EN ISO 21563:2013
(Main)Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
ISO 21563:2013 specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.
Zahnheilkunde - Hydrokolloidabformmaterialien (ISO 21563:2013)
Diese Internationale Norm legt Anforderungen und Prüfverfahren fest, mit denen ermittelt werden kann, ob die in der Zahnheilkunde verwendeten elastischen Agar- und Alginat-Hydrokolloidabformmaterialien auf Wasserbasis, so wie sie im Einzelhandel verkauft werden, über die Qualität verfügen, die für ihre Anwendung benötigt wird. Sie enthält auch Anforderungen an die Kennzeichnung und an die Gebrauchsanweisung.
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 7405 und ISO 10993 heranzuziehen.
Médecine bucco-dentaire - Produits pour empreintes à base d'hydrocolloïdes (ISO 21563:2013)
L'ISO 21563:2013 spécifie les exigences et essais permettant de déterminer si les produits pour empreintes dentaires à base d'hydrocolloïde d'alginate et d'agar-agar aqueux et élastiques, tels qu'ils sont préparés pour la commercialisation au détail, présentent la qualité requise aux fins recherchées. Elle spécifie également les exigences relatives à l'étiquetage et la notice d'utilisation.
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)
Ta mednarodni standard določa zahteve in preskuse za ugotavljanje, ali hidrokoloidni materiali za dentalno oblikovanje (elastični vodni agar in alginat), kot so pripravljeni za trženje v prodaji na drobno, izpolnjujejo zahteve glede kakovosti, potrebne za njihovo predvideno uporabo. Prav tako določa zahteve za označevanje in navodila za uporabo.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2013
1DGRPHãþD
SIST EN 21563:2000
SIST EN ISO 13716:2001
SIST EN ISO 1564:2000
Zobozdravstvo - Hidrokoloidni materiali za oblikovanje (odtise) (ISO 21563:2013)
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Zahnheilkunde - Hydrokolloidabformmassen (ISO 21563:2013)
Médecine bucco-dentaire - Matériaux d'impression hydrocolloïde (ISO 21563:2013)
Ta slovenski standard je istoveten z: EN ISO 21563:2013
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 21563
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2013
ICS 11.060.10 Supersedes EN 21563:1991, EN ISO 13716:2000, EN
ISO 1564:1998
English Version
Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
Médecine bucco-dentaire - Produits pour empreintes à Zahnheilkunde - Hydrokolloidabformmassen (ISO
base d'hydrocolloïdes (ISO 21563:2013) 21563:2013)
This European Standard was approved by CEN on 22 June 2013.
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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21563:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 21563:2013) 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 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014.
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 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998.
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 21563:2013 has been approved by CEN as EN ISO 21563:2013 without any modification.
INTERNATIONAL ISO
STANDARD 21563
First edition
2013-08-15
Dentistry — Hydrocolloid impression
materials
Médecine bucco-dentaire — Produits pour empreintes à base
d’hydrocolloïdes
Reference number
ISO 21563:2013(E)
©
ISO 2013
ISO 21563:2013(E)
© ISO 2013
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2013 – All rights reserved
ISO 21563:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification of agar hydrocolloid impression materials . 3
5 Requirements — Characteristics and properties . 4
6 Pre-test planning approaches . 5
6.1 Sampling . 5
6.2 Pre-test product examinations . 5
6.3 Essential pre-test preparatory practices . 6
7 Test methods . 8
7.1 Working time test (alginate materials only) . 8
7.2 Initial setting time test (alginate impression materials only) . 9
7.3 Detail reproduction test before and after specimen disinfection . 9
7.4 Compatibility with gypsum test .12
7.5 Elastic recovery test.13
7.6 Strain-in-compression test .16
7.7 Tear strength test .17
7.8 Linear dimensional change test (Type 3A agar materials with companion alginate only) 19
7.9 Tensile bond strength test (Type 3A agar/companion alginate material specimen only) .21
8 Requirements — Labelling and instructions for use .23
8.1 Labelling .23
8.2 Requirements — Instructions for use .24
Annex A (normative) Figures illustrating instruments and accessories used in tests .27
Annex B (informative) Tear test specimen preparation steps for an optional gripping method .41
Bibliography .45
ISO 21563:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 21563 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This first edition of ISO 21563 constitutes a consolidation of the three standards listed below and, as
such, cancels and replaces, in whole, all three of the standards listed.
— ISO 1563:1990, Dentistry — Alginate impression materials
— ISO 1564:1995, Dental aqueous impression materials based on agar
— ISO 13716:1999, Dentistry — Reversible/irreversible hydrocolloid impression materials systems
Re-evaluations of all the provisions stated in the three ISO standards to be included in the consolidation
led to the significant technical changes listed as follows.
— The alginate hydrocolloid impression materials (ISO 1563) are now required to be subject to the
same tear strength test that has been in effect for the agar hydrocolloid impression materials
(ISO 1564 and ISO 13716) instead of being subject to a compressive strength test.
— The requirement for the alginate impression material powder materials to be “free from foreign
materials”, as stated in ISO 1563, has not been carried forward into the consolidation because no
objective test has been specified for determining compliance with the requirement.
— The “gelation temperature” requirements in ISO 1564 and ISO 13716 have not been carried forward
for the agar impression materials because results of the elastic recovery test (7.5), if conducted
following the required manufacturer’s instructions for use (8.2.1 and/or 8.2.2), will indicate
whether adequate gelation will take place during clinical use of the materials.
iv © ISO 2013 – All rights reserved
ISO 21563:2013(E)
Introduction
Parties seeking clarification of any provisions of this International Standard, or desiring to recommend
improvements for the next edition, are encouraged to do so by contacting ISO/TC 106, Dentistry, whose
address can be obtained through inquiry to the national standards body representing the interests of
the inquiring parties.
INTERNATIONAL STANDARD ISO 21563:2013(E)
Dentistry — Hydrocolloid impression materials
1 Scope
This International Standard specifies the requirements and tests for helping determine whether the
elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail
marketing, are of the quality needed for their intended purposes. It also specifies requirements for
labelling and instructions for use.
NOTE This International Standard specifies no requirements or tests for freedom from unacceptable
biological hazards. However, it is recommended that, to address possible biological hazards associated with the
use of hydrocolloid impression materials, interested p
...
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