SIST EN ISO 10139-1:2018
(Main)Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)
This document specifies requirements for the physical properties, test methods, packaging, marking
and manufacturer's instructions for soft denture lining materials suitable for short-term use, including
functional impression taking using existing removable prosthesis.
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1: Werkstoffe für kurzzeitige Anwendungen (ISO 10139-1:2018)
Dieser Teil von ISO 10139 legt Anforderungen an die physikalischen Eigenschaften, Prüfverfahren, Verpackung, Kennzeichnung und Gebrauchsanweisungen für weichbleibende Unter¬fütterungswerkstoffe für Prothesen fest, die für eine Kurzzeitanwendung geeignet sind, einschließlich der Funktionsabformung unter Verwendung einer vorhandenen herausnehmbaren Prothese.
Médecine bucco-dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 1: Produits pour usage à court terme (ISO 10139-1:2018)
ISO 10139-1:2018 spécifie les exigences relatives aux propriétés physiques, aux méthodes d'essai, à l'emballage, au marquage et aux instructions du fabricant concernant les produits souples pour intrados de prothèses dentaires amovibles pour un usage à court terme, y compris la prise d'empreinte fonctionnelle réalisée à l'aide de prothèses dentaires amovibles existantes.
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 1. del: Materiali za kratkotrajno uporabo (ISO 10139-1:2018)
Ta dokument določa zahteve za fizikalne lastnosti, preskusne metode, pakiranje, označevanje in navodila proizvajalca mehkih materialov za prevleko zob, primernih za kratkotrajno uporabo, vključno z jemanjem funkcionalnega odtisa z uporabo obstoječih snemljivih protez.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10139-1:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 10139-1:2005
SIST EN ISO 10139-1:2005/AC:2006
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 1. del:
Materiali za kratkotrajno uporabo (ISO 10139-1:2018)
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term
use (ISO 10139-1:2018)
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1:
Werkstoffe für kurzzeitige Anwendungen (ISO 10139-1:2018)
Médecine bucco-dentaire - Produits souples pour intrados de prothèses dentaires
amovibles - Partie 1: Produits pour usage à court terme (ISO 10139-1:2018)
Ta slovenski standard je istoveten z: EN ISO 10139-1:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 10139-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 10139-1:2018
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SIST EN ISO 10139-1:2018
EN ISO 10139-1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10139-1:2005
English Version
Dentistry - Soft lining materials for removable dentures -
Part 1: Materials for short-term use (ISO 10139-1:2018)
Médecine bucco-dentaire - Produits souples pour Zahnheilkunde - Weichbleibende
intrados de prothèses dentaires amovibles - Partie 1: Unterfütterungswerkstoffe für Prothesen - Teil 1:
Produits pour usage à court terme (ISO 10139-1:2018) Werkstoffe für kurzzeitige Anwendungen (ISO 10139-
1:2018)
This European Standard was approved by CEN on 23 April 2018.
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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10139-1:2018 E
worldwide for CEN national Members.
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SIST EN ISO 10139-1:2018
EN ISO 10139-1:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10139-1:2018
EN ISO 10139-1:2018 (E)
European foreword
This document (EN ISO 10139-1:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 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 10139-1:2005.
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 10139-1:2018 has been approved by CEN as EN ISO 10139-1:2018 without any
modification.
3
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SIST EN ISO 10139-1:2018
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SIST EN ISO 10139-1:2018
INTERNATIONAL ISO
STANDARD 10139-1
Third edition
2018-03
Dentistry — Soft lining materials for
removable dentures —
Part 1:
Materials for short-term use
Médecine bucco-dentaire — Produits souples pour intrados de
prothèses dentaires amovibles —
Partie 1: Produits pour usage à court terme
Reference number
ISO 10139-1:2018(E)
©
ISO 2018
---------------------- Page: 7 ----------------------
SIST EN ISO 10139-1:2018
ISO 10139-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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 2018 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10139-1:2018
ISO 10139-1:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Types. 2
4.2 Classes . 2
5 Requirements . 2
5.1 Shore A0 hardness . 2
5.1.1 Shore A0 hardness at 2 h . 2
5.1.2 Shore A0 hardness at 7 d . 2
5.2 Consistency . 2
5.3 Detail reproduction . 3
6 Sampling . 3
7 Test methods . 3
7.1 Ambient conditions for testing . 3
7.2 Shore A0 hardness . 3
7.2.1 Apparatus . 3
7.2.2 Procedure . 3
7.3 Consistency test . 5
7.3.1 Test conditions. 5
7.3.2 Apparatus . 5
7.3.3 Test procedure . 5
7.4 Detail reproduction test . 5
7.4.1 General. 5
7.4.2 Apparatus . 5
7.4.3 Procedure . 6
8 Requirement for packaging, marking and instructions supplied by the manufacturer .8
8.1 Packaging . 8
8.2 Marking and manufacturer's instructions for use . 8
Bibliography .10
© ISO 2018 – All rights reserved iii
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SIST EN ISO 10139-1:2018
ISO 10139-1:2018(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 2,
Prosthodontic materials.
This third edition cancels and replaces the second edition (ISO 10139-1:2005), which has been
technically revised. It also incorporates the Technical Corrigendum ISO 10139-1:2005/Cor.1:2006.
A list of all parts in the ISO 10139 series can be found on the ISO website.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 10139-1:2018
ISO 10139-1:2018(E)
Introduction
Clinically, short-term denture-lining materials are used commonly as tissue conditioners and as
temporary soft lining materials. Furthermore, some materials are also indicated for functional
impression taking. Therefore, the tests are designed to cover the more common usages.
It is recognized that the short-term material, when used as a tissue conditioner, is commonly changed
every few days with the aim of returning the mucosa to a healthy condition as quickly as possible. As
a temporary soft lining, the material is commonly placed in immediate dentures and in dentures that
need to be modified as part of implant treatment. Therefore the specification has been so designed to
necessitate that a material exhibit the required properties over a 7 d period. It is of course recognized
that there are a number of clinical situations where it is appropriate to retain the soft lining in the
denture for periods longer than 7 d. It is also recognized that manufacturers may wish to provide
more than one set of times, temperatures, proportions and procedures to mix or prepare the material
properly in order that the material can satisfy the requirements of more than one type or class.
In an attempt to establish some degree of harmony with the procedures used to evaluate related
dental materials, the detail reproduction test has been adopted for materials also used for functional
impression taking (ISO 4823). As well, in this revision of the standard, the Shore A0 hardness test has
replaced the depth of penetration test, and the consistency test has been reintroduced as a replacement
of the elastic recovery test due to complexity of this method.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this document, but it is recommended that, for the assessment of
possible biologic
...
SLOVENSKI STANDARD
oSIST prEN ISO 10139-1:2017
01-september-2017
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 1. del:
Materiali za kratkotrajno uporabo (ISO/DIS 10139-1:2017)
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term
use (ISO/DIS 10139-1:2017)
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1:
Werkstoffe für kurzzeitige Anwendungen (ISO/DIS 10139-1:2017)
Médecine bucco-dentaire - Produits souples pour intrados de prothèses dentaires
amovibles - Partie 1: Produits pour usage à court terme (ISO/DIS 10139-1:2017)
Ta slovenski standard je istoveten z: prEN ISO 10139-1
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
oSIST prEN ISO 10139-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 10139-1:2017
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10139-1:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10139-1
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-05-16 2017-08-07
Dentistry — Soft lining materials for removable
dentures —
Part 1:
Materials for short-term use
Médecine bucco-dentaire — Produits souples pour intrados de prothèses dentaires amovibles —
Partie 1: Produits pour usage à court terme
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10139-1:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10139-1:2017
ISO/DIS 10139-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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 2017 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10139-1:2017
ISO/DIS 10139-1:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Types. 2
4.2 Classes . 2
5 Requirements . 2
5.1 Shore A0 hardness . 2
5.1.1 Shore A0 hardness at 2 h . 2
5.1.2 Shore A0 hardness at 7 d . 2
5.2 Consistency . 2
5.3 Detail reproduction . 3
6 Sampling . 3
7 Test methods . 3
7.1 Ambient conditions for testing . 3
7.2 Shore A0 hardness . 3
7.2.1 Apparatus . 3
7.2.2 Procedure . 3
7.3 Consistency test . 5
7.3.1 Test conditions. 5
7.3.2 Apparatus . 5
7.3.3 Test procedure . 5
7.4 Detail reproduction test . 5
7.4.1 Apparatus . 5
7.4.2 Procedure . 6
8 Requirement for packaging, marking and instructions supplied by the manufacturer .8
8.1 Packaging . 8
8.2 Marking and manufacturer’s instructions for use . 8
Bibliography .10
© ISO 2017 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 10139-1:2017
ISO/DIS 10139-1:2017(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 10139-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This third edition cancels and replaces the second edition (ISO 10139-1:2005), which has been
technically revised.
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 2017 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 10139-1:2017
ISO/DIS 10139-1:2017(E)
Introduction
Clinically, short-term denture-lining materials are used commonly as tissue conditioners and as
temporary soft lining materials. Therefore, the tests are designed to cover the more common usages.
It is recognized that the short-term material, when used as a tissue conditioner, is commonly changed
every few days with the aim of returning the mucosa to a healthy condition as quickly as possible. As
a temporary soft lining, the material is commonly placed in immediate dentures and in dentures that
need to be modified as part of implant treatment. Therefore the specification has been so designed to
necessitate that a material exhibit the required properties over a 7 d period. It is of course recognized
that there are a number of clinical situations where it is appropriate to retain the soft lining in the
denture for periods longer than 7 d. It is also recognized that manufacturers may wish to provide
more than one set of times, temperatures, proportions and procedures to mix or prepare the material
properly in order that the material can satisfy the requirements of more than one type or class.
In an attempt to establish some degree of harmony with the procedures used to evaluate related
dental materials, the detail reproduction test has been adopted for materials also used for functional
impression taking (ISO 4823). As well, in this revision of the standard, the Shore A0 hardness test has
replaced the depth of penetration test, and the consistency test has been reintroduced as a replacement
of the elastic recovery test due to complexity of this method.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this International Standard, but it is recommended that, for the
assessment of possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.
© ISO 2017 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 10139-1:2017
---------------------- Page: 8 ----------------------
oSIST prEN ISO 10139-1:2017
DRAFT INTERNATIONAL STANDARD ISO/DIS 10139-1:2017(E)
Dentistry — Soft lining materials for removable
dentures —
Part 1:
Materials for short-term use
1 Scope
This part of ISO 10139 specifies requirements for the physical properties, test methods, packaging,
marking and manufacturer’s instructions for soft denture lining materials suitable for short-term use,
including functional impression taking using existing removable prosthesis.
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 4823, Dentistry — Elastomeric impression materials
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 following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
soft denture lining material
soft resilient material bonded to the fitting surface of a denture to reduce trauma to t
...
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