EN ISO 13897:2018
(Main)Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.
NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.
Zahnheilkunde - Wiederverwendbare Mischkapseln für zahnärztliches Amalgam (ISO 13897:2018)
Médecine bucco-dentaire - Capsules de mélange réutilisables pour amalgame dentaire (ISO 13897:2018)
ISO 13897:2018 spécifie les exigences applicables aux capsules de mélange réutilisables conçues pour contenir de la poudre d'alliage pour amalgame dentaire et du mercure à usage dentaire lorsqu'ils sont mélangés pour produire un amalgame dentaire. Il décrit également les méthodes d'essai utilisées pour déterminer la conformité à ces exigences.
NOTE L'ISO 7488 spécifie les exigences relatives aux mélangeurs. Bien que la capsule de mélange soit une partie essentielle du mélangeur, les exigences relatives à la capsule de mélange ne sont pas abordées dans l'ISO 7488.
Zobozdravstvo - Kapsule za ponovno uporabo zobnega amalgama (ISO 13897:2018)
Ta dokument določa zahteve za mešalne kapsule za večkratno uporabo, ki so predvidene za prašek zobnega amalgama in živo srebro za uporabo v zobozdravstvu, ko sta zmešana zaradi ustvarjanja zobnega amalgama, in
preskusne metode za določanje skladnosti s temi zahtevami.
OPOMBA ISO 7488 določa zahteve za mešalne stroje. Zahteve za mešalne kapsule niso obravnavane v standardu ISO 7488, čeprav je mešalna kapsula bistveni del mešalnega stroja.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2018
1DGRPHãþD
SIST EN ISO 13897:2004
Zobozdravstvo - Kapsule za ponovno uporabo zobnega amalgama (ISO
13897:2018)
Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)
Zahnheilkunde - Wiederverwendbare Mischkapseln für zahnärztliches Amalgam (ISO
13897:2018)
Art dentaire - Capsules réutilisables pour mélanger amalgame (ISO 13897:2018)
Ta slovenski standard je istoveten z: EN ISO 13897:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 13897
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 13897:2004
English Version
Dentistry - Dental amalgam reusable mixing-capsules (ISO
13897:2018)
Médecine bucco-dentaire - Capsules de mélange Zahnheilkunde - Wiederverwendbare Mischkapseln für
réutilisables pour amalgame dentaire (ISO zahnärztliches Amalgam (ISO 13897:2018)
13897:2018)
This European Standard was approved by CEN on 2 February 2018.
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, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13897:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 13897:2018) 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 August 2018, and conflicting national standards shall
be withdrawn at the latest by August 2018.
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 13897:2004.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13897:2018 has been approved by CEN as EN ISO 13897:2018 without any modification.
INTERNATIONAL ISO
STANDARD 13897
Second edition
2018-02
Dentistry — Dental amalgam reusable
mixing-capsules
Médecine bucco-dentaire — Capsules de mélange réutilisables pour
amalgame dentaire
Reference number
ISO 13897:2018(E)
©
ISO 2018
ISO 13897:2018(E)
© ISO 2018
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
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ii © ISO 2018 – All rights reserved
ISO 13897:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 Dimensions . 1
4.1.1 Length tolerance . 1
4.1.2 Diameter tolerance . 2
4.2 Loss of mass from the mixing-capsule during mixing. 2
4.3 Retention of dental amalgam in the mixing-capsule . 2
5 Sampling . 2
6 Measurements and test methods . 2
6.1 Dimensions . 2
6.1.1 Apparatus . 2
6.1.2 Test sample . 2
6.1.3 Procedure . 2
6.1.4 Report . 3
6.2 Loss of mass from the mixing-capsule during mixing. 3
6.2.1 Principle . 3
6.2.2 Test sample . 3
6.2.3 Apparatus . 3
6.2.4 Test procedure . 4
6.2.5 Expression of the results . 5
6.2.6 Report . 5
6.3 Retention of dental amalgam in the mixing-capsule . 5
6.3.1 Principle . 5
6.3.2 Test sample . 6
6.3.3 Apparatus . 6
6.3.4 Test procedure . 6
6.3.5 Expression of the results . 7
6.3.6 Additional testing . 8
6.3.7 Report . 8
7 Labelling . 8
Bibliography . 9
ISO 13897:2018(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
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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).
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URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 13897:2003) including Technical
Corrigendum 1 (ISO 13897:2003/Cor.
...
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