommended,
such a metallic material may be used without a ceramic veneer
3.8
metal-ceramic alloy
synonym for metal-ceramic metallic material, specifically restricted to an alloy
3.9
the base of a metallic material
the metallic element with highest concentration by mass fraction in the dental metallic material. The name of
this element shall precede the words “-based dental metallic material for restoration” or “-based dental casting
alloy” or “-based dental metal-ceramic metallic material”, as is appropriate
3.10
the base of an alloy
synonym for the base of a metallic material, specifically restricted to an alloy
3.11
noble-metal alloy
alloy having gold or elements of the platinum group as principal ingredients
3.12
base-metal alloy
alloy having a base metal as the principal element
3.13
as-cast state
condition of a casting when it has been allowed to bench cool to room temperature while remaining in the
investment mould without any further heat treatment
2 © ISO 2005 – All rights reserved
---------------------- Page: 10 ----------------------
DIS_22674_2005.doc
3.14
bench-cooling
process whereby a casting is retained in its investment with exposed metal uppermost and placed on a flat,
insulating surface in freely circulating air until its temperature falls to ambient
3.15
hardening
heat-treatment producing a state which provides a higher proof strength than the “as-cast” state. If
recommended by the manufacturer, explicit instructions must be given in the “instructions for use”
3.16
softening
heat-treatment producing a state which provides a lower proof strength than the “as-cast” state. If
recommended by the manufacturer, explicit instructions must be given in the “instructions for use”
3.17
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
4 Classification
For the purposes of this International Standard a dental metallic material is classified, according to its
mechanical properties as 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 single tooth fixed low stress restoration, e. g. veneered crown or small
veneered one-surface inlay.
— Type 1: intended for single tooth fixed low stress restoration, e. g. veneered or unveneered one-
surface inlay, veneered crown.
— Type 2: intended for single tooth fixed restoration, e. g. crown or inlay without restriction on the
number of surfaces.
— Type 3: Intended for multiple unit fixed restoration, e. g. bridge.
— Type 4: intended for appliances with thin sections that are subject to very high forces, e.g.
removable partial dentures, clasps, veneered single crowns, wide-span bridges or bridges
with small cross-sections, bars, attachments, implant retained superstructures.
— Type 5: intended for applications in which parts of the appliance require the combination of high
stiffness and strength, e.g. thin removable partial dentures, parts with thin cross-sections,
clasps.
5 Requirements
5.1 Chemical composition
5.1.1 Reported composition
For all elements that are present in excess of 1,0 % (mass fraction), the percentage by mass of each of the
constituent elements shall be declared by the manufacturer and shall be reported in 9.1 a) to a precision of
0,1 % (mass fraction).
Any element that is present in a concentration in excess of 0,1 % (mass fraction), but not in excess of 1 %
(mass fraction), shall be identified in 9.1 a) either by name or symbol.
© ISO 2005 – All rights reserved 3
---------------------- Page: 11 ----------------------
DIS_22674_2005.doc
5.1.2 Permitted deviation from the reported composition for elements
For gold-based or silver-based or noble-metal dental alloys the percentage of each of the constituents of the
alloy shall not deviate by more than 0,5 % (mass fraction) from the values stated on the package label or
insert [see 9.1 a)].
For dental base-metal based alloys, all elements, present with more than 20 % (mass fraction) shall not
deviate from the value stated on the package or label or insert by more than 2 % (mass fraction). Those
present in excess of 1 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate from the
value stated on the package or label or insert by more than 1 % (mass fraction) [see 9.1 a)].
5.2 Hazardous elements
5.2.1 Recognised hazardous elements
For the purposes of this International Standard the elements nickel, cadmium and beryllium are designated to
be hazardous elements.
5.2.2 Permitted limits for hazardous elements cadmium and beryllium
The metallic material shall not contain more than 0,02 % (mass fraction) cadmium or beryllium.
5.2.3 Reported composition of nickel and permitted deviation
If the metallic material contains more than 0,1 % (mass fraction) but less or equal to 1 % nickel this shall be
stated and the percentage by mass fraction shall be given to an accuracy of 0,1 % (mass fraction) in the
literature which accompanies the package [see 9.1 a)] and on the package, label or insert [see 10.2 i)].
The mass fraction shall not exceed the value stated in 9.1 a) and 10.2 i).
5.3 Biocompatibility
See the introduction for guidance on biocompatibility.
5.4 Mechanical properties
5.4.1 General
Table 1 — Mechanical properties
Proof strength of 0,2 % non-
Elongation after
proportional extension
Young’s modulus
fracture
Type
R
P0.2
GPa
%
MPa
min.
min.
min.
0 --- --- —
1 80 18 —
2 180 10 —
3 270 5 —
4 360 2 —
5 500 2 150
4 © ISO 2005 – All rights reserved
---------------------- Page: 12 ----------------------
DIS_22674_2005.doc
This requirement 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) has been applied. A
metallic material recommended for use either with or without a ceramic veneer shall meet this requirement in
both metallurgical states.
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 state, in accordance with the manufacturer’s “instructions for use”.
5.4.2 Proof strength 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 set of six specimens meet the requirement for proof strength of 0,2 % non-proportional
extension, the metallic material complies with the requirement.
If two or fewer of the set of six specimens meet the requirement for proof strength of 0.2% non-proportional
extension the metallic material fails to comply with the requirement.
If three specimens of the first set of six specimens meet the requirement for proof strength of 0,2 % non-
proportional extension and five or six of the second set of six specimens meet the requirement for proof
strength of 0,2 % non-proportional extension, the metallic material complies with the requirement. If four or
fewer specimens from the second set of six specimens meet the requirement for proof strength of 0,2 % non-
proportional extension, the metallic material fails to comply with the requirement.
5.4.2.2 Mean (reported) value
The mean value for the proof strength of 0,2 % non-proportional extension 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 set of six specimens that meet the requirement for proof strength 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.
If two or fewer of the set of six specimens meet the requirement for elongation after fracture, the metallic
material fails to comply with the requirement for elongation after fracture.
If three of the specimens that meet the requirement for proof strength of 0,2 % non-proportional extension also
have an elongation after fracture which meets the latter requirement and five or si
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.