SIST EN ISO 21563:2021

SLOVENSKI STANDARD
oSIST prEN ISO 21563:2020
01-junij-2020
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO/DIS
21563:2020)
Dentistry - Hydrocolloid impression materials (ISO/DIS 21563:2020)
Zahnheilkunde - Hydrokolloidabformmaterialien (ISO/DIS 21563:2020)
Médecine bucco-dentaire - Produits pour empreintes à base d'hydrocolloïdes (ISO/DIS
21563:2020)
Ta slovenski standard je istoveten z: prEN ISO 21563
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 21563:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 21563:2020

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oSIST prEN ISO 21563:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21563
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-06 2020-06-29
Dentistry — Hydrocolloid impression materials
Médecine bucco-dentaire — Produits pour empreintes à base d'hydrocolloïdes
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 21563:2020(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 2020

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oSIST prEN ISO 21563:2020
ISO/DIS 21563:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Published in Switzerland
ii © ISO 2020 – All rights reserved

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oSIST prEN ISO 21563:2020
ISO/DIS 21563:2020(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification of agar hydrocolloid impression materials . 3
5 Requirements — Characteristics and properties . 4
6 Pre-test planning approaches . 4
6.1 Sampling . 5
6.2 Pre-test product examinations . 5
6.2.1 Examinations for compliance with labelling requirements . 5
6.2.2 Examinations for effectiveness of the packaging . 5
6.2.3 Examinations for compliance with requirements for instructions for use . 5
6.3 Essential pre-test preparatory practices . 6
6.3.1 Laboratory conditions . 6
6.3.2 Apparatus function verification steps . 6
6.3.3 Test material handling and use . 6
6.3.4 Simulated oral time/temperature treatment of specimens formed in
completely closed moulds. 7
6.3.5 Order of conducting tests . 7
6.3.6 Test schedules timing . 7
6.3.7 Pass/fail determinations . 7
6.3.8 Expression of test results . 7
7 Test methods . 8
7.1 Working time test (alginate materials only) . 8
7.2 Initial setting time test (alginate impression materials only) . 9
7.2.1 Apparatus . 9
7.2.2 Specimen preparation . 9
7.2.3 Test procedure . 9
7.2.4 Pass/fail determinations and expression of results . 9
7.3 Detail reproduction test before and after specimen disinfection . 9
7.3.1 Apparatus and materials . 9
7.3.2 Examination and conditioning of equipment and accessories .10
7.3.3 Specimen preparation .10
7.3.4 Test procedure steps .12
7.3.5 Pass/fail determination and expression of results.12
7.4 Compatibility with gypsum test .12
7.4.1 Apparatus and materials .12
7.4.2 Specimen preparation .13
7.4.3 Test procedure .13
7.4.4 Pass/fail determination and expression of results.13
7.5 Elastic recovery test.13
7.5.1 Apparatus and materials .13
7.5.2 Specimen preparation .14
7.5.3 Test procedure .15
7.5.4 Calculation of results .15
7.5.5 Pass/fail determinations and expression of results .15
7.6 Strain-in-compression test .16
7.6.1 Apparatus and materials .16
7.6.2 Specimen preparation .16
7.6.3 Test procedure .16
7.6.4 Calculation of results .16
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7.6.5 Pass/fail determinations and expression of results .17
7.7 Tear strength test .17
7.7.1 Apparatus and materials .17
7.7.2 Specimen preparation .18
7.7.3 Test procedure .19
7.7.4 Calculation of results .19
7.7.5 Pass/fail determinations and expression of results .19
7.8 Linear dimensional change test (Type 3A agar materials with companion alginate only) 19
7.8.1 Apparatus and materials .19
7.8.2 Specimen preparation .20
7.8.3 Test procedure .20
7.8.4 Calculation of results .21
7.8.5 Pass and fail determinations and expression of results .21
7.9 Tensile bond strength test (Type 3A agar/companion alginate material specimen only) .21
7.9.1 Apparatus .21
7.9.2 Specimen preparation .21
7.9.3 Specimen preparation steps .22
7.9.4 Test procedure steps .22
7.9.5 Calculation of results .23
7.9.6 Pass/fail determination and expression of results.23
8 Requirements — Labelling and instructions for use .23
8.1 Labelling .23
8.2 Requirements — Instructions for use .24
8.2.1 For all hydrocolloid impression materials covered by this International
Standard — Agar and alginate .24
8.2.2 Additional instructions for agar hydrocolloid impression materials only .24
8.2.3 Additional instructions for alginate hydrocolloid materials only .25
Annex A (normative) Figures illustrating instruments and accessories used in tests .26
Annex B (informative) Tear test specimen preparation steps for an optional gripping method .39
Bibliography .44
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oSIST prEN ISO 21563:2020
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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 21563 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This second edition cancels and replaces the first edition, which has been technically revised. The
following changes were made:
— The detail reproduction before and after disinfection for alginate powder and paste/paste materials
was corrected to be 50 microns.
— The elastic recovery test was modified to allow for the use of poly(methyl methacrylate) plates as
an alternative to glass or metal.
— Figures A.2, A.3, A.4, and A.6 were corrected and multiple editorial changes were made throughout
the document.
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Introduction
Parties seeking clarification of any provisions of this International Standard, or desiring to recommend
improvements for the next edition, are encouraged to do so by contacting ISO/TC 106, Dentistry, whose
address can be obtained through inquiry to the national standards body representing the interests of
the inquiring parties.
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oSIST prEN ISO 21563:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 21563:2020(E)
Dentistry — Hydrocolloid impression materials
1 Scope
This document specifies the requirements and tests for helping determine whether the elastic aqueous
agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the
quality needed for their intended purposes. It also specifies requirements for labelling and instructions
for use.
NOTE This document specifies no requirements or tests for freedom from unacceptable biological hazards.
However, it is recommended that, to address possible biological hazards associated with the use of hydrocolloid
impression materials, interested parties should refer to ISO 7405 and ISO 10993.
2 Normative references
The following referenced documents are indispensable for 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, Dentistry — Vocabulary
ISO 6873, Dentistry — Gypsum products
ISO 3696, Water for analytical laboratory use — Specification and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
bonding
adherence of the reversible and non-reversible impression material components constituting a single
impression after each of the separate but interfacing materials has reached the level of elasticity and
effective setting required for successful removal from the mouth
3.2
bulk container
labelled consumer packaging or primary packaging container holding a greater amount of otherwise
unpackaged granular, liquid, powder, or other loose substance than is usually needed for a single dental
clinical or laboratory procedure
3.3
combined reversible/non-reversible impression material system
system of impression making in which a light bodied agar material is first syringed around selected
teeth so that it can bond with the non-reversible alginate material that will be forced over it later during
the formation of an impression
3.4
consumer packaging
retail packaging
sales packaging
packaging constituting, with its contents, a sales unit to the final user or consumer at the point of retail
[SOURCE: ISO 21067:2007, definition 2.2.5]
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3.5
elastic recovery
elastic properties required to recover adequately from deformation
3.6
extrusion temperature
temperature at which a liquefied Type 3 or Type 3A agar impression material is extruded from the
containing cartridge or syringe onto any oral cavity tissue
3.7
impression
negative copy of oral or craniofacial tissue surfaces obtained by impressing a mouldable impression
material, usually contained in an impression tray, or injected into contact with the tissue surfaces, and
allowing it to harden, or to become elastic, such that the entire impression material/tray assembly can
be removed from the contact without significant harm to the tissues or to the assembly
Note 1 to entry: A properly formed impression is capable of having a relatively fluid model (cast) forming material
poured against the intaglio surface so that, when the modelling material sets, a positive copy of the impressed
surfaces is formed.
3.8
initial setting time
time, measured from commencement of mixing components of a material, or otherwise activating the
chemistry involved, and ending at a time when results of a prescribed test show that the activated
material has begun to set at a rate 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 they can be helpful:
— in determining whether quality of a product has deteriorated before or after opening of the packaging; for
example, if the initial setting time found by the test operator or user corresponds closely to that stated in the
manufacturer’s instructions, it can be assumed that the product is of a quality suitable for testing or use;
— in the development of standards for certain materials when there is a need for a standard to identify a
reference point in time that can be used as a basis for specifying a later point in time at which a subsequently
specified procedure can safely begin.
EXAMPLE It is reasonable to expect that the effective setting times for certain types of gypsum product
mixtures will have been reached within 45 min after the initial setting times previously recorded for the mixes.
3.9
liquefaction
process of heating an agar impression or duplicating material to change it from the elastic gel state to
the mouldable or pourable sol state
3.10
non-reversible impression material
any impression material which, having been brought to the effective setting stage as required for
removal from the mouth, cannot be returned to the mouldable state required for forming impressions
3.11
primary packaging
primary container
immediate container (deprecated)
packaging designed to be in direct contact with the product
Note 1 to entry: Adapted from ISO 21067:2007, definition 2.2.2.
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3.12
reversible impression material
impression material such as an agar hydrocolloid which, after having been brought to the gel state for
marketing purposes, can be heated so as to bring it to the relatively fluid colloid or paste-like state
required for making an impression
Note 1 to entry: Whereas in past years the “gel to sol” and “sol to gel” reversibility capacities of such impression
materials has allowed them to be recycled for repeated uses, modern infection control practices now discourage
user recycling of the reversible impression materials for repeated uses in the mouth.
3.13
secondary packaging
over packaging (deprecated)
packaging designed to contain one or more primary packagings together with any protective materials,
accessory devices that may have to be provided for use with the product
Note 1 to entry: Adapted from ISO 21067:2007, definition 2.2.3.
3.14
storing
process of holding increments of liquefied reversible agar hydrocolloid impression material at a reduced
temperature pending time they will be injected or tempered for impression making purposes
3.15
strain in compression
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
3.16
tempering
process of holding a heavy or medium bodied agar impression material in a slightly higher than mouth
temperature water bath, after the material has been placed into an impression tray, so as to further
reduce the sol state temperature as necessary for safe and effective seating in the mouth
3.17
unit packet
packaging containing only the amount of product usually needed for a single dental clinical or laboratory
application
4 Classification of agar hydrocolloid impression materials
The agar impression materials are classified according to the consistencies they exhibit while they are
ready for impressing against the oral or craniofacial tissue surfaces, and when tested according to 5.1.
Type 1 Heavy bodied, for making impressions of complete or partial dental arches, with or without
the use of companion increments of lighter bodied Type 2 or Type 3 agar impression materials.
Type 2 Medium bodied, for making impressions of complete and partial dental arches, with or without
the use of companion syringe-extruded increments of Type 3 agar materials.
Type 3 Light bodied, for syringe use with either the Type 1 or Type 2 agar materials.
Type 3A Light bodied, material formulated for syringe use in a reversible/non-reversible impression
material system, and that has been claimed to be capable of bonding to a companion alginate impression
material that will make up the greater part of an agar/alginate impression material system.
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5 Requirements — Characteristics and properties
The requirements applicable to only one category of hydrocolloid impression materials (agar or
alginate) are stated immediately below in 5.1 to 5.5. The requirements applicable to both categories are
displayed in Table 1 which constitutes a part of Clause 5.
5.1 Consistency (agar impression materials of all Types, in the sol state only)
After being exposed to the recommended storing temperature treatment recommended in the
manufacturer’s instructions, the material shall have a consistency that will allow the entire content of
the tube or syringes to be extruded within 30 s. No specimens need to be made but material shall be
tested to see if all can be extruded within 30s.
5.2 Working time (alginate materials only)
When tested in accordance with 7.1, the thickness of the layer of material remaining between the tip of
the test penetrator and the test base plate shall not exceed 0,25 mm.
5.3 Initial setting time (alginate materials only)
When tested in accordance with 7.2, the initial setting time shall be within 20 % of that stated in the
manufacturer’s instructions [8.2.3 h)]
5.4 Linear dimensional change (Type 3A agar materials only)
When tested in accordance with 7.8, the dimensional change shall not exceed 1,0 %
5.5 Tensile bond strength (Type 3A agar materials only)
When tested in accordance with 7.9, the minimum tensile bond strength shall not be less than 50 kPa
Table 1 — Other requirements for properties — Agar and alginate materials
Agar materials
Test Alginate powder
subclause Test procedure and paste/paste
Type 1 and Type 3 and
number materials
Type 2 Type 3A
7.3 Detail reproduction before and after disin- 20 20 50
fection
Line width reproduced (µm)
7.4 Compatibility with gypsum 50 50 50
Line width reproduced (µm)
7.5 Elastic recovery 96,5 96,5 95,0
% (min.)
7.6 Strain-in-compression 4,0 to 15,0 4,0 to 15,0 5,0 to 20,0
% Range: min. to max.
7.7 Tear strength 0,75 0,50 0,38
N/mm (min.)
6 Pre-test planning approaches
The information included 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.
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