EN ISO 9917-2:2017

Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017)

ISO 9917-2:2017 specifies requirements and test methods for water-based dental cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes.
EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization.
NOTE   The attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917‑1 so that they can consider which is the most appropriate for evaluating any individual product.

Zahnheilkunde - Wasserhärtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO 9917-2:2017)

Dieses Dokument legt Anforderungen und Prüfverfahren für zahnärztliche Zemente auf Wasserbasis fest, bei denen die Aushärtung durch die Kombination einer Säure-Base-Reaktion mit einer Polymerisation erfolgt. Die Werkstoffe werden für Befestigungen, Basen oder Unterfüllungen, Füllungen und Zahnstumpfaufbauten verwendet.
BEISPIEL   Konventionelle Glas-Polyalkenoat-Zemente werden im Allgemeinen durch die Reaktion von herauslösbaren Ionen aus Aluminiumsilikatglas mit einer polyalkenhaltigen Säure in einer wässrigen Umgebung hergestellt. Bei den Materialien, die in den Anwendungsbereich dieses Dokumentes fallen, erfolgt die Aushärtung üblicherweise durch solch eine wässrige Säure-Base-Reaktion, zusätzlich erfolgt jedoch eine Abbindung durch Polymerisation.
ANMERKUNG   Für Hersteller und Prüfinstitute wird auf die eng mit dieser Norm verbundenen Internationalen Normen ISO 4049 und ISO 9917-1 hingewiesen. Für die Bewertung eines einzelnen Produktes sollte die Internationale Norm verwendet werden, die dafür am besten geeignet ist.

Médecine bucco-dentaire - Ciments à base d'eau - Partie 2: Ciments modifiés par addition de résine (ISO 9917-2:2017)

ISO 9917-2:2017 spécifie des exigences et des méthodes d'essai relatives aux ciments dentaires à base d'eau dans lesquels la prise est obtenue par l'association d'une réaction acido-basique et d'une polymérisation. Les produits sont destinés à être utilisés pour scellement, fond de cavité ou base, restauration et faux moignon.
EXEMPLE       Les ciments traditionnels au polyalkénoate de verre sont généralement formés par réaction d'un verre aluminosilicate libérant des ions en présence d'un acide polyalkénoïde dans un milieu aqueux. Les produits relevant du domaine d'application du présent document seront généralement susceptibles de provoquer la prise par une réaction de type acido-basique en milieu aqueux, mais pourront en outre faire l'objet d'une prise par réaction de polymérisation.
NOTE       L'attention des fabricants et des laboratoires d'essai est attirée sur les Normes internationales ISO 4049 et ISO 9917‑1 étroitement liées pour qu'ils puissent examiner laquelle est la plus appropriée afin d'évaluer chaque produit individuel.

Zobozdravstvo - Cementi na vodni osnovi - 2. del: Cementi z vsebnostjo smole (ISO 9917-2:2017)

Ta dokument določa zahteve in preskusne metode za zobne cemente na vodni osnovi, ki se strdijo zaradi kombinacije kislinske reakcije in polimerizacije. Materiali se
uporabljajo kot tesnilo, osnova ali prevleka oziroma za obnovo ali izgradnjo jedra zoba.
PRIMER: Običajni cementi iz steklenega polialkenoata se običajno strdijo z reakcijo aluminosilikatnega stekla, ki izločuje ione, s polialkenojsko kislino v vodnem okolju. Materiali, ki spadajo na področje uporabe
tega dokumenta, se običajno lahko strdijo na podlagi take vodne kislinske reakcije, vendar se lahko strdijo tudi na podlagi polimerizacije.
OPOMBA: Za proizvajalce in preskusne laboratorije sta izpostavljena sorodna mednarodna
standarda ISO 4049 in ISO 9917-1, tako da se lahko sami odločijo, kateri je primernejši za ocenjevanje posameznih izdelkov.

General Information

• Status: Published
• Publication Date: 19-Sep-2017
• Withdrawal Date: 30-Mar-2018
• 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: 20-Sep-2017
• Completion Date: 20-Sep-2017
• Ref Project: SIST EN ISO 9917-2:2017 - Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017)

Relations

• Replaces: EN ISO 9917-2:2010 - Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2010)
• Effective Date: 27-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 9917-2:2010
Zobozdravstvo - Cementi na vodni osnovi - 2. del: Cementi z vsebnostjo smole
(ISO 9917-2:2017)
Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017)
Zahnheilkunde - Wasserhärtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO
9917-2:2017)
Médecine bucco-dentaire - Ciments à base d'eau - Partie 2: Ciments modifiés par
addition de résine (ISO 9917-2:2017)
Ta slovenski standard je istoveten z: EN ISO 9917-2:2017
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 9917-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 9917-2:2010
English Version
Dentistry - Water-based cements - Part 2: Resin-modified
cements (ISO 9917-2:2017)
Médecine bucco-dentaire - Ciments à base d'eau - Zahnheilkunde - Wasserhärtende Zemente - Teil 2:
Partie 2: Ciments modifiés par addition de résine (ISO Kunststoffmodifizierte Zemente (ISO 9917-2:2017)
9917-2:2017)
This European Standard was approved by CEN on 1 July 2017.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-2:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 9917-2:2017) 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 March 2018 and conflicting national standards shall be
withdrawn at the latest by March 2018.
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 9917-2:2010.
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 9917-2:2017 has been approved by CEN as EN ISO 9917-2:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 9917-2
Third edition
2017-09
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
Médecine bucco-dentaire — Ciments à base d’eau —
Partie 2: Ciments modifiés par addition de résine
Reference number
ISO 9917-2:2017(E)
©
ISO 2017
ISO 9917-2:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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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Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification and applications . 2
4.1 Classification . 2
4.2 Applications . 2
5 Requirements . 3
5.1 Materials . 3
5.2 Working time . 3
5.3 Setting time — Class 1 and Class 3 materials only . 3
5.4 Film thickness — Luting materials only (see 4.2) . 3
5.5 Flexural strength . 3
5.6 Radio-opacity . 3
5.7 Shade and colour stability — Restorative materials only . 3
6 Sampling . 3
7 Test conditions and preparation of test specimens . 4
7.1 Test conditions . 4
7.2 Method of mixing . 4
7.3 Inspection . 4
8 Packaging, marking and information to be supplied by the manufacturer .4
8.1 Packaging . 4
8.2 Marking and instructions for use . 5
Annex A (normative) Determination of working time and setting time . 8
Annex B (normative) Determination of film thickness — Luting materials only .10
Annex C (normative) Determination of flexural strength .12
Annex D (normative) Determination of radio-opacity .17
Annex E (normative) Determination of shade and colour stability — Restorative (except for
tooth core build-up) and luting materials only .19
Bibliography .21
ISO 9917-2:2017(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: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and restorative materials.
This third edition cancels and replaces the second edition (ISO 9917-2:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the adoption of ISO 13116 as the measuring procedure of the test method for radio-opacity;
— the inclusion of tooth core build-up as a restoration in the scope;
— the adoption of other minor technical revisions in the test methods.
A list of all parts of the ISO 9917 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
Introduction
This document has been prepared in order to present the requirements and test methods for cements
in which setting is achieved by a combination of an acid-base reaction and polymerization. The
polymerization component of the reaction may be activated by mixing different components or through
application of energy from an external source. As
...