SIST EN ISO 4823:2021
(Main)Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
This document specifies the requirements and their test methods for elastomeric impression and bite
registration materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment
of these hazards is addressed in ISO 7405 and the ISO 10993 series.
Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO 4823:2021)
Dieses Dokument spezifiziert die Anforderungen und ihre Prüfverfahren für elastomere Abformmaterialien und Bissregistriermassen.
ANMERKUNG Dieses Dokument geht nicht auf mögliche biologische Gefahren ein, die mit den Materialien in Zusammenhang stehen. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405 und ISO 10993 heranzuziehen.
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement des rapports intermaxillaires à base d’élastomères (ISO 4823:2021)
Le présent document spécifie les exigences relatives aux produits pour empreintes et aux matériaux pour enregistrement des rapports intermaxillaires à base d'élastomères ainsi que les méthodes d'essai correspondantes.
NOTE Le présent document ne traite pas des dangers biologiques éventuellement associés aux matériaux. L'évaluation de ces dangers est traitée dans l'ISO 7405 et dans la série de normes ISO 10993.
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 4823:2021
01-junij-2021
Nadomešča:
SIST EN ISO 4823:2015
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO
4823:2021)
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement
des rapports intermaxillaires à base d’élastomères (ISO 4823:2021)
Ta slovenski standard je istoveten z: EN ISO 4823:2021
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 4823:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 4823:2021
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SIST EN ISO 4823:2021
EN ISO 4823
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2021
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 4823:2015
English Version
Dentistry - Elastomeric impression and bite registration
materials (ISO 4823:2021)
Médecine bucco-dentaire - Produits pour empreintes et Zahnheilkunde - Elastomere Abformmaterialien und
matériaux pour enregistrement des rapports Bissregistriermassen (ISO 4823:2021)
intermaxillaires à base d'élastomères (ISO 4823:2021)
This European Standard was approved by CEN on 17 March 2021.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4823:2021 E
worldwide for CEN national Members.
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SIST EN ISO 4823:2021
EN ISO 4823:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 4823:2021
EN ISO 4823:2021 (E)
European foreword
This document (EN ISO 4823:2021) has been prepared by Technical Committee ISO/TC 106 "Dentistry"
in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by
DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2021, and conflicting national standards
shall be withdrawn at the latest by September 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4823:2015.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 4823:2021 has been approved by CEN as EN ISO 4823:2021 without any modification.
3
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SIST EN ISO 4823:2021
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SIST EN ISO 4823:2021
INTERNATIONAL ISO
STANDARD 4823
Fifth edition
2021-02
Dentistry — Elastomeric impression
and bite registration materials
Médecine bucco-dentaire — Produits pour empreintes et matériaux
pour enregistrement des rapports intermaxillaires à base
d’élastomères
Reference number
ISO 4823:2021(E)
©
ISO 2021
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SIST EN ISO 4823:2021
ISO 4823:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 4823:2021
ISO 4823:2021(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 Packaging requirements . 3
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 the manufacturer's instructions . 4
5.3.1 General. 4
5.3.2 Identifying information . . 4
5.3.3 Specific instructions for use . 4
5.4 Requirements for characteristics and properties . 5
5.4.1 Component colours (hand-spatulated or hand-kneaded mixes) . 5
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 5
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
5.4.10 Minimum time in the oral cavity for bite registration materials . 6
5.4.11 Compression set of bite registration materials . 6
5.4.12 Hardness of bite registration materials . 6
6 Pre-test planning approaches . 6
6.1 Sampling . 6
6.2 Pre-test product examinations . 7
6.2.1 Examinations for compliance with labelling requirements . 7
6.2.2 Examinations for effectiveness of the packaging . 7
6.2.3 Examinations for compliance with requirements for instructions for use . 7
6.3 Essential pre-test preparatory practices . 7
6.3.1 Laboratory conditions . 7
6.3.2 Apparatus function verification steps . 8
6.3.3 Volume of materials to be mixed for each specimen . 8
6.3.4 Standardized approaches to proportioning, mixing, and handling of hand
mixed materials to be tested. 8
6.3.5 Timing for the specimen preparation and test procedures . 8
6.3.6 Simulated oral time/temperature treatment of specimens formed in
completely closed mould assemblies . 8
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) . 9
7.1.3 Pass/fail determination and expression of results. 9
7.2 Consistency . 9
7.2.1 Apparatus and materials . 9
7.2.2 Advance preparation steps. 9
© ISO 2021 – All rights reserved iii
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SIST EN ISO 4823:2021
ISO 4823:2021(E)
7.2.3 Specimen preparation and test procedure (5 specimens) .10
7.2.4 Pass/fail determination and expression of results.10
7.3 Working-time .10
7.3.1 Apparatus .10
7.3.2 Working time test .11
7.4 Detail reproduction .12
7.4.1 Apparatus and materials .12
7.4.2 Specimen preparation .12
7.4.3 Test procedure .13
7.4.4 Pass/fail determination and expression of results.13
7.5 Linear dimensional change .13
7.5.1 Apparatus and materials .13
7.5.2 Test block line-length measurement procedure .14
7.5.3 Specimen preparation .14
7.5.4 Test specimen measurement .14
7.6 Compatibility with gypsum .15
7.6.1 Apparatus and materials .15
7.6.2 Specimen preparation .16
7.6.3 Test procedure .16
7.6.4 Pass/fail determination and expression of results.16
7.7 Elastic recovery .17
7.7.1 Apparatus and materials .17
7.7.2 Specimen preparation .17
7.7.3 Test procedure .18
7.7.4 Calculation of results .18
7.7.5 Pass/fail determination and expression of results.18
7.8 Strain in compression .18
7.8.1 Apparatus .18
7.8.2 Specimen preparation .19
7.8.3 Test procedure .19
7.8.4 Calculation of results .19
7.8.5 Pass/fail determination and expression of results.19
7.9 Minimum time in the oral cavity and compression set for bite registration materials .19
7.9.1 Apparatus .19
7.9.2 Specimen preparation .19
7.9.3 Test procedure .19
7.9.4 Evaluation .20
7.9.5 Pass/fail determination and expression of results.20
7.10 Hardness of bite registration materials .20
7.10.1 Apparatus .20
7.10.2 Specimen preparation .20
7.10.3 Test procedure .20
7.10.4 Evaluation .21
7.10.5 Pass/fail determination and expression of results.21
Annex A (normative) Figures .22
Annex B (normative) Standardized hand mixing methods .30
Bibliography .33
iv © ISO 2021 – All rights reserved
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SIST EN ISO 4823:2021
ISO 4823:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 4823:2015), which has been technically
revised and enhanced with regard to elastomeric bite registration materials. The following changes
have been applied:
— the title and scope have been changed to reflect the inclusion of elastomeric bite registration
materials;
— ISO 48-4:2018 has been added as a normative reference;
— a description of minimum time in the oral cavity for bite registration materials has been added;
— a description of hardness of bite registration materials has been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 4823:2021
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SIST EN ISO 4823:2021
INTERNATIONAL STANDARD ISO 4823:2021(E)
Dentistry — Elastomeric impression and bite registration
materials
1 Scope
This document specifies the requirements and their test methods for elastomeric impression and bite
registration materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment
of these hazards is addressed in ISO 7405 and the ISO 10993 series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 48-4:2018, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation
hardness by durometer method (Shore hardness)
ISO 1942, Dentistry — Vocabulary
ISO 6873:2013, 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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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
3.2
elastic recovery
elastic properties required to recover adequately after deformation
3.3
extrusion mixing
method by which two or more material components are extruded simultaneously from their separate
primary containers through a mixing nozzle 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
© ISO 2021 – All rights reserved 1
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SIST EN ISO 4823:2021
ISO 4823:2021(E)
3.5
hardness
resistance to indentation
Note 1 to entry: In this document, it is Shore hardness according to ISO 48-4:2018, Type A.
[SOURCE: ISO 1382:2020, 3.247, modified – Note 1 to entry added.]
3.6
minimum time in the oral cavity
minimum time span the material stays in the oral cavity to sufficiently minimize deformation
3.7
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.
3.8
outer package
wrapping or carton, used to cover one or more primary containers in preparation for retail marketing
Note 1 to entry: Legislation or specific standards can apply.
3.9
primary packaging
container designed to come into direct contact with the product
[SOURCE: ISO 21067-1:2016, 2.2.3, modified — “packaging” replaced with “container” in the definition.]
3.10
strain in compression
flexibility/stiffness property ranges of the materials that determines whether the set materials, when
formed as impressions, can be removed from the mouth without injury to the impressed oral tissues
and have adequate stiffness in the more flexible portions of impressions to resist deformation when
model-forming products are poured against them
3.11
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 prevents the material from being manipulated as required
to form an impression or a mould having the desired surface detail and dimensional characteristics
4 Classificatio
...
SLOVENSKI STANDARD
oSIST prEN ISO 4823:2020
01-julij-2020
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO/DIS 4823:2020)
Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2020)
Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO/DIS
4823:2020)
Ta slovenski standard je istoveten z: prEN ISO 4823
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 4823:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 4823:2020
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oSIST prEN ISO 4823:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 4823
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-23 2020-07-16
Dentistry — Elastomeric impression and bite registration
materials
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 4823:2020(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
---------------------- Page: 3 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(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
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(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 .3
5.1 Packaging requirements . 3
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 . . 4
5.3.3 Specific instructions for use . 4
5.4 Requirements for characteristics and properties . 5
5.4.1 Component colours (hand-spatulated or hand-kneaded mixes) . 5
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 5
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
5.4.10 Minimum time in the oral cavity for bite registration materials . 5
5.4.11 Compression set of bite registration materials . 5
5.4.12 Hardness of bite registration materials . 6
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 . 7
6.2.2 Examinations for effectiveness of the packaging . 7
6.2.3 Examinations for compliance with requirements for instructions for use . 7
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 . 8
6.3.4 Order for conducting examinations and tests . 8
6.3.5 Standardized approaches to proportioning, mixing, and handling of hand
mixed materials to be tested. 8
6.3.6 Timing for the specimen preparation and test procedures . 8
6.3.7 Simulated oral time/temperature treatment of specimens formed in
completely closed mould assemblies . 8
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) . 9
7.1.3 Pass/fail determination and expression of results. 9
7.2 Consistency . 9
7.2.1 Apparatus and materials . 9
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(E)
7.2.2 Advance preparation steps. 9
7.2.3 Specimen preparation and test procedure (5 specimens) .10
7.2.4 Pass/fail determination and expression of results.10
7.3 Working-time .10
7.3.1 Apparatus .10
7.3.2 Working time test .11
7.4 Detail reproduction .12
7.4.1 Apparatus and materials .12
7.4.2 Specimen preparation .12
7.4.3 Test procedure .13
7.4.4 Pass/fail determination and expression of results.13
7.5 Linear dimensional change .13
7.5.1 Apparatus and materials .13
7.5.2 Test block line-length measurement procedure .14
7.5.3 Specimen preparation .14
7.5.4 Test specimen measurement .14
7.6 Compatibility with gypsum .15
7.6.1 Apparatus and materials .15
7.6.2 Specimen preparation .16
7.6.3 Test procedure .16
7.6.4 Pass/fail determination and expression of results.16
7.7 Elastic recovery .16
7.7.1 Apparatus and materials .16
7.7.2 Specimen preparation .17
7.7.3 Test procedure .18
7.7.4 Calculation of results .18
7.7.5 Pass/fail determination and expression of results.18
7.8 Strain in compression .18
7.8.1 Apparatus .18
7.8.2 Specimen preparation .18
7.8.3 Test procedure .19
7.8.4 Calculation of results .19
7.8.5 Pass/fail determination and expression of results.19
7.9 Minimum time in the oral cavity and compression set for bite registration materials .19
7.9.1 Apparatus .19
7.9.2 Preparation of test specimens .19
7.9.3 Test procedure .19
7.9.4 Evaluation .20
7.9.5 Pass/fail determination and expression of results.20
7.10 Hardness of bite registration materials .20
7.10.1 Apparatus .20
7.10.2 Preparation of test specimens .20
7.10.3 Procedure (according to ISO 48-4:2018).20
7.10.4 Evaluation .21
7.10.5 Pass/fail determination and expression of results.21
Annex A (normative) Figures cited in this International Standard .22
Annex B (normative) Standardized hand mixing methods .31
Bibliography .34
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 4823:2020
ISO/DIS 4823:2020(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 fifth edition cancels and replaces the fourth edition (ISO 4823:2015), which has been technically
revised and enhanced with regard to elastomeric bite registration materials. The following changes
have been applied:
— title and scope changed to reflect inclusion of elastomeric bite registration materials;
— added ISO 48-4:2018 as a normative reference;
— added description of minimum time in the oral cavity for bite registration materials;
— added description of hardness of bite registration materials.
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 4823:2020
---------------------- Page: 8 ----------------------
oSIST prEN ISO 4823:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 4823:2020(E)
Dentistry — Elastomeric impression and bite registration
materials
1 Scope
This document specifies the requirements and their test methods for elastomeric impression and bite
registration materials.
NOTE This document 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 are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 48-4:2018, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation
hardness by durometer method (Shore hardness)
ISO 1942, Dentistry — Vocabulary
ISO 6873:2013, 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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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
3.2
elastic recovery
elastic properties required to recover adequately after deformation
3.3
extrusion mixing
method by which two or more material components are extruded simultaneously from their separate
primary containers through a mixing nozzle 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
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3.5
hardness
Shore hardness according to ISO 48-4:2018 Type A
3.6
minimum time in the oral cavity
minimum time span the material has to stay in the oral cavity before removal to sufficiently minimize
deformation
3.7
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.
3.8
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
3.9
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.]
3.10
strain in compression
〈elastic impression materials〉 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
3.11
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;
— Type B: bite registration materials.
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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.
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
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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).
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;
...
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