EN ISO 10477:2018
(Main)Dentistry - Polymer-based crown and veneering materials (ISO 10477:2018)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2018)
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2018)
Dieses Dokument beschreibt die Einteilung von polymerbasierten Kronen und Verblendwerkstoffen, die in der Zahnheilkunde verwendet werden, und legt ihre Anforderungen fest. Ebenso beschreibt es die Prüfverfahren, die zur Beurteilung der Konformität mit diesen Anforderungen verwendet werden.
Dieses Dokument gilt für polymerbasierte Kronen und Verblendwerkstoffe für im Labor hergestellte dauerhafte Verblendschalen oder Kronen. Es gilt ebenfalls für dentale polymerbasierte Kronen und Verblendwerkstoffe, für die der Hersteller angibt, dass sie an der Gerüststruktur ohne makro mechanische Retentionen, wie Perlen oder Drähte, haften.
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes (ISO 10477:2018)
Le présent document établit une classification des produits à base de polymères pour couronnes et facettes utilisés en médecine bucco-dentaire, et spécifie les exigences qui leur sont applicables. Il spécifie également les méthodes d'essai à utiliser en vue de la détermination de leur conformité à ces exigences.
Le présent document est applicable aux produits à base de polymères pour couronnes et facettes destinés aux couronnes ou facettes permanentes fabriquées en laboratoire. Il s'applique également aux produits à base de polymères pour couronnes et facettes pour lesquels le fabricant revendique une adhérence à l'infrastructure sans rétention macromécanique, tels que les billes ou les fils.
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2018)
Ta dokument razvršča polimerne materiale za prevleke in mostičke, ki se uporabljajo v zobozdravstvu, ter določa
zahteve v zvezi z njimi. Določa tudi preskusne metode, ki jih je treba uporabiti za ugotavljanje skladnosti s temi zahtevami.
Ta dokument se uporablja za polimerne materiale za prevleke in mostičke, in sicer za stalne mostičke ali prevleke, izdelane v laboratoriju. Uporablja se tudi za polimerne materiale za zobne prevleke in mostičke, za katere proizvajalec zagotavlja adhezijo na podstrukturo brez makro mehanske pritrditve, na primer s kroglicami ali žicami.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
1DGRPHãþD
SIST EN ISO 10477:2005
=RER]GUDYVWYR3ROLPHUQLPDWHULDOL]DSUHYOHNHLQPRVWLþNH ,62
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2018)
Zahnheilkunde - Kronen- und Verblendkunststoffe (ISO 10477:2018)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO 10477:2018)
Ta slovenski standard je istoveten z: EN ISO 10477:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10477
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10477:2004
English Version
Dentistry - Polymer-based crown and veneering materials
(ISO 10477:2018)
Médecine bucco-dentaire - Produits à base de Zahnheilkunde - Kronen- und Verblendkunststoffe (ISO
polymères pour couronnes et facettes (ISO 10477:2018)
10477:2018)
This European Standard was approved by CEN on 13 May 2018.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10477:2018) has been prepared by Technical Committee ISO/TC 106
“Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10477:2004.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10477:2018 has been approved by CEN as EN ISO 10477:2018 without any modification.
INTERNATIONAL ISO
STANDARD 10477
Third edition
2018-06
Dentistry — Polymer-based crown and
veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Reference number
ISO 10477:2018(E)
©
ISO 2018
ISO 10477:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2018 – All rights reserved
ISO 10477:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.2 Depth of cure . 3
5.2.1 General. 3
5.2.2 Depth of cure, Type 2, Class 2 materials . 3
5.3 Surface finish . 3
5.4 Flexural strength . 3
5.5 Bond strength. 4
5.5.1 Special bonding system without macromechanical retention . 4
5.5.2 Values higher than 5 MPa . 4
5.6 Water sorption . 4
5.7 Solubility . 4
5.8 Shade consistency . 4
5.9 Colour stability . 4
5.10 Biocompatibility . 4
6 Sampling . 4
6.1 For all tests . 4
6.2 For test of shade consistency . 5
6.3 For test of colour stability . 5
7 Measurement and test methods . 5
7.1 General . 5
7.1.1 Test conditions. 5
7.1.2 Water . 5
7.1.3 Preparation of test specimens . 5
7.2 Visual inspection . 5
7.3 Depth of cure . 5
7.3.1 Apparatus . 5
7.3.2 Materials . 6
7.3.3 Procedure . 6
7.3.4 Expression of results . 6
7.4 Surface finish . 6
7.5 Flexural strength . 7
7.5.1 Apparatus . 7
7.5.2 Materials . 8
7.5.3 Preparation of test specimens . 8
7.5.4 Procedure . 9
7.5.5 Expression of results . 9
7.6 Bond strength.10
7.6.1 Apparatus .10
7.6.2 Materials .
...
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