Dentistry — Elastomeric impression and bite registration materials

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.

Médecine bucco-dentaire — Produits pour empreintes et matériaux pour enregistrement des rapports intermaxillaires à base d’élastomères

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.

General Information

Status
Published
Publication Date
24-Feb-2021
Current Stage
6060 - International Standard published
Start Date
25-Feb-2021
Completion Date
25-Feb-2021
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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
---------------------- Page: 1 ----------------------
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
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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: 2 ----------------------
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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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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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
---------------------- Page: 5 ----------------------
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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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 Classification

Materials covered by this document 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.
2 © ISO 2021 – All rights reserved
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ISO 4823:2021(E)
5 Requirements
5.1 Packaging requirements

No packaging requirements are specified in this document, but it is important for manufacturers to take

into account that the packaging should be such that it does 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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
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 can 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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
© ISO 2021 – All rights reserved 3
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ISO 4823:2021(E)
5.3 Requirements for information in the 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.

NOTE Additional information to that specified in 5.3.2 and 5.3.3 can be supplied at the discretion of the

manufacturer or as required by regulation.
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 applicable:
— room temperature variations;
— variations in the speed and friction involved in mixing;
— hand/fingertip temperatures when kneading putty mixes;
— moisture contamination or relative humidity;

— contamination, either due to direct contact with latex dam or gloves used in clinical practice or

due to the presence of such contaminants on teeth at the time they are impressed;

c) proportions for hand-spatulated mixes (mass to mass and volume to volume);

d) recommended mixing apparatus and procedures to include the generic identification of any hand

coverings (gloves or polymer sheeting) that should be used to avoid contamination of the materials

during hand manipulation;

e) mixing time required to obtain a homogeneous mixture of an amount of the material having a

volume of 15 ml [see 5.3.3, d) and Annex B];
f) working time;
g) minim
...

NORME ISO
INTERNATIONALE 4823
Cinquième édition
2021-02
Médecine bucco-dentaire — Produits
pour empreintes et matériaux
pour enregistrement des rapports
intermaxillaires à base d’élastomères
Dentistry — Elastomeric impression and bite registration materials
Numéro de référence
ISO 4823:2021(F)
ISO 2021
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ISO 4823:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

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être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

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Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 4823:2021(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 2

5 Exigences ...................................................................................................................................................................................................................... 3

5.1 Exigences relatives à l’emballage ............................................................................................................................................ 3

5.2 Exigences relatives à l’étiquetage ........................................................................................................................................... 3

5.2.1 Emballage extérieur (comportant un ou plusieurs contenants primaires) .................. 3

5.2.2 Contenants primaires contenus dans des emballages extérieurs ......................................... 3

5.3 Exigences relatives aux informations à fournir dans les instructions du fabricant .................... 4

5.3.1 Généralités ............................................................................................................................................................................ 4

5.3.2 Informations d’identification ................................................................................................................................ 4

5.3.3 Instructions particulières d’utilisation ......................................................................................................... 4

5.4 Exigences relatives aux propriétés et aux caractéristiques ............................................................................. 5

5.4.1 Couleurs des composants (mélanges malaxés manuellement ou spatulés

manuellement) .................................................................................................................................................................. 5

5.4.2 Temps de mélange (mélanges malaxés manuellement ou spatulés

manuellement) .................................................................................................................................................................. 5

5.4.3 Consistance ........................................................................................................................................................................... 5

5.4.4 Temps de travail ............................................................................................................................................................... 5

5.4.5 Reproduction des détails .......................................................................................................................................... 5

5.4.6 Variation dimensionnelle linéaire ..................................................................................................................... 5

5.4.7 Compatibilité avec le gypse .................................................................................................................................... 5

5.4.8 Recouvrance élastique ................................................................................................................................................ 6

5.4.9 Déformation en compression ............................................................................................................................... 6

5.4.10 Temps minimal dans la cavité buccale pour les matériaux pour

enregistrement des rapports intermaxillaires ....................................................................................... 6

5.4.11 Compression rémanente des matériaux pour enregistrement des rapports

intermaxillaires ................................................................................................................................................................. 6

5.4.12 Dureté des matériaux pour enregistrement des rapports intermaxillaires ................. 6

6 Approches de planification préalables aux essais ............................................................................................................ 6

6.1 Échantillonnage ...................................................................................................................................................................................... 7

6.2 Contrôles du produit avant les essais .................................................................................................................................. 7

6.2.1 Contrôles de la conformité aux exigences relatives à l’étiquetage ....................................... 7

6.2.2 Contrôles de l’efficacité de l’emballage ........................................................................................................ 7

6.2.3 Contrôles de la conformité aux exigences relatives aux instructions d’utilisation 7

6.3 Pratiques préparatoires essentielles avant les essais ........................................................................................... 8

6.3.1 Conditions de laboratoire......................................................................................................................................... 8

6.3.2 Étapes de vérification du fonctionnement de l’appareillage ..................................................... 8

6.3.3 Volume de matériaux à mélanger pour chaque éprouvette ........................................................ 8

6.3.4 Approches normalisées pour doser, mélanger et manipuler les matériaux

à soumettre à essai mélangés manuellement ......................................................................................... 8

6.3.5 Détermination du temps de préparation des éprouvettes et des modes

opératoires d’essai ......................................................................................................................................................... 8

6.3.6 Traitement simulé de la température buccale et du temps d’application en
bouche pour les éprouvettes réalisées dans des assemblages de moules

complètement fermés .................................................................................................................................................. 8

6.4 Détermination de la réussite ou de l’échec ..................................................................................................................... 8

6.5 Expression des résultats d’essai .............................................................................................................................................. 9

7 Méthodes d’essai — Spécifiques........................................................................................................................................................... 9

7.1 Temps de mélange ............................................................................................................................................................................... 9

© ISO 2021 – Tous droits réservés iii
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ISO 4823:2021(F)

7.1.1 Appareillage ......................................................................................................................................................................... 9

7.1.2 Préparation des éprouvettes et mode opératoire d’essai (cinq éprouvettes) ............. 9

7.1.3 Détermination de la réussite ou de l’échec et expression des résultats .......................... 9

7.2 Consistance ................................................................................................................................................................................................ 9

7.2.1 Appareillage et matériaux........................................................................................................................................ 9

7.2.2 Étapes préliminaires de préparation ..........................................................................................................10

7.2.3 Préparation des éprouvettes et mode opératoire d’essai (5 éprouvettes) .................10

7.2.4 Détermination de la réussite ou de l’échec et expression des résultats .......................10

7.3 Temps de travail ..................................................................................................................................................................................11

7.3.1 Appareillage ......................................................................................................................................................................11

7.3.2 Essai du temps de travail .......................................................................................................................................11

7.4 Reproduction des détails .............................................................................................................................................................13

7.4.1 Appareillage et matériaux.....................................................................................................................................13

7.4.2 Préparation des éprouvettes ..............................................................................................................................13

7.4.3 Mode opératoire d’essai .........................................................................................................................................14

7.4.4 Détermination de la réussite ou de l’échec et expression des résultats .......................14

7.5 Variation dimensionnelle linéaire .......................................................................................................................................14

7.5.1 Appareillage et matériaux.....................................................................................................................................14

7.5.2 Mode opératoire de mesurage de la longueur des lignes du bloc d’essai ....................14

7.5.3 Préparation des éprouvettes ..............................................................................................................................15

7.5.4 Mesurage des éprouvettes ....................................................................................................................................15

7.6 Compatibilité avec le gypse .......................................................................................................................................................16

7.6.1 Appareillage et matériaux.....................................................................................................................................16

7.6.2 Préparation des éprouvettes ..............................................................................................................................17

7.6.3 Mode opératoire d’essai .........................................................................................................................................17

7.6.4 Détermination de la réussite ou de l’échec et expression des résultats .......................17

7.7 Recouvrance élastique ...................................................................................................................................................................17

7.7.1 Appareillage et matériaux.....................................................................................................................................17

7.7.2 Préparation des éprouvettes ..............................................................................................................................18

7.7.3 Mode opératoire d’essai .........................................................................................................................................19

7.7.4 Calcul des résultats .....................................................................................................................................................19

7.7.5 Détermination de la réussite ou de l’échec et expression des résultats .......................19

7.8 Déformation en compression ..................................................................................................................................................19

7.8.1 Appareillage ......................................................................................................................................................................19

7.8.2 Préparation des éprouvettes ..............................................................................................................................20

7.8.3 Mode opératoire d’essai .........................................................................................................................................20

7.8.4 Calcul des résultats .....................................................................................................................................................20

7.8.5 Détermination de la réussite ou de l’échec et expression des résultats .......................20

7.9 Temps minimal dans la cavité buccale et compression rémanente des matériaux

pour enregistrement des rapports intermaxillaires ............................................................................................20

7.9.1 Appareillage ......................................................................................................................................................................20

7.9.2 Préparation des éprouvettes ..............................................................................................................................21

7.9.3 Mode opératoire d’essai .........................................................................................................................................21

7.9.4 Évaluation ...........................................................................................................................................................................21

7.9.5 Détermination de la réussite ou de l’échec et expression des résultats .......................21

7.10 Dureté des matériaux pour enregistrement des rapports intermaxillaires ....................................21

7.10.1 Appareillage ......................................................................................................................................................................21

7.10.2 Préparation des éprouvettes ..............................................................................................................................21

7.10.3 Mode opératoire d’essai .........................................................................................................................................22

7.10.4 Évaluation ...........................................................................................................................................................................22

7.10.5 Détermination de la réussite ou de l’échec et expression des résultats .......................22

Annexe A (normative) Figures .................................................................................................................................................................................23

Annexe B (normative) Méthodes normalisées de mélange manuel .................................................................................31

Bibliographie ...........................................................................................................................................................................................................................35

iv © ISO 2021 – Tous droits réservés
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ISO 4823:2021(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d’approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de

droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant -propos.

Le présent document a été élaboré par le Comité technique ISO/ISO/TC 106, Médecine bucco-dentaire,

sous-comité SC 2, Produits pour prothèses dentaires, en collaboration avec le Comité européen de

normalisation (CEN), Comité technique CEN/TC 55, Médecine bucco-dentaire, conformément à l’Accord

de coopération technique entre l’ISO et le CEN (Accord de Vienne).

Cette cinquième édition annule et remplace la quatrième édition (ISO 4823:2015), qui a fait l’objet d’une

révision technique et a été complétée de façon à inclure les matériaux pour enregistrement des rapports

intermaxillaires à base d’élastomères. Les modifications suivantes ont été apportées:

— modification du titre et du domaine d’application pour tenir compte de l’ajout des matériaux pour

enregistrement des rapports intermaxillaires à base d’élastomères;
— ajout de la norme ISO 48-4:2018 aux références normatives;

— ajout de la description relative au temps minimal dans la cavité buccale pour les matériaux pour

enregistrement des rapports intermaxillaires;

— ajout de la description relative à la dureté des matériaux pour enregistrement des rapports

intermaxillaires.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2021 – Tous droits réservés v
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NORME INTERNATIONALE ISO 4823:2021(F)
Médecine bucco-dentaire — Produits pour empreintes
et matériaux pour enregistrement des rapports
intermaxillaires à base d’élastomères
1 Domaine d’application

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.

2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).

ISO 48-4:2018, Caoutchouc vulcanisé ou thermoplastique — Détermination de la dureté — Partie 4: Dureté

par pénétration par la méthode au duromètre (dureté Shore)
ISO 1942, Médecine bucco-dentaire — Vocabulaire
ISO 6873:2013, Médecine bucco-dentaire — Produits à base de gypse
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions de l’ISO 1942 ainsi que les suivants,

s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/ .
3.1
consistance

degré de fermeté auquel les particules d’un matériau prêt à être utilisé s’agglomèrent afin de permettre

le fluage du matériau, ou la résistance au fluage
3.2
recouvrance élastique

propriétés d’élasticité requises pour reprendre une forme adéquate après déformation

3.3
mélange par extrusion

méthode par laquelle deux composants ou plus d’un matériau sont extrudés simultanément de leurs

contenants primaires séparés, au moyen d’une buse de mélange permettant d’obtenir un mélange

homogène
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ISO 4823:2021(F)
3.4
mélange manuel

méthode de mélange des composants d’un matériau par malaxage manuel ou au moyen d’une spatule

3.5
dureté
résistance à l’indentation

Note 1 à l'article: Dans le présent document, il s’agit de la dureté Shore selon l’ISO 48-4:2018, Type A.

[SOURCE: ISO 1382:2020, 3.247, modifiée — Note 1 à l’article ajoutée.]
3.6
temps minimal dans la cavité buccale

laps de temps minimal pendant lequel le matériau reste dans la cavité buccale afin de réduire

suffisamment sa déformation
3.7
temps de mélange

temps requis, mesuré à partir du premier contact entre les différents composants du matériau à

mélanger, pour obtenir un mélange homogène lorsque ces composants sont mélangés conformément

aux instructions du fabricant

Note 1 à l'article: Le moment du premier contact entre les composants du matériau mélangés par extrusion est

défini comme le moment où les composants du matériau entrent dans la buse de mélange.

3.8
emballage extérieur

emballage ou carton utilisé pour couvrir un ou plusieurs des contenants primaires lors de la préparation

pour la commercialisation

Note 1 à l'article: La législation ou des normes spécifiques peuvent s’appliquer.

3.9
emballage primaire
contenant destiné à venir en contact direct avec le produit

[SOURCE: ISO 21067-1:2016, 2.2.3, modifiée — « emballage » a été remplacé par « contenant » dans la

définition.]
3.10
déformation en compression

propriétés de flexibilité/rigidité des matériaux déterminant si les produits pour empreintes peuvent

être retirés de la bouche sans léser les tissus buccaux concernés après leur prise, et s’ils ont une rigidité

appropriée, au niveau des parties les plus souples de l’empreinte, pour résister à la déformation lorsque

les produits destinés à confectionner les modèles sont déposés à leur contact
3.11
temps de travail

laps de temps commençant au début du mélange et s’achevant avant que le matériau mélangé ne

commence à présenter des propriétés élastiques qui l’empêchent d’être manipulé comme requis

pour former une empreinte ou un moule ayant les caractéristiques de détail de la surface et les

caractéristiques dimensionnelles souhaitées
4 Classification

Les matériaux couverts par le présent document sont classés selon les consistances suivantes

déterminées immédiatement après le mélange conformément aux instructions du fabricant (voir 5.3):

— type 0: très haute consistance;
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ISO 4823:2021(F)
— type 1: haute consistance;
— type 2: consistance moyenne;
— type 3: consistance faible;
— type B: matériaux pour enregistrement des rapports intermaxillaires.
5 Exigences
5.1 Exigences relatives à l’emballage

Le présent document ne spécifie pas d’exigences en matière d’emballage. Cependant, il est important que

les fabricants tiennent compte du fait qu’il convient que l’emballage ne contamine pas et ne permette

pas une contamination des composants du matériau dans les conditions de stockage recommandées. Il

convient également que la structure de l’emballage primaire permette d’éviter toute fuite ou extrusion

du contenu par inadvertance au cours du stockage, et tout risque de casse des contenants lors de

l’utilisation des méthodes d’extrusion recommandées par le fabricant.

NOTE Des informations supplémentaires peuvent être fournies à la discrétion du fabricant ou conformément

aux obligations réglementaires.
5.2 Exigences relatives à l’étiquetage
5.2.1 Emballage extérieur (comportant un ou plusieurs contenants primaires)

L’étiquetage de l’emballage extérieur préparé pour commercialisation comportant un ou plusieurs

contenants primaires doit comprendre les informations suivantes:
a) les conditions de stockage recommandées pour les emballages fermés;
b) la marque de fabrique du matériau;

c) le nom et l’adresse du fabricant, ou d’une autre société autorisée par le fabricant à commercialiser

le matériau sous une marque de fabrique différente;

d) l’identification de la consistance du matériau: très haute consistance, haute consistance, consistance

moyenne ou consistance faible (voir Article 4) (le numéro de type peut également être précisé);

e) la ou les références du lot de fabrication;

f) la mention « À UTILISER AVANT LE », date au-delà de laquelle le matériau risque d’être moins

performant; la date doit être exprimée par un nombre à six chiffres, par exemple 2014-09, les

quatre premiers chiffres indiquant l’année (2014) et les deux derniers chiffres le mois (septembre);

g) le volume minimal qui résultera du mélange de la totalité du contenu se trouvant dans l’emballage

extérieur.

NOTE Des informations supplémentaires peuvent être fournies à la discrétion du fabricant ou conformément

aux obligations réglementaires.
5.2.2 Contenants primaires contenus dans des emballages extérieurs

Les étiquettes des contenants primaires doivent comporter les informations suivantes:

a) la marque de fabrique du matériau;

b) le nom du fabricant, ou d’une autre société autorisée à commercialiser le matériau sous une marque

de fabrique différente;
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ISO 4823:2021(F)

c) l’identification des composants (pas exigée lorsque les composants pour le mélange par extrusion

sont fournis dans des contenants primaires séparés mais joints);
d) les références du lot de fabrication.

NOTE Des informations supplémentaires peuvent être fournies à la discrétion du fabricant ou conformément

aux obligations réglementaires.

5.3 Exigences relatives aux informations à fournir dans les instructions du fabricant

5.3.1 Généralités

Chaque emballage contenant la préparation pour commercialisation des composants d’un produit pour

empreinte doit être accompagné des instructions et des autres informations nécessaires pour obtenir

une efficacité optimale du matériau dans la pratique clinique.
NOTE Des informations supplémentaires à celles présentées e
...

INTERNATIONAL ISO
STANDARD 4823
Fifth edition
Dentistry — Elastomeric impression
and bite registration materials
Médecine bucco-dentaire — Produits pour empreintes et matériaux
pour enregistrement des rapports intermaxillaires à base
d’élastomères
PROOF/ÉPREUVE
Reference number
ISO 4823:2020(E)
ISO 2020
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ISO 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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 4823:2020(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

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ISO 4823:2020(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

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ISO 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 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 2020 – All rights reserved PROOF/ÉPREUVE v
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INTERNATIONAL STANDARD ISO 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. 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

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ISO 4823:2020(E)
3.5
hardness
resistance to indentation

Note 1 to entry: Note1 to entry: In this document, it is the 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 by “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 Classification

Materials covered by this document 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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ISO 4823:2020(E)
5 Requirements
5.1 Packaging requirements

No packaging requirements are specified in this document, but it is important for manufacturers to take

into account that the packaging should be such that it does 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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
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 can 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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
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.

NOTE Additional information can be supplied at the discretion of the manufacturer or as required by

regulation.
© ISO 2020 – All rights reserved PROOF/ÉPREUVE 3
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ISO 4823:2020(E)
5.3 Requirements for information in the 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.

NOTE Additional information to that specified in 5.3.2 and 5.3.3 can be supplied at the discretion of the

manufacturer or as required by regulation.
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 applicable:
— room temperature variations;
— variations in the speed and friction involved in mixing;
— hand/fingertip temperatures when kneading putty mixes;
— moisture contamination or relative humidity;

— contamination, either due to direct contact with latex dam or gloves used in clinical practice or

due to the presence of such contaminants on teeth at the time they are impressed;

c) proportions for hand-spatulated mixes (mass to mass and volume to volume);

d) recommended mixing apparatus and procedures to include the generic identification of any hand

coverings (gloves or polymer sheeting) that should be used to avoid contamination of the materials

during hand manipulation;
e) mixing time required to obtain a homogeneous mi
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