SIST 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)
This part of ISO 10139 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 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.
Art 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
SIST EN ISO 10139-2:2016
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
SIST EN ISO 10139-2:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10139-2:2016
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SIST EN ISO 10139-2:2016
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.
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SIST EN ISO 10139-2:2016
EN ISO 10139-2:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10139-2:2016
EN ISO 10139-2:2016 (E)
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.
3
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SIST EN ISO 10139-2:2016
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SIST EN ISO 10139-2:2016
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
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SIST EN ISO 10139-2:2016
ISO 10139-2:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 10139-2:2016
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 2016 – All rights reserved iii
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SIST EN ISO 10139-2:2016
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 in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This third edition cancels and replaces the second edition (ISO 10139-2:2009), of which it constitutes a
minor revision to harmonize the definition of long-term use with other international definitions (30 days).
ISO 10139 consists of the following parts, under the general title Dentistry — Soft lining materials for
removable dentures:
— Part 1: Materials for short-term use
— Part 2: Materials for long-term use
iv © ISO 2016 – All rights reserved
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SIST EN ISO 10139-2:2016
ISO 10139-2:2016(E)
Introduction
Denture lining materials for long-term use are classified in this part of ISO 10139 according to their
softness. Although it is not claimed that any particular level of softness is superior to another, this
classification is intended to assist clinicians because clinicians will have more information with which
to make an informed choice.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this part of ISO 10139. Information relevant to assessing possible biological or toxicological hazards
is given in ISO 7405 and ISO 10993-1.
© ISO 2016 – All rights reserved v
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SIST EN ISO 10139-2:2016
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SIST EN ISO 10139-2:2016
INTERNATIONAL STANDARD ISO 10139-2:2016(E)
Dentistry — Soft lining materials for removable
dentures —
Part 2:
Materials for long-term use
1 Scope
This part of ISO 10139 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.
2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this document
and are indispensable for its application. 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, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1:
Durometer method (Shore hardness)
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 20795-1, Dentistry — Base polymers — Part 1: Denture base polymers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
soft denture lining material
soft resilient material bonded to the fitting surface of a denture to reduce trauma to the supporting tissues
3.2
long-term use
use for a period of more than 30 d
3.3
immediate container
container that is in direct contact with the material
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SIST EN ISO 10139-2:2016
ISO 10139-2:2016(E)
4 Classification
Soft lining materials for long-term use are classified into the following types according to Shore A
hardness of 24 h specimens (5.1) as determined in accordance with 7.2:
— Type A: soft;
— Type B: extra soft.
5 Requirements
5.1 Shore A hardness, 24 h
When 24 h test specimens are subjected to a 5 s Shore A hardness test in accordance with 7.2.3.2, the
material shall conform to the requirements for the relevant type as shown in Table 1. For a material to
be classified as a particular type, the mean Shore A hardness for at least two of the three specimens
shall conform to the requirements for that type, as specified in Table 1. If the results for two or more
specimens are greater than 50, the material shall be deemed not to conform to this par
...
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