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

Status
Published
Public Enquiry End Date
04-Sep-2017
Publication Date
11-Jun-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-May-2018
Due Date
29-Jul-2018
Completion Date
12-Jun-2018

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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.

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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

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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.
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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
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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
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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
...

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