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)

Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)

General Information

Status
Published
Public Enquiry End Date
14-Jul-2020
Publication Date
11-May-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Apr-2021
Due Date
07-Jun-2021
Completion Date
12-May-2021

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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

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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.

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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
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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
...

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