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

Status
Withdrawn
Publication Date
30-Oct-2016
Withdrawal Date
30-Jan-2017
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Jul-2016
Completion Date
20-Jul-2016

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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

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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.
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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.
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
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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
© ISO 2016 – All rights reserved 1
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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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