EN ISO 4823:2021
(Main)Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.
Zahnheilkunde - Elastomere Abform- und Bissregistriermaterialien (ISO 4823:2021)
Dieses Dokument legt die Anforderungen und ihre Prüfverfahren für elastomere Abform- und Bissregistriermaterialien fest.
ANMERKUNG Dieses Dokument geht nicht auf mögliche biologische Gefahren ein, die mit den Materialien in Zusammenhang stehen. Die Beurteilung dieser biologischen Gefahren wird in ISO 7405 und der Normenreihe ISO 10993 behandelt.
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement des rapports intermaxillaires à base d’élastomères (ISO 4823:2021)
Le présent document spécifie les exigences relatives aux produits pour empreintes et aux matériaux pour enregistrement des rapports intermaxillaires à base d'élastomères ainsi que les méthodes d'essai correspondantes.
NOTE Le présent document ne traite pas des dangers biologiques éventuellement associés aux matériaux. L'évaluation de ces dangers est traitée dans l'ISO 7405 et dans la série de normes ISO 10993.
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)
General Information
Relations
Frequently Asked Questions
EN ISO 4823:2021 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)". This standard covers: 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.
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.
EN ISO 4823:2021 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 4823:2021 has the following relationships with other standards: It is inter standard links to EN ISO 4823:2015, EN ISO 4823:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 4823:2021 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 4823:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 4823:2021(E)
© 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
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 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
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.
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 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
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 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) minimum time the material should remain in the mouth before removal.
The following items only apply to impression materials:
h) minimum or maximum time lapse, or both, permitted between removal of the impression from the
mouth and pouring the gypsum product into the impression;
i) identification of at least two gypsum products, complying with requirements of ISO 6873:2013,
which the impression material manufacturer has found to be compatible with the impression
material being tested: one Type 3 product (dental stone, model) and either one Type 4 product or
one Type 5 product (dental stone, high strength);
4 © ISO 2021 – All rights reserved
ISO 4823:2021(E)
j) when the manufacturer's instructions state that an impression made of a material may be
disinfected, the disinfecting procedure shall be described in detail and a reference indicating that
the disinfection procedure will not alter the potential of the impression for optimum performance
shall also be identified;
k) when a manufacturer claims that a material in itself is antimicrobial and will remain so without
further treatment after the impression is removed from the mouth, the manufacturer shall identify
the reference on which the claim is based.
5.4 Requirements for characteristics and properties
5.4.1 Component colours (hand-spatulated or hand-kneaded mixes)
Different components intended for use in the same mixture shall be supplied in contrasting colours to
provide a means of determining when the components have been thoroughly mixed.
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes)
When the material components are combined according to the manufacturer’s instructions and the
results of the mixing are evaluated according to 7.1, the average time required to achieve a homogeneous
mixture (essentially streak-free) shall not exceed the time stated by the manufacturer.
5.4.3 Consistency
When tested according to 7.2, the test disc diameter shall be in the range given in Table 1 for the
consistency assigned to the material by the manufacturer.
5.4.4 Working time
When tested according to 7.3, the working time shall not be less than that stated in the manufacturer’s
instructions.
5.4.5 Detail reproduction
When tested according to 7.4, the line width reproduced shall not exceed the appropriate value given in
Table 1.
5.4.6 Linear dimensional change
When tested according to 7.5, the linear dimensional change shall not exceed the appropriate value
given in Table 1.
5.4.7 Compatibility with gypsum
The impression material shall impart a smooth surface to and separate cleanly from the gypsum model
material poured against it. When tested according to 7.6, the line width reproduced shall not exceed the
appropriate value given in Table 1.
5.4.8 Elastic recovery
When tested according to 7.7, the elastic recovery shall be greater than or equal to the value given in
Table 1.
5.4.9 Strain in compression
When tested according to 7.8, the strain in compression shall be in the appropriate range given in
Table 1.
ISO 4823:2021(E)
5.4.10 Minimum time in the oral cavity for bite registration materials
When tested according to 7.9, the minimum time in the oral cavity shall be smaller than or equal to the
value given by the manufacturer in the instructions for use.
5.4.11 Compression set of bite registration materials
When tested according to 7.9, the compression set after load removal shall be less or equal to the value
given in Table 1.
5.4.12 Hardness of bite registration materials
When tested according to 7.10, the hardness of the material shall be greater than or equal to the value
given in Table 1.
Table 1 — Characteristic and physical property requirements
Test subclause no. and description
7.2 7.4 7.5 7.6 7.7 7.8 7.9 7.10
Consistency Detail re- Linear di- Compati- Elastic Strain in Compres- Hardness
production mension- bility with recovery compression sion set
(test disc Shore A
al change gypsum
diameter) (line width % % mm
Type
repro- % (line width
mm
a
duced) reproduced)
max.
a
µm
µm
min. max. min. min. | max. max. min.
0 — 35 75 1,5 75 96,5 0,8 | 20,0 - -
1 — 35 50 1,5 50 96,5 0,8 | 20,0 - -
2 31 41 20 1,5 50 96,5 2,0 | 20,0 - -
3 36 — 20 1,5 50 96,5 2,0 | 20.0 - -
B - - - 1,5 - - - | - 0,1 50
a
The line reproduction shall be considered satisfactory if the required line a, b, or c is continuous between the lines d
and d . See test block in Figure A.4.
6 Pre-test planning approaches
The information in this Clause is provided to help test operators avoid losses of time due to trial and
error efforts occurring when such information is not considered before test procedures, such as those
described in Clause 7, are begun.
6.1 Sampling
Observe the following guidelines when procuring samples of materials for testing.
a) Procure only samples that have been packaged for retail or franchise marketing and that have
labelling Use by dates that have not expired.
b) Wherever possible, select only those samples that have the same lot (batch) number [see 5.2.1 e)].
c) Sample size required
— as much as 900 ml might be needed for conducting all required tests and for the considerable
practice that might be necessary for the test operator to become proficient in specimen
preparation and testing, and
6 © ISO 2021 – All rights reserved
ISO 4823:2021(E)
— for the gypsum materials needed for the impression material compatibility with gypsum test,
at least 1 000 g.
6.2 Pre-test product examinations
These examinations are helpful in determining whether the sample procured (6.1) is fit for objective
testing.
6.2.1 Examinations for compliance with labelling requirements
Examine the consumer packaging components for compliance with the labelling requirements before
any attempt to open a packaging component has defaced or obliterated any labelling entry information
needed for storage or use of the product (for example, Use by date).
At this point, it is recommended that the following information about the product be recorded for future
reference in a test record format, if possible:
a) brand name, type, and class of the product, if applicable, along with an added numeric or alpha
numeric symbol for the sample;
b) Use by date for the product;
c) lot number for each component.
6.2.2 Examinations for effectiveness of the packaging
Before opening any primary packaging container, examine it for possibilities that the quality of
the content might have been compromised since its manufacture. For example, evidence such as the
following:
a) loose tube caps or canister lids or leakage;
b) container rupture or punctures;
c) shrinkage of the content of a container such as can be detected by sight, sound, or touch.
Caution — Do not use any compromised materials for preparing specimens.
6.2.3 Examinations for compliance with requirements for instructions for use
a) Before discarding any secondary packaging:
— examine the labels to determine whether they include any of the instructions for use information
specified in 5.3, and
— locate and retain any instruction sheet that might have been provided outside the primary
container.
b) Examine the instructions for use for compliance with requirements stated in 5.3.3.
6.3 Essential pre-test preparatory practices
6.3.1 Laboratory conditions
Unless otherwise specified in this document, conduct all specimen preparation and testing under the
ambient laboratory conditions of (23 ± 2) °C and (50 ± 10) % relative humidity. And, unless otherwise
specified, bring all equipment and materials to be used in the tests to the ambient temperature before
beginning specimen preparation.
ISO 4823:2021(E)
6.3.2 Apparatus function verification steps
a) Examine all accessories, instruments, and equipment for functional effectiveness before they are
used in a test.
b) Clear all instrumentation or equipment surfaces that will come in contact with the specimen
material of any contaminants that might influence the test result.
c) Perform whatever calibration steps necessary to ensure that the items comply with specifications
stated for them in this document or in ISO 6873:2013.
6.3.3 Volume of materials to be mixed for each specimen
Unless otherwise specified in this document, the volume mixed for each specimen shall be (15 ± 0,5) ml.
6.3.4 Standardized approaches to proportioning, mixing, and handling of hand mixed
materials to be tested
See Annex B.
6.3.5 Timing for the specimen preparation and test procedures
A timing device such as a stop watch accurate to 1 s over a 30 s period shall be used for timing each
requiring specimen preparation and test step.
6.3.6 Simulated oral time/temperature treatment of specimens formed in completely closed
mould assemblies
NOTE For the detail reproduction, linear dimensional change, elastic recovery, and strain in compression
test specimens.
Immediately after the specimen forming material has been completely enclosed in the specimen forming
assembly, the entire assembly shall be conditioned at (35 ± 1) °C for the time period recommended by
the manufacturer for leaving the material in the mouth.
6.4 Pass/fail determinations
The minimum number of specimens to be tested for pass/fail determinations shall be five. If at least
four of the five specimens comply with the related requirement, the material passes. If only one or two
specimens comply, the material fails. If only three specimens comply, make a series of five additional
specimens. If four of the second series of specimens comply, the material passes. Otherwise, the
material fails.
6.5 Expression of test
...
The EN ISO 4823:2021 standard presents comprehensive specifications for elastomeric impression and bite registration materials utilized in dentistry. Its scope is well-defined, addressing critical requirements and test methods essential for ensuring the quality and reliability of these materials in clinical applications. One of the primary strengths of this standard lies in its systematic approach to defining the properties of elastomeric materials, including their physical and mechanical characteristics, thereby ensuring that dental professionals can achieve accurate impressions and reliable bite registrations. This is particularly relevant for maintaining high standards of care in dental practices, where precision is paramount. Additionally, the inclusion of specific test methods for evaluating these materials enhances its utility, as it establishes a benchmark for quality assurance. This clarity in requirements not only aids manufacturers in product development but also assists dental practitioners in selecting appropriate materials, ensuring that patient outcomes are optimized. Although the standard does not cover potential biological hazards associated with elastomeric impression and bite registration materials, it clearly references other standards, such as ISO 7405 and the ISO 10993 series, which are designed to address these concerns. This emphasis on interdisciplinary standards ensures that users can access comprehensive guidance on safety alongside performance, a crucial consideration in contemporary dental practice. Overall, the EN ISO 4823:2021 standard is immensely relevant to the dentistry field, providing a robust framework for the evaluation and selection of elastomeric materials. Its thoroughness and focus on defined requirements make it a vital document for dental practitioners and manufacturers alike, fostering safety and efficacy in dental procedures.
EN ISO 4823:2021は、歯科におけるエラストマー印象および咬合登録材料に関する標準文書であり、エラストマー材の特性や試験方法を明確に規定しています。この標準の適用範囲は、印象および咬合登録に使用されるエラストマー材料に関連する要求事項を網羅しています。 この文書の強みは、エラストマー印象材料および咬合登録材料の品質と信頼性を確保するための具体的な要求と試験方法を提供している点です。これにより、歯科医療現場での材料選択や使用において、一定の基準を設けることが可能となり、患者の安全を確保する上でも重要な役割を果たします。 また、この標準は国際的な整合性を持っており、さまざまな国でのエラストマー印象材料の取り扱いや評価に対して共通の基準を提供します。これにより、国際貿易においてもエラストマー材料の品質に関する信頼を高め、製造者や消費者間の信頼関係の構築に寄与します。 ただし、EN ISO 4823:2021は、材料に関連する生物学的危険についての評価には触れていません。この点に関しては、ISO 7405およびISO 10993シリーズが参照されており、併用することでより包括的なリスク管理が可能になります。全体として、この標準はエラストマー印象および咬合登録材料の使用に関わる専門家にとって非常に有益なガイドラインとなっています。
Die Norm EN ISO 4823:2021 regelt die Anforderungen und Prüfmethoden für elastomerische Abform- und Bissregistrierungsmaterialien in der Zahnmedizin. Der Geltungsbereich dieser Norm ist besonders relevant, da sie sicherstellt, dass die verwendeten Materialien die erforderlichen Qualitätstests durchlaufen und im klinischen Einsatz zuverlässige Ergebnisse liefern. Eine der großen Stärken der EN ISO 4823:2021 liegt in ihrer umfassenden und detaillierten Spezifikation der Prüfmethoden, die eine konsistente und reproduzierbare Bewertung der elastomerischen Materialien ermöglichen. Dies ist entscheidend für Zahnärzte und Zahntechniker, da die Qualität der Abformungen und Bissregistrierungen direkt die Ergebnisse der zahnärztlichen Behandlungen beeinflusst. Durch die Festlegung klarer Kriterien wird das Vertrauen in die verwendeten Produkte gestärkt und die Patientensicherheit erhöht. Die Norm legt auch den Fokus auf die Eigenschaften der Abformmaterialien, wie Elastizität, Viskosität und Oberflächenbeschaffenheit, die für eine effektive Anwendung in der Zahnmedizin unerlässlich sind. Durch die Einhaltung dieser Standards können Zahnarztpraxen sicherstellen, dass sie hochwertige Materialien verwenden, die den Anforderungen der Branche entsprechen. Es ist jedoch wichtig zu beachten, dass die EN ISO 4823:2021 keine biologischen Gefahren behandelt, die möglicherweise mit den Materialien verbunden sind. Diese Thematik wird in der ISO 7405 und der ISO 10993-Serie angesprochen. Daher ist es ratsam für Anwender, sich auch mit diesen Normen auseinanderzusetzen, um ein umfassendes Verständnis der Sicherheit und Biokompatibilität der verwendeten Materialien zu erlangen. Insgesamt stellt die EN ISO 4823:2021 einen bedeutenden Standard in der Zahntechnik dar, der die Qualität und Sicherheit von elastomerischen Abform- und Bissregistrierungsmaterialien gewährleistet und damit wesentlich zur Weiterentwicklung der zahnmedizinischen Praxis beiträgt.
La norme EN ISO 4823:2021, intitulée "Dentisterie - Matériaux d'impression élastomères et matériaux d'enregistrement de morsure", est un document essentiel qui établit des exigences claires et des méthodes d'essai pour les matériaux utilisés dans les impressions dentaires. Sa portée couvre de manière exhaustive les propriétés nécessaires pour garantir la fiabilité et la performance des matériaux d'impression élastomères. L'un des points forts de cette norme est qu'elle fournit des critères précis relatifs à la qualité et à la durabilité des matériaux d'impression, permettant ainsi aux professionnels de la dentisterie d'assurer des résultats précis et cohérents dans leurs travaux. La standardisation des matériaux d'enregistrement de morsure a également une grande importance, car elle contribue à améliorer la communication entre les praticiens et les laboratoires dentaires, garantissant ainsi une intégration fluide au sein des processus cliniques. La norme souligne également l'importance des tests pour vérifier les caractéristiques des matériaux, en s'assurant qu'ils respectent les standards requis de résistance et de fiabilité. Cela renforce non seulement la sécurité des traitements dentaires, mais également la confiance des patients envers les procédures effectuées par leur dentiste. Cependant, il est important de noter que la norme EN ISO 4823:2021 ne traite pas des dangers biologiques associés aux matériaux, qui sont abordés séparément dans la norme ISO 7405 et la série ISO 10993. Cela souligne la nécessité d'une approche intégrale lors de l'évaluation de la sécurité des matériaux dentaires. En conclusion, EN ISO 4823:2021 fait figure de référence incontournable pour les professionnels de la dentisterie, en établissant des exigences fondamentales pour les matériaux d'impression élastomères et d'enregistrement de morsure. Sa pertinence dans le domaine dentaire est indiscutable, car elle harmonise les pratiques et encourage l'innovation tout en veillant à la sécurité du patient.
SIST EN ISO 4823:2021 표준은 치과 분야에서 사용되는 엘라스토머 인상 및 물어보기 등록 재료에 대한 요구 사항과 테스트 방법을 규명하고 있습니다. 이 표준의 범위는 적절한 재료의 선택과 품질 관리를 위한 기초를 제공하며, 치과 진료의 신뢰성을 높이는 데 기여합니다. 이 표준의 강점 중 하나는 실용적이고 구체적인 테스트 방법을 제시한다는 점입니다. 이를 통해 제조업체들은 제품이 요구되는 성능 기준을 충족하는지 검증할 수 있으며, 최종 사용자인 치과 의사 및 환자에게 안전하고 효과적인 재료를 보장할 수 있습니다. 표준이 명시하는 요구 사항은 엘라스토머 재료의 사용에 있어 신뢰성을 보장하며, 이는 정확한 인상 채취와 적절한 물어보기 등록을 가능하게 합니다. 또한, SIST EN ISO 4823:2021은 치과 재료의 품질 관리 체계 구축에 필요한 기초 정보를 제공합니다. 이는 제조업체가 규제를 준수하고, 제품의 일관성을 유지하며, 시장에서 경쟁력을 갖출 수 있도록 지원합니다. 특히, 이 표준은 ISO 7405 및 ISO 10993 시리즈와 연계하여 생물학적 위험을 평가하는 사항은 다루지 않지만, 재료의 성능과 안전성을 확보하는 데 중점을 두고 있습니다. 따라서 EN ISO 4823:2021 표준은 엘라스토머 인상 및 물어보기 등록 재료의 개발과 적용에 있어 필수적인 가이드라인으로, 치과 분야의 현대적 요구에 부합하는 중요한 문서입니다.
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