SIST EN ISO 10139-1:2005
(Main)Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2005)
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2005)
ISO 10139-1:2005 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for denture lining materials suitable for short-term use.
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1: Werkstoffe für kurzzeitige Anwendungen (ISO 10139-1:2005)
Dieser Teil von ISO 10139 legt Anforderungen an die physikalischen Eigenschaften, Prüfverfahren, Verpackung, Kennzeichnung und Gebrauchsanweisung für Prothesenunterfütterungswerkstoffe fest, die für kurzzeitige Anwendungen geeignet sind.
Art dentaire - Produits souples pour intrados de protheses dentaires amovibles - Partie 1: Produits pour usage a court terme (ISO 10139-1:2005)
L'ISO 10139-1:2005 spécifie les exigences relatives aux propriétés physiques, aux méthodes d'essai, au conditionnement, au marquage et aux instructions du fabricant concernant les produits souples pour intrados de prothèses dentaires amovibles utilisables à court terme.
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 1. del: Materiali za kratkotrajno uporabo (ISO 10139-1:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10139-1:2005
01-junij-2005
1DGRPHãþD
SIST EN 30139-1:2000
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 1. del:
Materiali za kratkotrajno uporabo (ISO 10139-1:2005)
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term
use (ISO 10139-1:2005)
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1:
Werkstoffe für kurzzeitige Anwendungen (ISO 10139-1:2005)
Art dentaire - Produits souples pour intrados de protheses dentaires amovibles - Partie 1:
Produits pour usage a court terme (ISO 10139-1:2005)
Ta slovenski standard je istoveten z: EN ISO 10139-1:2005
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 10139-1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10139-1:2005
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SIST EN ISO 10139-1:2005
EUROPEAN STANDARD
EN ISO 10139-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 11.060.10 Supersedes EN 30139-1:1994
English version
Dentistry - Soft lining materials for removable dentures - Part 1:
Materials for short-term use (ISO 10139-1:2005)
Art dentaire - Produits souples pour intrados de prothèses Zahnheilkunde -Weichbleibende Unterfütterungswerkstoffe
dentaires amovibles - Partie 1: Produits pour usage à court für Prothesen - Teil 1: Werkstoffe für kurzzeitige
terme (ISO 10139-1:2005) Anwendungen (ISO 10139-1:2005)
This European Standard was approved by CEN on 3 February 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10139-1:2005: E
worldwide for CEN national Members.
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SIST EN ISO 10139-1:2005
EN ISO 10139-1:2005 (E)
Foreword
This document (EN ISO 10139-1:2005) 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 August 2005, and conflicting national
standards shall be withdrawn at the latest by August 2005.
This document supersedes EN 30139-1:1994.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 10139-1:2005 has been approved by CEN as EN ISO 10139-1:2005 without any
modifications.
2
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SIST EN ISO 10139-1:2005
INTERNATIONAL ISO
STANDARD 10139-1
Second edition
2005-02-15
Dentistry — Soft lining materials for
removable dentures —
Part 1:
Materials for short-term use
Art dentaire — Produits souples pour intrados de prothèses dentaires
amovibles —
Partie 1: Produits pour usage à court terme
Reference number
ISO 10139-1:2005(E)
©
ISO 2005
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SIST EN ISO 10139-1:2005
ISO 10139-1:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 10139-1:2005
ISO 10139-1:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification. 1
4.1 Types. 1
4.2 Classes. 2
5 Requirements . 2
5.1 Development of elastic recovery. 2
5.2 Change in compliance with age as measured by depth of penetration . 2
6 Sampling . 3
7 Test methods. 3
7.1 Ambient conditions for testing. 3
7.2 Measurement of elastic recovery . 3
7.3 Test of compliance as measured by depth of penetration . 5
8 Requirement for labelling, marking and instructions supplied by the manufacturer. 8
8.1 Packaging . 8
8.2 Marking . 8
8.3 Manufacturer's instructions for use. 9
Bibliography . 10
© ISO 2005 – All rights reserved iii
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SIST EN ISO 10139-1:2005
ISO 10139-1:2005(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 second edition cancels and replaces the first edition (ISO 10139-1:1991), 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 2005 – All rights reserved
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SIST EN ISO 10139-1:2005
ISO 10139-1:2005(E)
Introduction
Clinically, short-term denture-lining materials are used commonly as tissue conditioners and as temporary soft
lining materials. It is believed that their use as functional impression materials is now less common. 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 its earliest stage, the soft lining material is usually removed from the mouth so that it can be adjusted and
tidied. If the material attains a particular level of elastic recovery, removal from the mouth will not result in
unacceptable distortion. Therefore, denture lining materials for short-term use are classified in this part of
ISO 10139 according to the time at which 10 % elastic recovery is established. (When stating the time at
which 10 % elastic recovery is established, the manufacturer is to take, as zero time, the end of mixing.)
The other classification is related to initial compliance.
Although it is not claimed that any particular time at which 10 % elastic recovery is attained or level of
compliance is superior to another, these classifications are intended to assist clinicians who will now have
more information with which to make an informed choice.
In an attempt to establish some degree of harmony with the procedures used to evaluate related dental
materials, the displacement rheometer, which is used to measure the setting characteristics of elastomeric
impression materials, has been adopted to measure elastic recovery of the short-term soft lining materials
(ISO 4823:2000). This method supersedes the consistency test.
This part of ISO 10139 does not include specific qualitative and quantitative requirements for freedom from
biological hazard. When possible biological or toxicological hazards need to be assessed, refer to ISO 7405
(see the Bibliography).
© ISO 2005 – All rights reserved v
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SIST EN ISO 10139-1:2005
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SIST EN ISO 10139-1:2005
INTERNATIONAL STANDARD ISO 10139-1:2005(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 denture lining materials suitable for short-term use.
2 Normative references
The following referenced documents are indispensable for the application 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 3696, Water for analytical laboratory use — Specification and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
tissue conditioning material
soft lining material, placed in the fitting surface of a denture, that is intended to be in contact with the
denture-supporting mucosa, commonly for a period of up to 7 d, with the aim of assisting its return to a healthy
condition
3.2
temporary soft lining material for dentures
soft lining material for dentures that is intended to be used for a limited period to improve fit, retention and
comfort
4 Classification
4.1 Types
Materials for short-term use shall be classified into the following types according to development of elastic
recovery (see 5.1) as determined in accordance with 7.2:
Type A: allows short time before removal from the mouth (5 min or less than 5 min);
Type B: allows extended time before removal from the mouth (more than 5 min).
© ISO 2005 – All rights reserved 1
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SIST EN ISO 10139-1:2005
ISO 10139-1:2005(E)
4.2 Classes
The materials shall be further subdivided into classes according to their initial compliance as measured by
initial resistance to indentation (see 5.2) determined in accordance with 7.3:
Class 1: high initial compliance;
Class 2: low initial comp
...
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