EN ISO 4049:2019

Dentistry - Polymer-based restorative materials (ISO 4049:2019)

This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

Zahnheilkunde - Polymerbasierende Restaurationswerkstoffe (ISO 4049:2019)

Dieses Dokument legt Anforderungen an zahnärztliche polymerbasierende Restaurations¬werkstoffe fest, die in geeigneter Form zum mechanischen Mischen, Handmischen oder zur intraoralen und extraoralen äußeren Energieaktivierung vorgesehen sind und die hauptsächlich für direkte oder indirekte Restaurationen der Zähne und für Befestigungen vorgesehen sind.
Die polymerbasierenden Befestigungswerkstoffe, die in diesem Dokument beschrieben werden, sind für die Zementierung oder Befestigung von Restaurationen und Anwendungen wie Inlays, Onlays, Verblendungen, Kronen und Brücken vorgesehen. Dieses Dokument gilt nicht für polymerbasierende Befestigungswerkstoffe, die eine adhäsive Komponente in der Struktur des Werkstoffes aufweisen (siehe ISO/TS 16506).
Dieses Dokument ist nicht anwendbar für polymerbasierende Werkstoffe, die zur Kariesprophylaxe (siehe ISO 6874), als Kernwerkstoffe oder zur indirekten Verblendung von Metallgerüsten (siehe ISO 10477) vorgesehen sind.

Médecine bucco-dentaire - Produits de restauration à base de polymères (ISO 4049:2019)

Le présent document spécifie les exigences relatives aux produits dentaires de restauration à base de polymères fournis sous une forme convenant pour le mélange mécanique, manuel, ou à polymérisation intrabuccale et extrabuccale par énergie externe, et prévus en premier lieu pour être utilisés pour des restaurations directes ou indirectes des dents et pour des scellements.
Les produits de scellement à base de polymères couverts par le présent document sont prévus pour une utilisation dans le collage ou la fixation de restaurations et de dispositifs tels que les inlays, onlays, facettes, couronnes et ponts (bridges). Le présent document ne couvre pas les produits de scellement à base de polymères qui contiennent un composant adhésif dans la structure du produit (voir l'ISO/TS 16506).
Il ne traite pas des produits à base de polymères destinés à la prévention des caries (voir l'ISO 6874), des produits pour masse ou de ceux utilisés pour le revêtement des bases en métal (voir l'ISO 10477).

Zobozdravstvo - Materiali za obnovo zob na osnovi polimerov (ISO 4049:2019)

Ta dokument določa zahteve za materiale za obnovo zob na osnovi polimerov, ki so na voljo v obliki, primerni za mehansko mešanje, ročno mešanje ali za intra- ali ekstraoralno aktivacijo z zunanjo energijo, ter namenjene predvsem neposredni ali posredni obnovi zob oz. za tesnjenje. Materiali za tesnjenje na osnovi polimerov, zajeti v tem dokumentu, so namenjeni uporabi pri cementiranju ali pritrditvi obnov in pripomočkov, kot so indirektne zalivke (inlay, onlay), prevleke, krone in mostički. Ta dokument ne zajema materialov za tesnjenje na osnovi polimerov, ki imajo v strukturi materiala lepilno komponento (glej ISO/TS 16506).
Dokument ne zajema materialov na osnovi polimerov, namenjenih preprečevanju zobne gnilobe (glej ISO 6874), osnovnih materialov ali materialov, ki se uporabljajo za prekrivanje kovinskih pomožnih okvirov (glej ISO 10477).

General Information

• Status: Published
• Publication Date: 18-Jun-2019
• Withdrawal Date: 30-Dec-2019
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Jun-2019
• Completion Date: 19-Jun-2019
• Ref Project: SIST EN ISO 4049:2019 - Dentistry - Polymer-based restorative materials (ISO 4049:2019)

Relations

• Replaces: EN ISO 4049:2009 - Dentistry - Polymer-based restorative materials (ISO 4049:2009)
• Effective Date: 13-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 4049:2010
Zobozdravstvo - Materiali za obnovo zob na osnovi polimerov (ISO 4049:2019)
Dentistry - Polymer-based restorative materials (ISO 4049:2019)
Zahnheilkunde - Polymerbasierende Restaurationswerkstoffe (ISO 4049:2019)
Art dentaire - Produits de restauration à base de polymères (ISO 4049:2019)
Ta slovenski standard je istoveten z: EN ISO 4049:2019
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 4049
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2019
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 4049:2009
English Version
Dentistry - Polymer-based restorative materials (ISO
4049:2019)
Médecine bucco-dentaire - Produits de restauration à Zahnheilkunde - Polymerbasierende
base de polymères (ISO 4049:2019) Restaurationswerkstoffe (ISO 4049:2019)
This European Standard was approved by CEN on 18 May 2019.

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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4049:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 4049:2019) 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 December 2019, and conflicting national standards
shall be withdrawn at the latest by December 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 4049:2009.
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 4049:2019 has been approved by CEN as EN ISO 4049:2019 without any modification.

INTERNATIONAL ISO
STANDARD 4049
Fifth edition
2019-05
Dentistry — Polymer-based
restorative materials
Médecine bucco-dentaire — Produits de restauration à base de
polymères
Reference number
ISO 4049:2019(E)
©
ISO 2019
ISO 4049:2019(E)
© ISO 2019
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 4049:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Type . 2
4.2 Class . 2
5 Requirements . 2
5.1 Biocompatibility . 2
5.2 Physical and chemical properties . 2
5.2.1 General. 2
5.2.2 Film thickness, luting materials . 3
5.2.3 Working time, Class 1 and Class 3 restorative materials, excluding luting
materials . 3
5.2.4 Working time, Class 1 and Class 3 luting materials . 3
5.2.5 Setting time, Class 1 materials . 3
5.2.6 Setting time, Class 3 materials . 3
5.2.7 Sensitivity to light, Class 2 materials . 3
5.2.8 Depth of cure, Class 2 materials excluding luting materials . 3
5.2.9 Flexural strength . 4
5.2.10 Water sorption and solubility . 4
5.3 Shade of restorative materials . 4
5.4 Colour stability after irradiation and water sorption . 4
5.5 Radio-opacity . 4
6 Sampling . 5
7 Test methods . 5
7.1 General reagent — Water . 5
7.2 Test conditions . 5
7.3 Inspection . 6
7.4 Preparation of test specimens . 6
7.5 Measurement of film thickness of luting materials . 6
7.5.1 Apparatus . 6
7.5.2 Test procedure . 8
7.5.3 Treatment of results. 9
7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials .10
7.6.1 Apparatus .10
7.6.2 Procedure .11
7.6.3 Treatment of results.11
7.7 Working time, Class 1 and Class 3 luting materials .12
7.7.1 Apparatus .12
7.7.2 Procedure .12
7.7.3 Treatment of results.12
7.8 Setting time, Class 1 and Class 3 materials .12
7.8.1 Apparatus for the determination of setting time of Class 1 and Class 3
restorative materials .12
7.8.2 Apparatus for the determination of setting time of Class 1 and Class 3
luting materials .12
7.8.3 Procedure .12
7.8.4 Treatment of results.13
7.9 Sensitivity to light, Class 2 materials .13
7.9.1 Apparatus .
...