SIST EN ISO 4823:2015
(Main)Dentistry - Elastomeric impression materials (ISO 4823:2015)
Dentistry - Elastomeric impression materials (ISO 4823:2015)
This International Standard specifies the requirements and tests that the state-of-the art body of
knowledge suggests for helping determine whether the elastomeric impression materials, as prepared
for retail marketing, are of the quality needed for their intended purposes.
NOTE This International Standard does not address possible biological hazards associated with the
materials. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of
such hazards.
Zahnheilkunde - Elastomere Abformmaterialien (ISO 4823:2015)
Diese Internationale Norm legt Anforderungen und Prüfverfahren mit dem Ziel fest, dass die neuesten Kenntnisse bei der Bestimmung helfen, ob die für den marktgerechten Verkauf hergestellten elastomeren Abformmaterialien die für den Verwendungszweck geforderte Qualität aufweisen.
ANMERKUNG In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 10993-1 und ISO 7405 heranzuziehen.
Médecine bucco-dentaire - Produits pour empreintes, à base d'élastomères (ISO 4823:2015)
L'ISO 4823:2015 spécifie les exigences et les essais suggérés par l'état actuel des connaissances pour aider à déterminer si les matériaux à empreintes à base d'élastomères commercialisés ont la qualité requise pour l'usage prévu.
Zobozdravstvo - Elastomerni materiali za odtise (ISO 4823:2015)
Ta mednarodni standard določa zahteve in preskuse, ki so v najsodobnejših zbirkah znanja predlagani za ugotavljanje, ali elastomerni materiali za odtise, kot so pripravljeni za trženje v prodaji na drobno, izpolnjujejo zahteve glede kakovosti, potrebne za njihovo predvideno uporabo.
OPOMBA: Ta mednarodni standard ne obravnava morebitnih bioloških nevarnosti, povezanih z
materiali. Zato se zainteresiranim stranem priporoča uporaba standardov ISO 7405 in ISO 10993 za oceno takih tveganj.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 4823:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 4823:2001
SIST EN ISO 4823:2001/A1:2008
SIST EN ISO 4823:2001/AC:2006
Zobozdravstvo - Elastomerni materiali za odtise (ISO 4823:2015)
Dentistry - Elastomeric impression materials (ISO 4823:2015)
Zahnheilkunde - Elastomere Abformmaterialien (ISO 4823:2015)
Médecine bucco-dentaire - Produits pour empreintes, à base d'élastomères (ISO
4823:2015)
Ta slovenski standard je istoveten z: EN ISO 4823:2015
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 4823:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 4823:2015
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SIST EN ISO 4823:2015
EUROPEAN STANDARD
EN ISO 4823
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.060.10 Supersedes EN ISO 4823:2000
English Version
Dentistry - Elastomeric impression materials (ISO 4823:2015)
Médecine bucco-dentaire - Matériaux à empreintes, à base Zahnheilkunde - Elastomere Abformmaterialien (ISO
d'élastomères (ISO 4823:2015) 4823:2015)
This European Standard was approved by CEN on 20 June 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4823:2015 E
worldwide for CEN national Members.
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SIST EN ISO 4823:2015
EN ISO 4823:2015 (E)
Contents Page
European foreword .3
2
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SIST EN ISO 4823:2015
EN ISO 4823:2015 (E)
European foreword
This document (EN ISO 4823:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in
collaboration with Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4823:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 4823:2015 has been approved by CEN as EN ISO 4823:2015 without any modification.
3
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SIST EN ISO 4823:2015
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SIST EN ISO 4823:2015
INTERNATIONAL ISO
STANDARD 4823
Fourth edition
2015-08-01
Dentistry — Elastomeric impression
materials
Médecine bucco-dentaire — Matériaux à empreintes, à base
d’élastomères
Reference number
ISO 4823:2015(E)
©
ISO 2015
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements for packaging, labelling, and information in manufacturer’s instructions .2
5.1 Packaging requirements . 2
5.2 Labelling requirements . 3
5.2.1 Outer packages (containing one or more primary containers) . . 3
5.2.2 Primary containers within outer packaging . 3
5.3 Requirements for information in manufacturer’s instructions . 3
5.3.1 General. 3
5.3.2 Identifying information . . 3
5.3.3 Specific instructions for use . 4
5.4 Requirements for characteristics and properties . 4
5.4.1 Component colours . 4
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 4
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
6 Pre-test planning approaches . 6
6.1 Sampling . 6
6.2 Pre-test product examinations . 6
6.2.1 Examinations for compliance with labelling requirements . 6
6.2.2 Examinations for effectiveness of the packaging . 6
6.2.3 Examinations for compliance with requirements for instructions for use . 6
6.3 Essential pre-test preparatory practices . 7
6.3.1 Laboratory conditions . 7
6.3.2 Apparatus function verification steps . 7
6.3.3 Volume of materials to be mixed for each specimen . 7
6.3.4 Order for conducting examinations and tests . 7
6.3.5 Standardized approaches to proportioning, mixing, and handling of hand
mixed materials to be tested. 7
6.3.6 Timing for the specimen preparation and test procedures . 7
6.3.7 Simulated oral time/temperature treatment of specimens formed in
completely closed mould assemblies . 7
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) . 8
7.1.3 Pass/fail determination and expression of results. 8
7.2 Consistency . 8
7.2.1 Apparatus and materials . 8
7.2.2 Advance preparation steps. 9
7.2.3 Specimen preparation and test procedure (3 specimens) . 9
7.2.4 Pass/fail determination and expression of results.10
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
7.3 Working-time .10
7.3.1 Apparatus and materials applicable to the Type 0 materials .10
7.3.2 Working time test for the Type 0 materials .10
7.3.3 Apparatus and materials applicable to the Types 1, 2, and 3 .12
7.3.4 Pretest apparatus function verification and assembly .12
7.3.5 Pass/fail determination and expression of results.13
7.4 Detail reproduction .13
7.4.1 Apparatus and materials .13
7.4.2 Specimen preparation (three specimens) .14
7.4.3 Test procedure .14
7.4.4 Pass/fail determination and expression of results.14
7.5 Linear dimensional change .15
7.5.1 Apparatus and materials .15
7.5.2 Test block line-length measurement procedure .15
7.5.3 Specimen preparation (three specimens) .15
7.5.4 Test specimen measurement .16
7.6 Compatibility with gypsum .16
7.6.1 Apparatus and materials .16
7.6.2 Specimen preparation .17
7.6.3 Test procedure .18
7.6.4 Pass/fail determination and expression of results.18
7.7 Elastic recovery .18
7.7.1 Apparatus and materials .18
7.7.2 Specimen preparation .18
7.7.3 Test procedure .19
7.7.4 Calculation of results .19
7.7.5 Pass/fail determination and expression of results.19
7.8 Strain-in-compression .20
7.8.1 Apparatus .20
7.8.2 Specimen preparation .20
7.8.3 Test procedure .20
7.8.4 Calculation of results .20
7.8.5 Pass/fail determination and expression of results.20
Annex A (normative) Figures cited in this International Standard .21
Annex B (normative) Standardized hand mixing methods .35
Annex C (informative) Working-time test apparatus components − Possible sources .38
Bibliography .39
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This fourth edition cancels and replaces the third edition (ISO 4823:2000), which has been technically
revised with the following changes:
— modification of the sequence of requirements having the requirements for packaging and labelling
listed before the requirements for characteristics and properties;
— the restriction that the working time shall be at least 30 s longer than the mixing time was eliminated;
this was considered necessary in view of the fact that several products have shorter working time;
— working time test procedure using the dead weight method (Sink-in method) for Type 0 materials
which had been exempt from this requirement in the third edition was introduced (see 7.3.2);
— the current displacement Rheometer procedure stated in ISO 4823:2000 will continue to be used
for testing Type 1, 2, and 3 materials without modifications;
— concerning the order in which some clauses are presented, whereas in later years, most dental
product standards have been structured to have the requirements and test methods clauses appear
before the requirements for labelling and instructions for use clauses, this International Standard
gives first ordering to the labelling and instructions for use requirements. This change was thought
to be necessary because experience informs us that test operators will be better equipped to obtain
success in testing if they first take into account the information available in the labelling and in the
instructions for use;
— Clause 6 has been added for reasons explained in its first paragraph;
— concerning the Annexes
— Annex A was created due to the ISO Central Secretariat suggestion that all figures, grouped
together instead of being presented individually on related pages of the text, are to be presented
in a normative Annex and numbered according to existing rules. This is to make it easier for the
figures to be located by users of the document;
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
— Annex B provides for standardized hand mixing methods to be used by test operators so that
specimen preparation mixing of the test specimens will be uniform and consistently fairer to
the various products;
— Annex C identifies sources for the working-time test apparatus and the linear variable
displacement transducer (LVTD).
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SIST EN ISO 4823:2015
INTERNATIONAL STANDARD ISO 4823:2015(E)
Dentistry — Elastomeric impression materials
1 Scope
This International Standard specifies the requirements and tests that the state-of-the art body of
knowledge suggests for helping determine whether the elastomeric impression materials, as prepared
for retail marketing, are of the quality needed for their intended purposes.
NOTE This International Standard does not address possible biological hazards associated with the
materials. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of
such hazards.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 6873, Dentistry — Gypsum products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
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, as required to achieve the purpose for which it is intended
3.2
elastic recovery test
DEPRECATED: compression set
DEPRECATED: permanent deformation
DEPRECATED: recovery from deformation
〈elastic impression materials〉 method of determining whether the materials possess the elastic
properties required to recover adequately after deformation occurring when the materials used for
forming impressions are removed from the mouth
3.3
extrusion mixing
method by which two or more material components are extruded simultaneously from their separate
primary containers through a special mixing tip 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
3.5
primary packaging
container designed to come into direct contact with the product
[SOURCE: ISO 21067:2007, 2.2.2, modified — “packaging” replaced by “container” in the definition.]
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
3.6
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.
3.7
outer package
wrapping or carton, which may be required by law or a standard to bear specified labelling, used to
cover one or more primary containers in preparation for retail marketing
3.8
strain-in-compression test
〈elastic impression materials〉 method of measuring the flexibility/stiffness property ranges of materials
so as to determine whether the set materials, when formed as impressions, can be removed from the
mouth without injury to impressed oral tissues and will have adequate stiffness in the more flexible
portions of impressions to resist deformation when model-forming products are poured against them
3.9
working time
period of time beginning with the commencement of mixing and ending before the material being
mixed has begun to exhibit elastic properties that will prevent the material from being manipulated
as required to form an impression or a mould having the desired surface detail and dimensional
characteristics
4 Classification
Materials covered by this International Standard are classified according to the following consistencies
determined immediately after completion of mixing according to the manufacturer’s instructions (see
5.3):
— Type 0: putty consistency;
— Type 1: heavy-bodied consistency;
— Type 2: medium-bodied consistency;
— Type 3: light-bodied consistency.
5 Requirements for packaging, labelling, and information in manufacturer’s
instructions
5.1 Packaging requirements
No packaging requirements are specified in this International Standard, but it is important for
manufacturers to take into account that the packaging should be such that it will not contaminate
or permit contamination of ingredients of the material components during recommended storage
conditions. Structure of the primary packaging should also be such that no leakage or inadvertent
extrusion of the contents can occur during storage and such that the containers will not rupture during
use of the extrusion methods recommended by the manufacturer.
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SIST EN ISO 4823:2015
ISO 4823:2015(E)
5.2 Labelling require
...
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