EN ISO 4823:2015
(Main)Dentistry - Elastomeric impression materials (ISO 4823:2015)
Dentistry - Elastomeric impression materials (ISO 4823:2015)
ISO 4823:2015 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 - Matériaux à 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword .3
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.
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
ISO 4823:2015(E)
© 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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
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 .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.