EN ISO 22674:2016

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
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 21-Sep-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 22674:2016 - Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)

Relations

• Replaces: EN ISO 22674:2006 - Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2006)
• Effective Date: 15-Feb-2012
• Replaced By: EN ISO 22674:2022 - Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2022)
• Effective Date: 28-Sep-2022

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.
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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
...