EN ISO 10139-2:2016
(Main)Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
ISO 10139-2:2016 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 2: Werkstoffe für die Langzeitanwendung (ISO/FDIS 10139-2:2016)
Dieser Teil von ISO 10139 legt Anforderungen an die Weichheit, Haftfestigkeit, Wasseraufnahme und Wasserlöslichkeit ebenso wie an die Verpackung, Kennzeichnung und Gebrauchsanweisung für weich-bleibende Unterfütterungswerkstoffe für Prothesen fest, die für Langzeitanwendungen geeignet sind. Diese Werkstoffe dürfen auch für maxillofaziale Prothesen verwendet werden.
Médecine bucco-dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 2: Produits pour usage à long terme (ISO 10139-2:2016)
L'ISO 10139-2 :2016 spécifie les exigences afférentes à la souplesse, à l'adhésion, à la sorption d'eau et à la solubilité dans l'eau des produits souples pour intrados de prothèses dentaires adaptés à un usage à long terme. Elle traite également des exigences relatives à leur conditionnement, à leur marquage et à leur mode d'emploi. Ces produits peuvent également être utilisés pour les prothèses maxillo-faciales.
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 2. del: Materiali za dolgoročno uporabo (ISO 10139-2:2016)
Ta del standarda ISO 10139 določa zahteve za mehkost, vezavo, absorpcijo vode in topnost
v vodi, kot tudi za embalažo, označevanje in navodila proizvajalca za mehke materiale za prevleko
zobnih protez za dolgoročno uporabo. Ti materiali se lahko uporabljajo tudi za maksilofacialne proteze.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2016
1DGRPHãþD
SIST EN ISO 10139-2:2009
=RER]GUDYVWYR0HKNLPDWHULDOL]DSUHYOHNRVQHPQLK]REQLKSURWH]GHO
0DWHULDOL]DGROJRURþQRXSRUDER ,62
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term
use (ISO 10139-2:2016)
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 2:
Werkstoffe für die Langzeitanwendung (ISO 10139-2:2016)
Art dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 2:
Produits pour usage à long terme (ISO 10139-2:2016)
Ta slovenski standard je istoveten z: EN ISO 10139-2:2016
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10139-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2016
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10139-2:2009
English Version
Dentistry - Soft lining materials for removable dentures -
Part 2: Materials for long-term use (ISO 10139-2:2016)
Médecine bucco-dentaire - Produits souples pour Zahnheilkunde - Weichbleibende
intrados de prothèses dentaires amovibles - Partie 2: Unterfütterungswerkstoffe für Prothesen - Teil 2:
Produits pour usage à long terme (ISO 10139-2:2016) Werkstoffe für die Langzeitanwendung (ISO/FDIS
10139-2:2016)
This European Standard was approved by CEN on 12 May 2016.
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, 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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10139-2:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10139-2:2016) 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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 2017.
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 10139-2:2009.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10139-2:2016 has been approved by CEN as EN ISO 10139-2:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 10139-2
Third edition
2016-06-15
Dentistry — Soft lining materials for
removable dentures —
Part 2:
Materials for long-term use
Médecine bucco-dentaire — Produits souples pour intrados de
prothèses dentaires amovibles —
Partie 2: Produits pour usage à long terme
Reference number
ISO 10139-2:2016(E)
©
ISO 2016
ISO 10139-2:2016(E)
© ISO 2016, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 10139-2:2016(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 Shore A hardness, 24 h . 2
5.2 Shore A hardness, 30 d . 2
5.3 Bond strength. 2
5.4 Sorption . 2
5.5 Solubility . 2
6 Sampling . 3
7 Test methods . 3
7.1 Test conditions . 3
7.2 Shore A hardness . 3
7.2.1 Apparatus . 3
7.2.2 Preparation of test samples . 3
7.2.3 Procedure . 3
7.2.4 Expression of results . 4
7.3 Bond strength. 4
7.3.1 Materials . 4
7.3.2 Preparation of acrylic denture base plates . 4
7.3.3 Preparation of test specimens . 5
7.3.4 Procedure for tensile testing . 5
7.4 Water sorption and solubility . 6
7.4.1 Materials . 6
7.4.2 Apparatus . 7
7.4.3 Preparation of test specimens . 8
7.4.4 Procedure . 8
7.4.5 Calculation and expression of results . 9
8 Requirements for packaging, marking and instructions supplied by manufacturer .9
8.1 Packaging . 9
8.2 Marking . 9
8.3 Manufacturer’s instructions for use .10
Bibliography .12
ISO 10139-2:2016(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 i
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.