Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)

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 10477:2020)

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 polymerbasierte dentale 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 10477:2020)

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, telle que les billes ou les fils.

Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)

General Information

Status
Published
Publication Date
03-Nov-2020
Withdrawal Date
30-May-2021
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
04-Nov-2020
Completion Date
04-Nov-2020

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SLOVENSKI STANDARD
01-december-2020
Nadomešča:
SIST EN ISO 10477:2018
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2020)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO 10477:2020)
Ta slovenski standard je istoveten z: EN ISO 10477:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10477
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10477:2018
English Version
Dentistry - Polymer-based crown and veneering materials
(ISO 10477:2020)
Médecine bucco-dentaire - Produits à base de Zahnheilkunde - Polymerbasierte Kronen- und
polymères pour couronnes et facettes (ISO Verblendwerkstoffe (ISO 10477:2020)
10477:2020)
This European Standard was approved by CEN on 12 September 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10477:2020) 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
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 10477:2018.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10477:2020 has been approved by CEN as EN ISO 10477:2020 without any modification.

INTERNATIONAL ISO
STANDARD 10477
Fourth edition
2020-10
Dentistry — Polymer-based crown and
veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Reference number
ISO 10477:2020(E)
©
ISO 2020
ISO 10477:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 10477:2020(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 .11
7.6.3
...

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