SIST EN ISO 14356:2003

SLOVENSKI STANDARD
SIST EN ISO 14356:2003
01-september-2003
Dentistry - Duplicating material (ISO 14356:2003)
Dentistry - Duplicating material (ISO 14356:2003)
Zahnheilkunde - Dubliermassen
Art dentaire - Produits pour duplication (ISO 14356:2003)
Ta slovenski standard je istoveten z: EN ISO 14356:2003
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 14356:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14356:2003

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SIST EN ISO 14356:2003
EUROPEAN STANDARD
EN ISO 14356
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2003
ICS 11.060.10
English version
Dentistry - Duplicating material (ISO 14356:2003)
Art dentaire - Produits pour duplication (ISO 14356:2003) Zahnheilkunde - Dubliermassen (ISO 14356:2003)
This European Standard was approved by CEN on 21 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14356:2003 E
worldwide for CEN national Members.

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SIST EN ISO 14356:2003
EN ISO 14356:2003 (E)
CORRECTED  2003-07-16
Foreword
This document (EN ISO 14356:2003) 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 September 2003, and conflicting national
standards shall be withdrawn at the latest by September 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 14356:2003 has been approved by CEN as EN ISO 14356:2003 without any
modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

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SIST EN ISO 14356:2003
EN ISO 14356:2003 (E)
Annex ZA
(normative)
Normative references to international publications with their relevant
European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
Dental vocabulary - Part 1: General and
ISO 1942-1 1989 EN 21942-1 1991
clinical terms
ISO 1942-2 1989 Dental vocabulary - Part 2: Dental EN 21942-2 1992
materials
ISO 1942-3 1989 Dental vocabulary - Part 3: Dental EN 21942-3 1993
instrument
ISO 1942-4 1989 Dental vocabulary - Part 4: Dental EN 21942-4 1993
equipment
ISO 1942-5 1989 Dental vocabulary - Part 5: Terms EN ISO 1942-5 1994
associated with testing
ISO 6873 1998 Dental gypsum products EN ISO 6873 2000
ISO 7490 2000 Dental gypsum-bonded casting EN ISO 7490 2000
investments
ISO 9694 1996 Dental phosphate-bonded casting EN ISO 9694 1998
investments
ISO 11245 1999 Dental restorations - Phosphate-bonded EN ISO 11245 2000
refractory die materials
ISO 11246 1996 Dental ethyl silicate-bonded casting EN ISO 11246 1998
investments
3

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SIST EN ISO 14356:2003

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SIST EN ISO 14356:2003

INTERNATIONAL ISO
STANDARD 14356
First edition
2003-03-01


Dentistry — Duplicating material
Art dentaire — Produits pour duplication





Reference number
ISO 14356:2003(E)
©
ISO 2003

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SIST EN ISO 14356:2003
ISO 14356:2003(E)
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©  ISO 2003
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ii © ISO 2003 — All rights reserved

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SIST EN ISO 14356:2003
ISO 14356:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification by types . 4
5 Material characteristics and properties — Requirements . 4
5.1 General. 4
5.2 Melting temperature — Type 1 materials. 4
5.3 Pouring temperature — Type 1 materials. 4
5.4 Component colours — Type 2 materials .4
5.5 Detail reproduction . 4
5.6 Compatibility with refractory investment (and gypsum if applicable) . 5
5.7 Elastic recovery. 5
5.8 Tear strength . 5
5.9 Resistance to fungal growth — Type 1 materials only . 5
6 Sampling . 5
7 Test methods — General. 5
7.1 Laboratory conditions . 5
7.2 Verification of apparatus function. 5
7.3 Specimen preparation and testing . 5
7.4 Pass/fail determinations. 6
7.5 Expression of test results . 6
8 Specific specimen preparation and test procedures . 6
8.1 Melting temperature test — Type 1 materials only. 6
8.2 Detail reproduction test. 7
8.3 Test for compatibility with refractory investment (and gypsum if applicable). 8
8.4 Elastic recovery test . 9
8.5 Tear strength test. 12
8.6 Fungal growth resistance test — Type 1 agar materials only. 15
9 Requirements for packaging. 15
10 Requirements for labelling. 15
11 Instructions for use — Required information . 16
Annex A (informative) Optional procedure for tear test . 27

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SIST EN ISO 14356:2003
ISO 14356:2003(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 14356 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.

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SIST EN ISO 14356:2003
INTERNATIONAL STANDARD ISO 14356:2003(E)

Dentistry — Duplicating material
1 Scope
This International Standard specifies requirements and tests for the duplicating materials used in dentistry
which are primarily intended for forming flexible moulds needed to produce positive refractory investment
copies of properly blocked-out master models.
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 1942 (all parts), Dental vocabulary
ISO 6873, Dental gypsum products
ISO 7490, Dental gypsum-bonded casting investments
ISO 9694, Dental phosphate-bonded casting investments
ISO 11245, Dental restorations — Phosphate-bonded refractory die materials
ISO 11246, Dental ethyl silicate bonded casting investments
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
block out
to flow or mould waxes and/or materials such as cements, clays and polymeric materials into undercut areas
on a master model, and then shape them so as to leave only those undercuts that are essential to the
subsequent steps in producing a prosthesis that will fit and function optimally
NOTE A blocked-out master model may also include other surface modifications needed relative to construction of a
prosthesis.
3.2
double boiler
container system, usually in three parts, in which the upper container fits into the lower container such that
boiling water in the lower container heats the contents of the lid-covered upper container
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
3.3
duplicating material
elastic material used to make flexible negative copy impressions or moulds of objects (models or casts) into
which a mix of a refractory investment, or another mixture intended for a similar purpose, can be poured to
produce a positive copy of the original object
3.4
non-reversible duplicating material
material which converts from a pourable consistency to a gel or rubber-like state and which thereafter cannot
be returned to the pourable consistency for repeated use
3.5
reversible duplicating material
material which can be recycled for more than one use by changing it, by means of heating, from an elastic gel
state to a pourable consistency, and then returning it to the gel state by cooling
3.6
duplicating process
〈for making metal and ceramic objects〉 method for making positive copies of master models from a negative
mould
NOTE 1 The process is carried out according to the following steps:
 master model is blocked out,
 duplicating material is poured around blocked-out master model and allowed to gel or set,
 master model is separated from the duplicating material, leaving a flexible mould having surfaces that constitute a
negative copy of the surfaces of the master model,
 an investment mixture is poured into the mould to form a refractory model on which polymeric or wax patterns, or
both, can be laid down to form the shapes desired in metal or ceramic castings or on which slurries of porcelain can
be applied for forming desired shapes.
NOTE 2 Gypsum product mixtures or other mixtures may be poured into the moulds to form copies of master models
needed for other purposes.
3.7
effective setting time
〈for materials setting at or near oral or room temperature〉 time measured from the commencement of mixing
components of a material together, or otherwise activating the chemistry involved, to the time at which the
activated material has developed the properties (elasticity, hardness, etc.) that will permit it to be used with
optimal effectiveness in a subsequent step or for its intended purpose
3.8
functional life
〈reversible duplicating material〉 number of times a material can be recycled for use, if handled and used
according to the manufacturer’s instructions, without loss of the properties required to ensure that the material
is fit for the purpose intended
3.9
gelation
〈agar duplicating material〉 transition of a material from a relatively fluid consistency to a gel state in which the
material has developed the elastic properties needed for its intended purpose
3.10
immediate container
packaging component having internal surfaces in direct contact with the material contained
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
NOTE An immediate container may be a unlabelled container protected by more durable outer packaging, such as a
can, carton or drum. If strong enough to protect its contents without outer packaging, an immediate container can serve as
a primary container on which labelling may be required.
3.11
initial setting time
time measured from the commencement of mixing components of a material together, or otherwise activating
the chemistry involved, to the time at which a test procedure, conducted at a specified temperature, indicates
that the mixture has begun to set at a relatively rapid rate, thus indicating that the effective setting time will be
reached at some predictable time thereafter
NOTE Initial setting times stated in the manufacturer’s instructions are useful to test operators, users, and standards
developers because:
 they can often be used for determining whether a product is of a quality suitable for testing or use. For example, if the
initial setting time found by the test operator or user corresponds closely to that stated in the instructions, it can
usually be assumed that the product is suitable for testing or use.
 they can be helpful in the development of standards for certain materials if there is a need for a standard to identify a
reference point in time that can be used as a basis for specifying when certain subsequent procedures should begin.
3.12
investment
〈casting〉 powdered refractory material containing a binder, to be mixed with a specified liquid to form a slurry
that can be poured into a mould made of duplicating material where it is allowed to harden to form a heat-
resistant positive copy of a master model, or which can be poured around patterns to form a heat-resistant
mould used for forming ceramic or metal objects
3.13
master model
definitive cast
〈fixed and removable denture construction〉 positive copy of the hard and/or soft tissues of a dental arch,
usually made by pouring a gypsum product slurry into an impression made of a dental arch
3.14
melt
〈agar reversible duplicating material〉 change a material, by heating, from a gel state to a pourable fluid state
3.15
outer package
wrapping or carton which is used to cover one or more immediate or primary containers in preparation for
retail marketing and which may be required by law or International Standard to bear specified labelling
information
3.16
pouring temperature
〈duplicating material〉 temperature of the material designated in the manufacturer’s instructions for pouring the
material around an object to be duplicated
3.17
primary container
retail marketing packaging component which may or may not be covered by an outer package and which may
be required by law or International Standard to bear specified labelling information
EXAMPLE Bottle, carton, drum, jar, or tube, etc.
NOTE A primary container may also be an immediate container, and vice versa.
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
3.18
refractory
material that retains its effective shape and composition when heated to the maximum temperature required
for its use
3.19
slurry
〈ceramic, gypsum or refractory investment〉 mixture, consisting of a powder and water, or a powder and
another liquid, having a consistency that will allow it to be poured around patterns or into moulds, or to be
otherwise applied, and then be allowed or caused to harden so as to form a desired shape
3.20
storage
holding of a material in an immediate container in a protected environment before the container is opened for
the first use, and between subsequent openings of the container
3.21
store, verb
〈melted agar reversible duplicating material〉 to hold a material at the temperature specified in the
manufacturer’s instructions for keeping it at pouring consistency
4 Classification by types
There are two types of duplicating material:
 Type 1: Reversible duplicating materials
 Type 2: Non-reversible duplicating materials
5 Material characteristics and properties — Requirements
5.1 General
In order to arrive at an objective evaluation of a duplicating material, it is necessary to review Clauses 9, 10
and 11 before any further steps in the evaluation are begun.
5.2 Melting temperature — Type 1 materials
When tested in accordance with 8.1, the melting temperature shall not exceed the maximum stated in the
manufacturer's instructions [11 c) 2)].
5.3 Pouring temperature — Type 1 materials
The manufacturer's recommended maximum pouring temperature [11 c) 4)] shall not exceed 54 °C.
5.4 Component colours — Type 2 materials
Different components intended for use in the same mixture shall be supplied in contrasting colours in order to
provide a means of determining when the components have been thoroughly mixed.
5.5 Detail reproduction
When tested according to 8.2, the duplicating material shall copy line b scribed on the test block (Figure 1), as
a positive reproduction, for the full length of the distance between lines d and d , both of which shall also be
1 2
completely reproduced.
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
5.6 Compatibility with refractory investment (and gypsum if applicable)
When tested according to 8.3, the duplicating materials shall impart a smooth surface to, and separate cleanly
from, the investment or gypsum product poured against it. The investment and gypsum material poured
against the lined surface of the duplicating material specimen shall copy line c for the full length of the
distance between lines d and d (Figure 1).
1 2
5.7 Elastic recovery
When tested according to 8.4, the elastic recovery shall be at least 96,50 %.
5.8 Tear strength
When tested according to 8.5, the tear resistance shall be at least 0,3 N/mm for Type 1 materials and at least
1,0 N/mm for Type 2 materials.
5.9 Resistance to fungal growth — Type 1 materials only
When tested in accordance with 8.6, the specimens shall exhibit no fungal growth.
6 Sampling
Samples of material to be tested shall be procured from a single manufacturing batch as packaged for retail
marketing.
NOTE Amounts of approximately 7,5 l of Type 1 materials and 3,7 l of Type 2 materials are usually enough for
conducting all of the tests and for the considerable practice that may be necessary for the test operator to become
proficient in specimen preparation and testing.
7 Test methods — General
7.1 Laboratory conditions
Unless otherwise specified in this International Standard, all specimen preparation and testing shall be
conducted under ambient laboratory conditions of (23 ± 2) °C and (50 ± 10) % relative humidity. Unless
otherwise specified in this International Standard, all equipment and materials used in the tests shall be
brought to ambient temperature before use in specimen preparation and testing procedures.
7.2 Verification of apparatus function
Examine all accessories, instruments and equipment before they are used in order to determine whether they
are in acceptable working order. Perform whatever calibration steps are necessary to ensure that the items
are in compliance with the specifications stated for them in this International Standard, or in any related
supporting standard.
7.3 Specimen preparation and testing
7.3.1 General
Unless otherwise specified, prepare and manipulate the materials to be used for forming the test specimens
employing the equipment, and following the procedures, recommended in the manufacturer’s instructions [see
11 b), 11 c) and 11 d)].
Time the schedules for specimen preparation and testing using a timing device such as a stopwatch accurate
to ± 1 s over a 30 s period.
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
7.3.2 Preparation of Type 1 materials
Use the double-boiler method for melting Type 1 materials. The amount of melted material prepared for
testing purposes at any one time shall be approximately 700 ml. Melted material remaining after the
preparation of one set of specimens may be used for forming other sets of specimens to be formed and tested
on the same day, providing that the material can be kept at the recommended temperature and consistency
for pouring without re-melting.
7.3.3 Preparation of Type 2 materials
For Type 2 materials, use mass/mass proportioning of the components to be mixed. A volume of
approximately 20 ml shall be prepared for each specimen tested.
7.4 Pass/fail determinations
Unless otherwise specified in this International Standard, the minimum number of specimens required for
pass/fail determinations is either three or five, as indicated by an entry appearing beside the related specimen
preparation or test procedure title.
Unless otherwise specified, the following rules apply.
 For a three-specimen minimum, make and test a series of three specimens initially. If at least two of the
three specimens comply with the related requirement, the material passes. If none complies, the material
fails. If only one specimen complies, make three additional specimens. If all three of the additional
specimens comply, the material passes; otherwise the material fails.
 For a five-specimen minimum, make and test a series of five specimens initially. If at least four of the five
specimens comply with the related requirement, the material passes. If only one or two specimens
comply, the material fails. If only three specimens comply, make a series of five additional specimens. If
all five of the second series of specimens comply, the material passes; otherwise the material fails.
7.5 Expression of test results
Report the number of specimens tested, the number complying with the specified requirement, and whether
the material passes or fails.
8 Specific specimen preparation and test procedures
8.1 Melting temperature test — Type 1 materials only
8.1.1 Apparatus
8.1.1.1 Ceramic, glass or stainless steel double boiler system (3.2) having a component that will
accommodate a volume of at least 700 ml of the melted duplicating material.
8.1.1.2 Temperature-measuring device, such as a calibrated 76 mm immersion thermometer having
graduations of 0,1 °C, or equivalent.
8.1.1.3 Heat source, to provide the temperatures needed for the melting process.
8.1.2 Test procedure (one test)
Observe the rate of melting for the specified volume of material (7.3.2). When the material approaches the
final stages of melting, use the device (8.1.1.2) to measure temperature of the material periodically until the
moment at which the entire volume is free of lumps and granules. Record the temperature for this occurrence.
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SIST EN ISO 14356:2003
ISO 14356:2003(E)
8.1.3 Pass/fail determination
Compare the melting temperature recorded according to 8.1.2 with the maximum temperature stated in the
manufacturer's instructions [11 c) 2)]. Then record whether this temperature complies with the requirement
stated in 5.2.
8.2 Detail reproduction test
8.2.1 Apparatus and materials
8.2.1.1 Test block (see Figure 1)
8.2.1.2 Ring mould and ring-mould retainer (see Figure 2)
8.2.1.3 Putty-like material for covering external orifices of holes in the ring mould so as to prevent
escape of the fluid duplicating material.
8.2.1.4 Flat glass or metal plate, approximately 50 mm × 50 mm and at least 3 mm thick.
8.2.1.5 Temperature-conditioning unit (oven, air cooler or water bath), capable of providing an
environment in which t
...