EN ISO 11143:2008
(Main)Dentistry - Amalgam separators (ISO 11143:2008)
Dentistry - Amalgam separators (ISO 11143:2008)
ISO 11143:2008 specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, instructions for use, operation and maintenance.
All tests described in ISO 11143:2008 are type tests.
Zahnheilkunde - Amalgamabscheider (ISO 11143:2008)
Diese Internationalen Norm legt Anforderungen an und Prüfverfahren für Amalgamabscheider fest, die in Verbindung mit der zahnärztlichen Ausrüstung am zahnärztlichen Behandlungsplatz eingesetzt werden. Diese Norm spezifiziert den Wirkungsgrad eines Amalgamabscheiders über die Menge des zurückgehaltenen Amalgams, das in einem Laborprüfverfahren ermittelt wird. Außerdem werden Anforderungen an eine sichere Funktionsweise des Amalgamabscheiders, an die Kennzeichnung und an die Gebrauchsanweisung sowie an die Anweisungen für den Betrieb und die Wartung festgelegt.
Alle in dieser Internationalen Norm beschriebenen Prüfungen sind Typprüfungen.
Art dentaire - Séparateurs d'amalgame (ISO 11143:2008)
L'ISO 11143:2008 spécifie les exigences et les méthodes d'essai relatives aux séparateurs d'amalgame utilisés en association avec le matériel dentaire du centre de traitement dentaire. Elle spécifie le rendement des séparateurs en termes de niveau de rétention d'amalgame, basé sur un essai en laboratoire, ainsi que le mode opératoire d'essai permettant de calculer ce rendement. Elle comporte également des exigences relatives à la sécurité de fonctionnement du séparateur d'amalgame, au marquage et aux instructions d'utilisation, de fonctionnement et de maintenance.
Tous les essais décrits dans l'ISO 11143:2008 sont des essais de type.
Zobozdravstvena oprema - Amalgamski ločevalniki (ISO 11143:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN ISO 11143:2000
SIST EN ISO 11143:2000/AC:2002
=RER]GUDYVWYHQDRSUHPD$PDOJDPVNLORþHYDOQLNL ,62
Dental equipment - Amalgam separators (ISO 11143:2008)
Zahnärztliche Ausrüstung - Amalgamabscheider (ISO 11143:2008)
Matériel dentaire - Séparateurs d'amalgame (ISO 11143:2008)
Ta slovenski standard je istoveten z: EN ISO 11143:2008
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11143
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.060.20 Supersedes EN ISO 11143:1999
English Version
Dentistry - Amalgam separators (ISO 11143:2008)
Art dentaire - Séparateurs d'amalgame (ISO 11143:2008) Zahnheilkunde - Amalgamabscheider (ISO 11143:2008)
This European Standard was approved by CEN on 21 June 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11143:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
This document (EN ISO 11143:2008) 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 January 2009, and conflicting national standards shall be withdrawn at
the latest by January 2009.
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 11143:1999.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11143:2008 has been approved by CEN as a EN ISO 11143:2008 without any modification.
INTERNATIONAL ISO
STANDARD 11143
Second edition
2008-07-01
Dentistry — Amalgam separators
Art dentaire — Séparateurs d'amalgame
Reference number
ISO 11143:2008(E)
©
ISO 2008
ISO 11143:2008(E)
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ii © ISO 2008 – All rights reserved
ISO 11143:2008(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Classification. 2
5 Requirements. 3
5.1 Efficiency. 3
5.2 Warning system for collecting container . 3
5.3 Alarm system for collecting container . 3
5.4 Alarm system for malfunction of amalgam separator . 3
5.5 Removal of removable filled collecting container. 3
5.6 Maximum fillable volume of the removable collecting container . 4
5.7 Electrical safety. 4
6 Sampling. 4
7 Test apparatus. 4
7.1 Set-up of test apparatus. 4
7.2 Installation of amalgam separator . 5
8 Test sample. 7
8.1 Preparation of test sample. 7
8.2 Particle fraction sizes. 7
8.3 Mass of dry test sample . 7
8.4 Particle fraction size distribution. 7
8.5 Preparation of test slurry . 9
8.5.1 Reagents. 9
8.5.2 Apparatus. 9
8.5.3 Procedure. 9
9 Test method. 10
9.1 General. 10
9.2 Preconditioning. 10
9.3 Efficiency test. 10
9.4 Number of tests. 13
9.5 Calculation of efficiency . 13
9.6 Determination of efficiency. 14
9.7 Test of warning system for removable collecting container. 14
9.8 Test of alarm system for removable collecting container. 14
9.9 Test of alarm system for malfunction of amalgam separator . 14
9.10 Removal of filled collecting container. 14
9.11 Maximum fillable volume of the removable collecting container . 14
9.12 Electrical safety. 14
10 Test report. 15
11 Manufacturer's instructions for installation, use, maintenance and service . 16
12 Marking. 16
12.1 General. 16
12.2 Marking of amalgam separator. 17
12.3 Marking of liquid inlet and outlet of the amalgam separator . 17
ISO 11143:2008(E)
12.4 Marking of removable collecting container. 17
Annex A (informative) Preparation of amalgam test sample . 18
Annex B (informative) Procedure for grinding the hardened amalgam. 21
Annex C (informative) Examination of particle fraction 3 using sedimentation with X-ray
absorption. 22
Annex D (informative) Particle fraction size distribution of amalgam in dental waste water. 24
Bibliography . 25
iv © ISO 2008 – All rights reserved
ISO 11143:2008(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, P
...
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