EN ISO 4049:2009
(Main)Dentistry - Polymer-based restorative materials (ISO 4049:2009)
Dentistry - Polymer-based restorative materials (ISO 4049:2009)
ISO 4049:2009 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 cavities in the teeth and for luting.
The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This International Standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material.
Zahnheilkunde - Polymerbasierende Restaurationsmaterialien (ISO 4049:2009)
Diese Internationale Norm legt Anforderungen an zahnärztliche polymerbasierende Restaurationsmaterialien fest, die in geeigneter Form zum mechanischen Mischen, Handmischen oder zur intraoralen und extraoralen Aktivierung durch Bestrahlung vorgesehen sind und die hauptsächlich für direkte oder indirekte Restau-rationen von Zahnkavitäten und für Befestigungen vorgesehen sind.
Die in dieser Norm eingeschlossenen Befestigungskunststoffe sind für die Zementierung oder Befestigung von Restaurationen und Anwendungen wie Inlays, Onlays, Verblendungen, Kronen und Brücken vorgesehen. Diese Internationale Norm gilt nicht für Befestigungskunststoffe, die einen adhäsiven Anteil in der Struktur des Werkstoffes aufweisen.
Diese Norm ist nicht anwendbar für Materialien, die zur Kariesprophylaxe (siehe ISO 6874) oder zur indirekten Verblendung von Metallgerüsten (siehe ISO 10477) vorgesehen sind.
Art dentaire - Produits de restauration à base de polymères (ISO 4049:2009)
L'ISO 4049:2009 spécifie des exigences pour les 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 dans les cavités de dents et pour des scellements.
Les produits de scellement à base de polymères couverts par l'ISO 4049:2009 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). La présente Norme internationale ne couvre pas les produits de scellement à base de polymères qui ont un composant adhésif dans la structure du produit.
Zobozdravstvo - Restavrativni materiali na osnovi polimerov (ISO 4049:2009)
Ta mednarodni standard določa zahteve za zobozdravstvene restavrativne materiale na osnovi polimerov, ki so na voljo v obliki, primerni za mehansko mešanje, ročno mešanje ali za intra- ali ekstraoralno aktivacijo z zunanjo energijo in se uporabljajo predvsem za neposredno ali posredno obnovitev luknjic v zobeh ter kot tesnilo. Tesnilni materiali na osnovi polimerov, za katere velja ta mednarodni standard, so namenjeni uporabi pri cementiranju ali pritrjevanju obnov in dodatkov, kot so inleji, onleji, prevleke, krone in mostički. Ta mednarodni standard ne vključuje tesnilnih materialov na osnovi polimera, ki imajo znotraj strukture materiala adhezivno sestavino. Ta mednarodni standard ne zajema materialov, ki so namenjeni preprečevanju zobne gnilobe (glej ISO 6874) ali ki se uporabljajo za prekrivanje kovinskih pomožnih okvirov (glej ISO 10477).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 4049:2000
Zobozdravstvo - Restavrativni materiali na osnovi polimerov (ISO 4049:2009)
Dentistry - Polymer-based restorative materials (ISO 4049:2009)
Zahnheilkunde - Restaurative Kunststoffe (ISO 4049:2009)
Art dentaire - Produits d'obturation, de restauration et de scellement à base de
polymères (ISO 4049:2009)
Ta slovenski standard je istoveten z: EN ISO 4049:2009
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 4049
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.060.10 Supersedes EN ISO 4049:2000
English Version
Dentistry - Polymer-based restorative materials (ISO 4049:2009)
Art dentaire - Produits de restauration à base de polymères Zahnheilkunde - Polymerbasierende
(ISO 4049:2009) Restaurationsmaterialien (ISO 4049:2009)
This European Standard was approved by CEN on 24 September 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4049:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 4049:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 2010.
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.
This document supersedes EN ISO 4049:2000.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 4049:2009 has been approved by CEN as a EN ISO 4049:2009 without any modification.
INTERNATIONAL ISO
STANDARD 4049
Fourth edition
2009-10-01
Dentistry — Polymer-based restorative
materials
Art dentaire — Produits de restauration à base de polymères
Reference number
ISO 4049:2009(E)
©
ISO 2009
ISO 4049:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 4049:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Classification .2
5 Requirements.2
5.1 Biocompatibility.2
5.2 Physical and chemical properties .2
5.3 Shade, 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.6
7.3 Inspection.6
7.4 Preparation of test specimens .6
7.5 Measurement of film thickness of luting materials.6
7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials.9
7.7 Working time, Class 1 and Class 3 luting materials .11
7.8 Setting time, Class 1 and Class 3 materials .11
7.9 Sensitivity to ambient light, Class 2 materials .13
7.10 Depth of cure, Class 2 materials.14
7.11 Flexural strength .15
7.12 Water sorption and solubility.18
7.13 Shade and colour stability after irradiation and water sorption.21
7.14 Radio-opacity.22
8 Packaging, marking and instructions and information to be supplied by the manufacturer.25
8.1 Packaging.25
8.2 Marking.25
8.3 Manufacturer’s instructions and information for the user.27
Bibliography.28
ISO 4049:2009(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 4049 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This fourth edition cancels and replaces the third edition (ISO 4049:2000) which has been reviewed and
essentially reconfirmed. Several minor changes have been made to clarify content. Changes have been made
to the test method for radio-opacity (see 7.14) in order to simplify this test.
iv © ISO 2009 – All rights reserved
ISO 4049:2009(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that when assessing possible biological or toxicological
hazards, reference should be made to ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 4049:2009(E)
Dentistry — Polymer-based restorative materials
1 Scope
This International Standard 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 cavities in the teeth and for luting.
The polymer-based luting materials covered by this International Standard are intended for use in the
cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
This International Standard does not cover those polymer-based luting materials that have an adhesive
component within the structure of the material.
This International Standard does not cover materials intended to prevent caries (see ISO 6874) or those used
for veneering metal sub-frames (see ISO 10477).
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 3665, Photography — Intra-oral dental radio
...
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