oSIST prEN ISO 14356:2022

Dentistry - Duplicating material (ISO/DIS 14356:2022)

ISO 14356:2002 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.

Zahnheilkunde – Dublierwerkstoffe (ISO/DIS 14356:2022)

Médecine bucco-dentaire - Produits pour duplication (ISO/DIS 14356:2022)

L'ISO 14356:2003 spécifie les exigences et les essais concernant les produits pour duplication utilisés en art dentaire et qui sont principalement destinés au façonnage de moules souples nécessaires pour fabriquer des copies positives de revêtement réfractaire à partir de modèles originaux correctement comblés.

Zobozdravstvo - Duplikacijski material (ISO/DIS 14356:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Oct-2022
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 24-Aug-2022
• Due Date: 11-Jan-2023
• Completion Date: 02-Nov-2022
• Ref Project: prEN ISO 14356 - Dentistry - Duplicating material (ISO/DIS 14356:2022)

Relations

• Revised: SIST EN ISO 14356:2003 - Dentistry - Duplicating material (ISO 14356:2003)
• Effective Date: 20-Oct-2021
• Revised: SIST EN ISO 14356:2003 - Dentistry - Duplicating material (ISO 14356:2003)
• Effective Date: 18-Jan-2023
• Revised: SIST EN ISO 14356:2003 - Dentistry - Duplicating material (ISO 14356:2003)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14356:2022
01-oktober-2022
Zobozdravstvo - Duplikacijski material (ISO/DIS 14356:2022)
Dentistry - Duplicating material (ISO/DIS 14356:2022)
Zahnheilkunde – Dublierwerkstoffe (ISO/DIS 14356:2022)
Médecine bucco-dentaire - Produits pour duplication (ISO/DIS 14356:2022)
Ta slovenski standard je istoveten z: prEN ISO 14356
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 14356:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14356:2022

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oSIST prEN ISO 14356:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14356
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-08-17 2022-11-09
Dentistry — Duplicating material
Art dentaire — Produits pour duplication
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 14356:2022(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 2022

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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14356
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

Dentistry — Duplicating material
Art dentaire — Produits pour duplication
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14356:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(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) . 4
5.7 Elastic recovery . 4
5.8 Tear strength. 4
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
7.3.1 General . 5
7.3.2 Preparation of Type 1 materials . 5
7.3.3 Preparation of Type 2 materials . 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
8.3.1 Apparatus and materials . 8
8.3.2 Specimen preparation . 8
8.3.3 Test procedure. 9
8.3.4 Pass/fail determination and expression of results . 9
8.4 Elastic recovery test . 9
8.5 Tear strength test .12
8.5.1 Apparatus and materials .12
8.5.2 Specimen preparation (5 specimens) .13
8.5.3 Test procedure. 14
8.5.4 Calculation of results . 14
8.5.5 Pass/fail determination and expression of results .15
8.6 Fungal growth resistance test — Type 1 agar materials only . 15
8.6.1 Apparatus and materials . 15
8.6.2 Specimen preparation (1 test specimen and 1 control specimen) .15
8.6.3 Test procedure.15
8.6.4 Pass/fail determination . 15
8.6.5 Expression of results . 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
iii
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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(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.
This second edition cancels and replaces the first edition (ISO 14356:2003), which has been technically
revised. This revision updates figures to be consistent with other impression material related
standards.
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oSIST prEN ISO 14356:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 14356:2022(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), Dentistry — Vocabulary
ISO 6873, Dentistry — 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 1 to entry: 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
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
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ISO/DIS 14356:2022(E)
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 to entry: 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 to entry: 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
Note 1 to entry: An immediate container may be an 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 1 to entry: Initial setting times stated in the manufacturer’s instructions are useful to test operators, users,
and standards developers because:
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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(E)
— 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 1 to entry: A primary container may also be an immediate container, and vice versa.
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
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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(E)
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
1 2
which shall also be completely reproduced.
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.
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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(E)
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 document, 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 document, 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.
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.
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oSIST prEN ISO 14356:2022
ISO/DIS 14356:2022(E)
7.4 Pass/fail determinations
Unless otherwise specified in this document, 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.
8.1.3 Pass/fail determination
Compa
...