SIST EN ISO 21563:2013
(Main)Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
This International Standard 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.
Zahnheilkunde - Hydrokolloidabformmassen (ISO 21563:2013)
Die vorliegende ISO-Norm legt die Anforderungen und Prüfungen fest, mit deren Hilfe bestimmt werden kann, ob die elastischen zahnärztlichen Agar- und Alginatabformmassen auf Wasserbasis im Zustand der Einzelhandelsvermarktung über die Qualität verfügen, die für den Verwendungszweck benötigt wird.
Médecine bucco-dentaire - Matériaux d'impression hydrocolloïde (ISO 21563:2013)
L'ISO 21563:2013 spécifie les exigences et essais permettant de déterminer si les produits pour empreintes dentaires à base d'hydrocolloïde d'alginate et d'agar-agar aqueux et élastiques, tels qu'ils sont préparés pour la commercialisation au détail, présentent la qualité requise aux fins recherchées. Elle spécifie également les exigences relatives à l'étiquetage et la notice d'utilisation.
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)
Ta mednarodni standard določa zahteve in preskuse za ugotavljanje, ali hidrokoloidni materiali za dentalno oblikovanje (elastični vodni agar in alginat), kot so pripravljeni za trženje v prodaji na drobno, izpolnjujejo zahteve glede kakovosti, potrebne za njihovo predvideno uporabo. Prav tako določa zahteve za označevanje in navodila za uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21563:2013
01-november-2013
1DGRPHãþD
SIST EN 21563:2000
SIST EN ISO 13716:2001
SIST EN ISO 1564:2000
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Zahnheilkunde - Hydrokolloidabformmassen (ISO 21563:2013)
Médecine bucco-dentaire - Matériaux d'impression hydrocolloïde (ISO 21563:2013)
Ta slovenski standard je istoveten z: EN ISO 21563:2013
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 21563:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 21563:2013
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SIST EN ISO 21563:2013
EUROPEAN STANDARD
EN ISO 21563
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2013
ICS 11.060.10 Supersedes EN 21563:1991, EN ISO 13716:2000, EN
ISO 1564:1998
English Version
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Médecine bucco-dentaire - Produits pour empreintes à Zahnheilkunde - Hydrokolloidabformmassen (ISO
base d'hydrocolloïdes (ISO 21563:2013) 21563:2013)
This European Standard was approved by CEN on 22 June 2013.
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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21563:2013: E
worldwide for CEN national Members.
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SIST EN ISO 21563:2013
EN ISO 21563:2013 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 21563:2013
EN ISO 21563:2013 (E)
Foreword
This document (EN ISO 21563:2013) 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 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014.
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 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998.
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 21563:2013 has been approved by CEN as EN ISO 21563:2013 without any modification.
3
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SIST EN ISO 21563:2013
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SIST EN ISO 21563:2013
INTERNATIONAL ISO
STANDARD 21563
First edition
2013-08-15
Dentistry — Hydrocolloid impression
materials
Médecine bucco-dentaire — Produits pour empreintes à base
d’hydrocolloïdes
Reference number
ISO 21563:2013(E)
©
ISO 2013
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SIST EN ISO 21563:2013
ISO 21563:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
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SIST EN ISO 21563:2013
ISO 21563:2013(E)
Contents Page
Foreword .iv
Introduction .v
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 . 5
6.1 Sampling . 5
6.2 Pre-test product examinations . 5
6.3 Essential pre-test preparatory practices . 6
7 Test methods . 8
7.1 Working time test (alginate materials only) . 8
7.2 Initial setting time test (alginate impression materials only) . 9
7.3 Detail reproduction test before and after specimen disinfection . 9
7.4 Compatibility with gypsum test .12
7.5 Elastic recovery test.13
7.6 Strain-in-compression test .16
7.7 Tear strength test .17
7.8 Linear dimensional change test (Type 3A agar materials with companion alginate only) 19
7.9 Tensile bond strength test (Type 3A agar/companion alginate material specimen only) .21
8 Requirements — Labelling and instructions for use .23
8.1 Labelling .23
8.2 Requirements — Instructions for use .24
Annex A (normative) Figures illustrating instruments and accessories used in tests .27
Annex B (informative) Tear test specimen preparation steps for an optional gripping method .41
Bibliography .45
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SIST EN ISO 21563:2013
ISO 21563:2013(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 21563 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This first edition of ISO 21563 constitutes a consolidation of the three standards listed below and, as
such, cancels and replaces, in whole, all three of the standards listed.
— ISO 1563:1990, Dentistry — Alginate impression materials
— ISO 1564:1995, Dental aqueous impression materials based on agar
— ISO 13716:1999, Dentistry — Reversible/irreversible hydrocolloid impression materials systems
Re-evaluations of all the provisions stated in the three ISO standards to be included in the consolidation
led to the significant technical changes listed as follows.
— The alginate hydrocolloid impression materials (ISO 1563) are now required to be subject to the
same tear strength test that has been in effect for the agar hydrocolloid impression materials
(ISO 1564 and ISO 13716) instead of being subject to a compressive strength test.
— The requirement for the alginate impression material powder materials to be “free from foreign
materials”, as stated in ISO 1563, has not been carried forward into the consolidation because no
objective test has been specified for determining compliance with the requirement.
— The “gelation temperature” requirements in ISO 1564 and ISO 13716 have not been carried forward
for the agar impression materials because results of the elastic recovery test (7.5), if conducted
following the required manufacturer’s instructions for use (8.2.1 and/or 8.2.2), will indicate
whether adequate gelation will take place during clinical use of the materials.
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SIST EN ISO 21563:2013
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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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SIST EN ISO 21563:2013
INTERNATIONAL STANDARD ISO 21563:2013(E)
Dentistry — Hydrocolloid impression materials
1 Scope
This International Standard 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 International Standard 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 test
method of determining whether an elastic impression material will possess the elastic properties
required to recover optimally from deformation occurring during removal of impressions from contact
with the impressed oral or craniofacial tissues
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 test
standardized test method for determining whether elastic impression materials, when formed as
impressions, will have the
— flexibility required to permit removal of the impressions from the mouth without significant injury
to the impressed oral tissues, and
— the stiffness to resist the deforming forces possibly occurring during the pouring of a model-forming
gypsum into the impressions, or to make the material more effective for transferring implant
components and securing them in desired positions in an impression
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 5.2.
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.
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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.
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
Test Test procedure Agar materials Alginate powder
subclause 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 20
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.)
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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.
6.1 Sampling
Observe the following guidelines when procuring samples of materials for testing.
a) Procure only samples that have been packaged for retail 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 8.1c)]
c) Procure samples in minimal amounts shown below when conducting certification testing that will
require production of the several specimens needed for complete evaluation of the material.
— For agar materials, Type 1 and Type 2 — at least 30 large tubes or the equivalent.
— For agar materials, Type 3 and Type 3A – at least 150 sticks, cartridges or capsules.
— For alginate impression materials – at least 900 g.
— For alginate paste/paste materials – 5 l.
— Gypsum materials for the compatibility with gypsum test — at least 1 000 g.
NOTE The sample sizes specified in this subclause have been justified by taking into account the probable
amount to be consumed in testing for compliance with all stated requirements, and also the additional amounts
often needed for pre-test specimen preparation and testing practice.
6.2 Pre-test product examinations
These evaluations 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 labelling compliance with the provision of 8.1 before
any attempt to open a packaging component has defaced or obliterated any labelling entry information
needed for storage or use of the product. Record the name, Type, Lot number and Use by date as may be
applicable for each primary container of the material to be tested.
6.2.2 Examinations for effectiveness of the packaging
Before opening any primary container, examine it for possibilities that the quality of the content may
have been compromised since its manufacture; for example, evidence such as:
— loose tube caps or canister lids, or leakage;
— container rupture or punctures;
— shrinkage of the agar content of a container such as can be detected by sight, sound or touch.
Immediately after opening an alginate container, examine the content for lumps or granules that may be
due to faulty or compromised packaging.
Caution: Do not use any compromised materials for preparing specimens.
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6.2.3 Examinations for compliance with requirements for instructions for use
Before opening any primary container:
— examine the labels to determine whether they include any of the instructions for use information
specified in 8.2;
— locate and retain any instruction sheet that may have been provided outside the primary container.
Immediately after the first opening of a primary container for powder alginate, examine the content for
any instruction sheet that may have been placed inside the container.
6.3 Essential pre-test preparatory practices
6.3.1 Laboratory conditions
Unless otherwise specified in this document, conduct all specimen preparation and testing under
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) Perform whatever calibration steps necessary to ensure that the items comply with specifications
stated for them in this document, or in the normative supporting reference ISO 6873
c) Clear all instrumentation or equipment surfaces that will come in contact with the specimen
material of any contaminants that might influence the test result.
6.3.3 Test material handling and use
6.3.3.1 Identification of separately packaged samples
When the sample procured for testing (6.1) includes two or more separate packages, assign an
identifying numeric or alphabetical/numeric symbol to each separate primary container for the purpose
of maintaining a record of the particular container from which the materials used to form a particular
specimen was tak
...
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