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
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
19-Jun-2019
Completion Date
19-Jun-2019

RELATIONS

Buy Standard

Standard
EN ISO 4049:2019
English language
38 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 4049:2019
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
SIST EN ISO 4049:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 4049:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 4049:2019
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 4049:2019
EN ISO 4049:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 4049:2019
EN ISO 4049:2019 (E)
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 4049:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 4049:2019
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
---------------------- Page: 7 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 4049:2019
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 ............................................................................................................................................................................14

© ISO 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(E)

7.9.2 Procedure ............................................................................................................................................................................14

7.9.3 Treatment of results...................................................................................................................................................15

7.10 Depth of cure, Class 2 materials excluding luting materials .........................................................................15

7.10.1 Apparatus ............................................................................................................................................................................15

7.10.2 Procedure ............................................................................................................................................................................15

7.10.3 Treatment of results...................................................................................................................................................16

7.11 Flexural strength ................................................................................................................................................................................16

7.11.1 Apparatus ............................................................................................................................................................................16

7.11.2 Preparation of test specimens ...........................................................................................................................17

7.11.3 Procedure ............................................................................................................................................................................18

7.11.4 Treatment of results...................................................................................................................................................18

7.12 Water sorption and solubility .................................................................................................................................................19

7.12.1 Apparatus ............................................................................................................................................................................19

7.12.2 Preparation of test specimens ...........................................................................................................................20

7.12.3 Procedure ............................................................................................................................................................................21

7.12.4 Treatment of results...................................................................................................................................................21

7.13 Shade and colour stability after irradiation and water sorption ..............................................................22

7.13.1 General...................................................................................................................................................................................22

7.13.2 Apparatus ............................................................................................................................................................................22

7.13.3 Preparation of test specimens ...........................................................................................................................23

7.13.4 Procedure ............................................................................................................................................................................23

7.13.5 Colour comparison for shade .............................................................................................................................23

7.13.6 Colour comparison for colour stability .....................................................................................................23

7.14 Radio-opacity ........................................................................................................................................................................................23

7.14.1 Perform the test in accordance with ISO 13116 ................................................................................23

7.14.2 Preparation of test specimens ...........................................................................................................................23

7.14.3 Treatment of results...................................................................................................................................................23

8 Packaging, marking, instructions and information to be supplied by the manufacturer .....24

8.1 Packaging ..................................................................................................................................................................................................24

8.2 Marking and instructions for use .........................................................................................................................................24

8.3 Declaration of components .......................................................................................................................................................28

Bibliography .............................................................................................................................................................................................................................29

iv © ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling

and restorative materials.

This fifth edition cancels and replaces the fourth edition (ISO 4049:2009), which has been technically

revised. The main changes compared to the previous edition are as follows:

— the test for sensitivity to ambient light has been changed because a filter used in the current test

was not available;
— the test for radio-opacity has been updated to refer to ISO 13116;

— luting materials no longer have to conform to the requirement for depth of cure;

— the manufacturer is now required to publish details of material composition, see Clause 8;

— several minor changes have been made to clarify content together with editorial changes.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(E)
Introduction

Specific qualitative and quantitative requirements for freedom from biological hazard are not included

in this document. It is recommended, however, that reference should be made to ISO 10993-1 and

ISO 7405 when assessing possible biological or toxicological hazards.
vi © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 4049:2019
INTERNATIONAL STANDARD ISO 4049:2019(E)
Dentistry — Polymer-based restorative materials
1 Scope

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).
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 3696:1987, Water for analytical laboratory use — Specification and test methods

ISO 7491:2000, Dental materials — Determination of colour stability

ISO 8601-1:2019, Date and time —Representations for information interchange Part — 1: Basic rules

ISO 8601-2:2019, Date and time —Representations for information interchange Part — 2: Extensions

ISO 13116:2014, Dentistry — Test method for determining radio-opacity of materials

ISO 17304:2013, Dentistry — Polymerization shrinkage: Method for determination of polymerization

shrinkage of polymer-based materials
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
opaque

shade of an intensely pigmented polymer-based restorative material of low translucency

3.2
outer pack
form of packaging used to combine a number of single dose containers or capsules
© ISO 2019 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(E)
3.3
outermost packaging

form of packaging used to combine material and additional items, including instructions for use and

any proportioning or mixing devices, that are supplied with the material
3.4
container
capsule
primary packaging of the material
4 Classification
4.1 Type

For the purposes of this document, dental polymer-based restorative materials are classified into the

following types.

— Type 1: Polymer-based restorative materials claimed by the manufacturer as suitable for

restorations involving occlusal surfaces;
— Type 2: All other polymer-based restorative materials, and luting materials.
4.2 Class
The three classes of dental polymer-based restorative materials are as follows:

— Class 1: Materials whose setting is effected by mixing an initiator and activator (“Self-curing”

materials).

— Class 2: Materials whose setting is effected by the application of energy from an external source,

such as blue light or heat, (“external-energy-activated” materials, see also Table 4, items 9 and 20).

They are subdivided as follows:
1) Group 1: Materials whose use requires the energy to be applied intra-orally;

2) Group 2: Materials whose use requires the energy to be applied extra-orally. When fabricated,

these materials will be luted into place.

Certain materials may be claimed by manufacturers to be both Group 1 and Group 2. In this event

the material shall fulfil the requirements for both groups.
NOTE Class 2 luting materials fall into Group 1 only.

— Class 3: Materials that are cured by the application of external energy, and also have a self-curing

mechanism present (“dual-cure” materials).
5 Requirements
5.1 Biocompatibility
For guidance on biocompatibility see ISO 7405 and ISO 10993-1.
5.2 Physical and chemical properties
5.2.1 General

If a restorative material is supplied by the manufacturer in various shades, each shade, including opaque

shades, shall be capable of satisfying all the requirements for sensitivity to the dental operating light

2 © ISO 2019 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 4049:2019
ISO 4049:2019(E)

(5.2.7), depth of cure (5.2.8), shade (5.3) and colour stability (5.4) appropriate to the material type and

class. If the material is supplied such that it can be “tinted” or “blended” to the user’s prescription, the

material shall conform to the requirements both when used alone and when used with the maximum

recommended proportion of tint or blender (see Table 4, item 19). Depth of cure (5.2.8) of luting

materials shall not be tested.

Colour stability (5.4) of luting materials shall not be tested unless the manufacturer claims such a

property.

In respect of the other requirements of 5.2 and those of 5.5, only one representative shade of restorative

materials shall be tested. This representative shade shall be either that classified by the manufacturer

as “Universal” or, in the event that no shade is so classifi
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.