EN ISO 4823:2015

SLOVENSKI STANDARD
01-oktober-2015
1DGRPHãþD
SIST EN ISO 4823:2001
SIST EN ISO 4823:2001/A1:2008
SIST EN ISO 4823:2001/AC:2006
Zobozdravstvo - Elastomerni materiali za odtise (ISO 4823:2015)
Dentistry - Elastomeric impression materials (ISO 4823:2015)
Zahnheilkunde - Elastomere Abformmaterialien (ISO 4823:2015)
Médecine bucco-dentaire - Produits pour empreintes, à base d'élastomères (ISO
4823:2015)
Ta slovenski standard je istoveten z: EN ISO 4823:2015
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 4823
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.060.10 Supersedes EN ISO 4823:2000
English Version
Dentistry - Elastomeric impression materials (ISO 4823:2015)
Médecine bucco-dentaire - Matériaux à empreintes, à base Zahnheilkunde - Elastomere Abformmaterialien (ISO
d'élastomères (ISO 4823:2015) 4823:2015)
This European Standard was approved by CEN on 20 June 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4823:2015 E
worldwide for CEN national Members.

Contents Page
European foreword .3

European foreword
This document (EN ISO 4823:2015) 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4823:2000.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 4823:2015 has been approved by CEN as EN ISO 4823:2015 without any modification.
INTERNATIONAL ISO
STANDARD 4823
Fourth edition
2015-08-01
Dentistry — Elastomeric impression
materials
Médecine bucco-dentaire — Matériaux à empreintes, à base
d’élastomères
Reference number
ISO 4823:2015(E)
©
ISO 2015
ISO 4823:2015(E)
© ISO 2015, 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
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the requester.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 4823:2015(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements for packaging, labelling, and information in manufacturer’s instructions .2
5.1 Packaging requirements . 2
5.2 Labelling requirements . 3
5.2.1 Outer packages (containing one or more primary containers) . . 3
5.2.2 Primary containers within outer packaging . 3
5.3 Requirements for information in manufacturer’s instructions . 3
5.3.1 General. 3
5.3.2 Identifying information . . 3
5.3.3 Specific instructions for use . 4
5.4 Requirements for characteristics and properties . 4
5.4.1 Component colours . 4
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 4
5.4.3 Consistency . 5
5.4.4 Working time. 5
5.4.5 Detail reproduction . 5
5.4.6 Linear dimensional change . 5
5.4.7 Compatibility with gypsum . 5
5.4.8 Elastic recovery . 5
5.4.9 Strain-in-compression . 5
6 Pre-test planning approaches . 6
6.1 Sampling . 6
6.2 Pre-test product examinations . 6
6.2.1 Examinations for compliance with labelling requirements . 6
6.2.2 Examinations for effectiveness of the packaging . 6
6.2.3 Examinations for compliance with requirements for instructions for use . 6
6.3 Essential pre-test preparatory practices . 7
6.3.1 Laboratory conditions . 7
6.3.2 Apparatus function verification steps . 7
6.3.3 Volume of materials to be mixed for each specimen . 7
6.3.4 Order for conducting examinations and tests . 7
6.3.5 Standardized approaches to proportioning, mixing, and handling of hand
mixed materials to be tested. 7
6.3.6 Timing for the specimen preparation and test procedures . 7
6.3.7 Simulated oral time/temperature treatment of specimens formed in
completely closed mould assemblies . 7
6.4 Pass/fail determinations . 8
6.5 Expression of test results . 8
7 Test methods — Specific . 8
7.1 Mixing-time . 8
7.1.1 Apparatus . 8
7.1.2 Specimen preparation and test procedure (five specimens) . 8
7.1.3 Pass/fail determination and expression of results. 8
7.2 Consistency . 8
7.2.1 Apparatus and materials . 8
7.2.2 Advance preparation steps. 9
7.2.3 Specimen preparation and test procedure (3 specimens) . 9
7.2.4 Pass/fail determination and expression of results.10
ISO 4823:2015(E)
7.3 Working-time .10
7.3.1 Apparatus and materials applicable to the Type 0 materials .10
7.3.2 Working time test for the Type 0 materials .10
7.3.3 Apparatus and materials applicable to the Types 1, 2, and 3 .12
7.3.4 Pretest apparatus function verification and assembly .12
7.3.5 Pass/fail determination and expression of results.13
7.4 Detail reproduction .13
7.4.1 Apparatus and materials .13
7.4.2 Specimen preparation (three specimens) .14
7.4.3 Test procedure .14
7.4.4 Pass/fail determination and expression of results.14
7.5 Linear dimensional change .15
7.5.1 Apparatus and materials .15
7.5.2 Test block line-length measurement procedure .15
7.5.3 Specimen preparation (three specimens) .15
7.5.4 Test specimen measurement .16
7.6 Compatibility with gypsum .16
7.6.1 Apparatus and materials .16
7.6.2 Specimen preparation .17
7.6.3 Test procedure .18
7.6.4 Pass/fail determination and expression of results.18
7.7 Elastic recovery .18
7.7.1 Apparatus and materials .18
7.7.2 Specimen preparation .18
7.7.3 Test procedure .19
7.7.4 Calculation of results .19
7.7.5 Pass/fail determination and expression of results.19
7.8 Strain-in-compression .20
7.8.1 Apparatus .20
7.8.2 Specimen preparation .20
7.8.3 Test procedure .20
7.8.4 Calculation of results .20
7.8.5 Pass/fail determination and expression of results.20
Annex A (normative) Figures cited in this International Standard .21
Annex B (normative) Standardized hand mixing methods .35
Annex C (informative) Working-time test apparatus components − Possible sources .38
Bibliography .39
iv © ISO 2015 – All rights reserved

ISO 4823:2015(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This fourth edition cancels and replaces the third edition (ISO 4823:2000), which has been technically
revised with the following changes:
— modification of the sequence of requirements having the requirements for packaging and labelling
listed before the requirements for characteristics and properties;
— the restriction that the working time shall be at least 30 s longer than the mixing time was eliminated;
this was considered necessary in view of the fact that several products have shorter working time;
— working time test procedure using the dead weight method (Sink-in method) for Type 0 materials
which had been exempt from this requirement in the third edition was introduced (see 7.3.2);
— the current displacement Rheometer procedure stated in ISO 4823:2000 will continue to be used
for testing Type 1, 2, and 3 materials without modifications;
— concerning the order in which some clauses are presented, whereas in later years, most dental
product standards have been structured to have the requirements and test methods clauses appear
before the requirements for labelling and instructions for use clauses, this International Standard
gives first ordering to the labelling and instructions for use requirements. This change was thought
to be necessary because experience informs us that test operators will be better equipped to obtain
success in testing if they first take into account the information available in the labelling and in the
instructions for use;
— Clause 6 has been added for reasons explained in its first paragraph;
— concerning the Annexes
— Annex A was created due to the ISO Central Secretariat suggestion that all figures, grouped
together instead of being presented individually on related pages of the text, are to be presented
in a normative Annex and numbered according to existing rules. This is to make it easier for the
figures to be located by users of the document;
ISO 4823:2015(E)
— Annex B provides for standardized hand mixing methods to be used by test operators so that
specimen preparation mixing of the test specimens will be uniform and consistently fairer to
the various products;
— Annex C identifies sources for the working-time test apparatus and the linear variable
displacement transducer (LVTD).
vi © ISO 2015 – All rights reserved

INTERNATIONAL STANDARD ISO 4823:2015(E)
Dentistry — Elastomeric impression materials
1 Scope
This International Standard specifies the requirements and tests that the state-of-the art body of
knowledge suggests for helping determine whether the elastomeric impression materials, as prepared
for retail marketing, are of the quality needed for their intended purposes.
NOTE This International Standard does not address possible biological hazards associated with the
materials. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of
such hazards.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 6873, Dentistry — Gypsum products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
consistency
degree of firmness with which particles of a material, prepared for use, cohere so as to allow the
material to flow, or resist flow, as required to achieve the purpose for which it is intended
3.2
elastic recovery test
DEPRECATED: compression set
DEPRECATED: permanent deformation
DEPRECATED: recovery from deformation
〈elastic impression materials〉 method of determining whether the materials possess the elastic
properties required to recover adequately after deformation occurring when the materials used for
forming impressions are removed from the mouth
3.3
extrusion mixing
method by which two or more material components are extruded simultaneously from their separate
primary containers through a special mixing tip from which the material components emerge as a
homogeneous mixture
3.4
hand mixing
method of mixing the components of a material by means of manual kneading or spatulation
3.5
primary packaging
container designed to come into direct contact with the product
[SOURCE: ISO 21067:2007, 2.2.2, modified — “packaging” replaced by “container” in the definition.]
ISO 4823:2015(E)
3.6
mixing time
time, measured from first contact between different components of a material being mixed, required
to achieve a homogeneous mixture when the components are mixed according to the manufacturer’s
instructions
Note 1 to entry: The time of first contact between extrusion-mixed material components is defined as the time
when the material components can be seen entering into the mixing nozzle.
3.7
outer package
wrapping or carton, which may be required by law or a standard to bear specified labelling, used to
cover one or more primary containers in preparation for retail marketing
3.8
strain-in-compression test
〈elastic impression materials〉 method of measuring the flexibility/stiffness property ranges of materials
so as to determine whether the set materials, when formed as impressions, can be removed from the
mouth without injury to impressed oral tissues and will have adequate stiffness in the more flexible
portions of impressions to resist deformation when model-forming products are poured against them
3.9
working time
period of time beginning with the commencement of mixing and ending before the material being
mixed has begun to exhibit elastic properties that will prevent the material from being manipulated
as required to form an impression or a mould having the desired surface detail and dimensional
characteristics
4 Classification
Materials covered by this International Standard are classified according to the following consistencies
determined immediately after completion of mixing according to the manufacturer’s instructions (see
5.3):
— Type 0: putty consistency;
— Type 1: heavy-bodied consistency;
— Type 2: medium-bodied consistency;
— Type 3: light-bodied consistency.
5 Requirements for packaging, labelling, and information in manufacturer’s
instructions
5.1 Packaging requirements
No packaging requirements are specified in this International Standard, but it is important for
manufacturers to take into account that the packaging should be such that it will not contaminate
or permit contamination of ingredients of the material components during recommended storage
conditions. Structure of the primary packaging should also be such that no leakage or inadvertent
extrusion of the contents can occur during storage and such that the containers will not rupture during
use of the extrusion methods recommended by the manufacturer.
2 © ISO 2015 – All rights reserved

ISO 4823:2015(E)
5.2 Labelling requirements
5.2.1 Outer packages (containing one or more primary containers)
Labelling of the outer packaging prepared for retail marketing containing one or more primary
containers shall bear the following information:
a) recommended storage conditions for the unopened package;
b) brand name;
c) name and address of the manufacturer or the name of another company authorized by the
manufacturer to market the material under a different brand name;
d) identification of the consistency of the material as putty, heavy-bodied, medium-bodied, or light-
bodied (see Clause 4) (the type number may also be included);
e) manufacturer’s batch reference(s);
f) USE BEFORE DATE, identified as such, beyond which the material may not exhibit its best
properties. The date shall be expressed as a six-digit number, for example, 2014-09, where the first
four digits indicate the year (2014) and the last two digits indicate the month (September);
g) minimum volume that would result from mixing the entire component contents included in the
outer package.
5.2.2 Primary containers within outer packaging
Labels for primary containers shall bear the following information:
a) brand name;
b) name of the manufacturer or name of another company authorized to market the material under a
different brand name;
c) component identification (not required when the components for extrusion mixing are supplied in
separate but joined primary containers);
d) manufacturer’s batch references.
5.3 Requirements for information in manufacturer’s instructions
5.3.1 General
Each package in which the components of an impression material are prepared for retail marketing shall
be accompanied by the instructions and other information needed to ensure optimum performance of
the material in clinical practice
5.3.2 Identifying information
The following identifying information is required:
a) trade-name or brand-name of the product;
b) chemical nature of the elastomeric system: for example, polyether, polysulfide, silicone
(condensation type), or silicone (vinyl polysiloxane, addition type).
ISO 4823:2015(E)
5.3.3 Specific instructions for use
Where applicable, the specific instructions for use shall include the following:
a) recommended storage conditions after the initial opening of the primary containers;
b) statements indicating that working time and other characteristics of the material can be affected
significantly by the following factors, as may be applicable:
— room temperature variations;
— variations in the speed and friction involved in mixing;
— hand/fingertip temperatures when kneading putty mixes;
— moisture contamination or relative humidity;
— contamination, either due to direct contact with latex dam or gloves used in clinical practice or
due to the presence of such contaminants on teeth at the time they are impressed;
c) proportions for hand-spatulated mixes (mass to mass and volume to volume);
d) recommended mixing apparatus and procedures to include the generic identification of any hand
coverings (gloves or polymer sheeting) that should be used to avoid contamination of the materials
during hand manipulation;
e) mixing time required to obtain a homogeneous mixture of an amount of the material having a
volume of 15 ml (see 5.3 and Annex B);
f) working time;
g) minimum time the impression should remain in the mouth before removal;
h) minimum or maximum time lapse, or both, permitted between removal of the impression from the
mouth and pouring the gypsum product into the impression;
i) identification of at least two gypsum products, complying with requirements of ISO 6873, which
the impression material manufacturer has found to be compatible with the impression material
being tested: one Type 3 product (dental stone, model) and either one Type 4 product or one Type 5
product (dental stone, high strength);
j) when the manufacturer’s instructions state that an impression made of a material may be
disinfected, the disinfecting procedure shall be described in detail and a reference indicating that
the disinfection procedure will not alter the potential of the impression for optimum performance
shall also be identified;
k) when a manufacturer claims that a material in itself is antimicrobial and will remain so without
further treatment after the impression is removed from the mouth, the manufacturer shall identify
the reference on which the claim is based.
5.4 Requirements for characteristics and properties
5.4.1 Component colours
Different components intended for use in the same mixture shall be supplied in contrasting colours to
provide a means of determining when the components have been thoroughly mixed.
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes)
When the impression material components are combined according to the manufacturer’s instructions
and the results of the mixing are evaluated according to 7.1, the average time required to achieve a
homogeneous mixture (essentially streak-free) shall not exceed the time stated by the manufacturer.
4 © ISO 2015 – All rights reserved

ISO 4823:2015(E)
5.4.3 Consistency
When tested according to 7.2, the test disc diameter shall be in the range given in Table 1 for the
consistency assigned to the material by the manufacturer.
5.4.4 Working time
When tested according to 7.3, the working time shall not be less than that stated in the manufacturer’s
instructions.
5.4.5 Detail reproduction
When tested according to 7.4, the line width reproduced shall not exceed the appropriate value given in
Table 1.
5.4.6 Linear dimensional change
When tested according to 7.5, the linear dimensional change shall not exceed the appropriate value
given in Table 1.
5.4.7 Compatibility with gypsum
The impression material shall impart a smooth surface to and separate cleanly from the gypsum model
material poured against it. When tested according to 7.6, the line width reproduced shall not exceed the
appropriate value given in Table 1.
5.4.8 Elastic recovery
When tested according to 7.7, the elastic recovery shall be greater than or equal to the value given in
Table 1.
5.4.9 Strain-in-compression
When tested according to 7.8, the strain-in-compression shall be in the appropriate range given in
Table 1.
Table 1 — Characteristic and physical property requirements
Test subclause no. and description
7.2 7.4 7.5 7.6 7.7 7.8
Consistency Detail Linear Compatibility Elastic Strain-in-
reproduction dimensional with gypsum recovery compression
(Test disc
Type
change
diameter) (Line width (Line width % %
a a
reproduced) % reproduced)
mm min.
µm max. µm
min max  min max
0 — 35 75 1,5 75 96,5 0,8 20
1 — 35 50 1,5 50 96,5 0,8 20
2 31 41 20 1,5 50 96,5 2,0 20
3 36 — 20 1,5 50 96,5 2,0 20
a
The line reproduction shall be considered satisfactory if the required line a, b, or c is continuous between the lines d
and d . See test block in Figure A.12.
ISO 4823:2015(E)
6 Pre-test planning approaches
The information in this Clause is provided to help test operators avoid losses of time due to trial and
error efforts occurring when such information is not taken into account before test procedures, such as
those described in Clause 7, are begun.
6.1 Sampling
Observe the following guidelines when procuring samples of materials for testing.
a) Procure only samples that have been packaged for retail or franchise marketing and that have
labelling Use by dates that have not expired.
b) Wherever possible, select only those samples that have the same lot (batch) number [see 5.2.1 e)].
c) Sample size required
— as much as 900 ml might be needed for conducting all of the required tests and for the
considerable practice, that might be necessary for the test operator to become proficient in
specimen preparation and testing, and
— for the gypsum materials needed for the impression material compatibility with gypsum test,
at least 1 000 g.
6.2 Pre-test product examinations
These examinations are helpful in determining whether the sample procured (6.1) is fit for objective
testing.
6.2.1 Examinations for compliance with labelling requirements
Examine the consumer packaging components for compliance with the labelling requirements before
any attempt to open a packaging component has defaced or obliterated any labelling entry information
needed for storage or use of the product (for example, Use by date).
NOTE At this point, it is recommended that the following information about the product be recorded for
future reference in a test record format, if possible:
— brand name, type, and class of the product, if applicable, along with an added numeric or alpha numeric
symbol for the sample;
— Use by date for the product;
— lot number for each component.
6.2.2 Examinations for effectiveness of the packaging
Before opening any primary packaging container, examine it for possibilities that the quality of
the content might have been compromised since its manufacture. For example, evidence such as the
following:
— loose tube caps or canister lids or leakage;
— container rupture or punctures;
— shrinkage of the content of a container such as can be detected by sight, sound, or touch.
Caution — Do not use any compromised materials for preparing specimens.
6.2.3 Examinations for compliance with requirements for instructions for use
6 © ISO 2015 – All rights reserved

ISO 4823:2015(E)
a) Before discarding any secondary packaging
— examine the labels to determine whether they include any of the instructions for use information
specified in 5.3, and
— locate and retain any instruction sheet that might have been provided outside the primary
container.
b) Examine the instructions for use for compliance with requirements stated in 5.3.3.
6.3 Essential pre-test preparatory practices
6.3.1 Laboratory conditions
Unless otherwise specified in this International Standard, conduct all specimen preparation and
testing under the ambient laboratory conditions of (23 ± 2) °C and (50 ± 10) % relative humidity. And,
unless otherwise specified, bring all equipment and materials to be used in the tests to the ambient
temperature before beginning specimen preparation.
6.3.2 Apparatus function verification steps
a) Examine all accessories, instruments, and equipment for functional effectiveness before they are
used in a test.
b) Clear all instrumentation or equipment surfaces that will come in contact with the specimen
material of any contaminants that might influence the test result.
c) Perform whatever calibration steps necessary to ensure that the items comply with specifications
stated for them in this International Standards or in the normative supporting reference ISO 6873.
6.3.3 Volume of materials to be mixed for each specimen
Unless otherwise specified in this International Standard, the volume mixed for each specimen shall be
(15 ± 0,5) ml.
6.3.4 Order for conducting examinations and tests
a) Irrespective of the number of tests required, always conduct the examinations first and then
conduct the mixing time test, the component colour evaluation, and the working time test, in that
order.
b) When there is a need to conduct all of the other tests, conduct all of the tests in the order they are
described in Clause 7, unless there is some compelling reason not to do so.
6.3.5 Standardized approaches to proportioning, mixing, and handling of hand mixed
materials to be tested
See Annex B.
6.3.6 Timing for the specimen preparation and test procedures
A timing device such as a stop watch accurate to 1 s over a 30 s period shall be used for timing each
requiring specimen preparation and test step.
6.3.7 Simulated oral time/temperature treatment of specimens formed in completely closed
mould assemblies
(For the detail reproduction, linear dimensional change, elastic recovery, and strain-in-compression
test specimens)
ISO 4823:2015(E)
Immediately after the specimen forming material has been completely enclosed in the specimen forming
assembly, the entire assembly shall be conditioned at (35 ± 1) °C for the time period recommended by
the manufacturer for leaving the material in the mouth.
6.4 Pass/fail determinations
Except for the consistency and working time tests, the minimum number of specimens to be tested for
pass/fail determinations shall either be three or five, as indicated in the first Specimen preparation
subclause for each related test procedure.
a) For a three-specimen minimum, make a series of three specimens initially. If at least two of
the three specimens comply with the related requirement, the material passes. If none comply,
the material fails. If only one specimen complies, make three additional specimens. If two of the
additional specimens comply, the material passes. Otherwise, the material fails.
b) 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 four of the second series of specimens comply, the material passes. Otherwise, the
material fails.
6.5 Expression of test results
Record the number of specimens tested and whether the material passes or fails.
7 Test methods — Specific
7.1 Mixing-time
7.1.1 Apparatus
7.1.1.1 Recommended mixing apparatus [5.3.3 d)].
7.1.1.2 Timing device (6.3.6).
7.1.2 Specimen preparation and test procedure (five specimens)
Proportion and mix the required volume of material (6.3.3) for each specimen. Record the time
required to obtain a homogeneous mixture for each specimen. Calculate the mean of the results for the
five specimens.
NOTE Mixes made for this test can be used to provide increments of material needed for the consistency test
(7.2).
7.1.3 Pass/fail determination and expression of results
Determine whether the mean result obtained in accordance with 7.1.2 complies with 5.4.2 and report
the results.
7.2 Consistency
7.2.1 Apparatus and materials
7.2.1.1 Two glass plates, a loading plate of approximately 60 mm by 60 mm and at least 3 mm thick
and a base plate of dimensions equal to or greater than those of the loading plate.
8 © ISO 2015 – All rights reserved

ISO 4823:2015(E)
7.2.1.2 Material delivery system, for delivering a volume of (0,5 ± 0,02) ml of the material onto the
base plate
...