SIST EN ISO 11143:2008
Dental equipment - Amalgam separators (ISO 11143:2008)
Dental equipment - Amalgam separators (ISO 11143:2008)
This International Standard specifies requirements 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.
Zahnärztliche Ausrüstung - 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.
Matériel 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
SIST EN ISO 11143:2008
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
SIST EN ISO 11143:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11143:2008
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SIST EN ISO 11143:2008
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.
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SIST EN ISO 11143:2008
EN ISO 11143:2008 (E)
Contents Page
Foreword.3
2
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SIST EN ISO 11143:2008
EN ISO 11143:2008 (E)
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.
3
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SIST EN ISO 11143:2008
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SIST EN ISO 11143:2008
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
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
PDF disclaimer
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ii © ISO 2008 – All rights reserved
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SIST EN ISO 11143:2008
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
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SIST EN ISO 11143:2008
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
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SIST EN ISO 11143:2008
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, 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 11143 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 11143:1999) which has been technically
revised by means of the following changes:
a) the description of the test method has been improved;
b) testing at a minimum flow rate for certain types of separator is now required;
c) updated labelling requirement has been introduced.
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
Introduction
Amalgam separators are items of dental equipment designed to retain amalgam particles carried by the waste
water from the dental treatment centre, so as to reduce the number of amalgam particles and therefore the
mass of amalgam entering the sewage system.
Separation of the amalgam particles may be effected by the use of a centrifuge, sedimentation, filtration, or a
combination of any of these methods.
It is recognised that the test sample used to assess the efficiency of an amalgam separator should have a
particle size distribution which reflects the actual situation in dental treatment centres. The test sample used in
this International Standard is based on investigations that have been carried out to determine the particle size
distribution of amalgam particles in waste water from dental treatment centres (see Annex D).
The principle of the test is that the effluent water from the amalgam separator is collected in a vessel. The
collected effluent water, containing amalgam particles not retained by the amalgam separator, is filtered
through a series of preweighed filters. The filters, with the amalgam particles collected on them, are dried to a
constant weight in a desiccator at room temperature and the total mass of collected particles is measured to
determine the collection efficiency.
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SIST EN ISO 11143:2008
INTERNATIONAL STANDARD ISO 11143:2008(E)
Dentistry — Amalgam separators
1 Scope
This International Standard 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, and for instructions for use, operation and maintenance.
All tests described in this International Standard are type tests.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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 3585, Borosilicate glass 3.3 — Properties
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 9687, Dental equipment — Graphical symbols
ISO 24234:2004, Dentistry — Mercury and alloys for dental amalgam
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 24234 and the
following apply.
3.1
amalgam separator
item of dental equipment designed to remove amalgam particles from the waste water from the dental
treatment centre, so as to reduce the number of amalgam particles and therefore the mass (amount) of
amalgam entering the sewage system
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
3.2
collecting container
integrated part of the amalgam separator for retention of separated amalgam waste for the purpose of
recovery
3.3
dental treatment centre
combination of units consisting, as a minimum, of the dental unit and the dental chair combination, which
enable the dentist to perform patient therapy
3.4
efficiency of amalgam separator
mass percentage of the specified test sample retained by the amalgam separator
3.5
maximum fillable volume
level or volume defined by the maximum waste solids/sludge collecting capacity of the removable collecting
container of the amalgam separator at which the efficiency is unaffected
NOTE For the purposes of conducting these tests the maximum fillable volume is 95 % of the maximum solids/sludge
collecting capacity of the removable collecting container.
3.6
volume of an amalgam separator system
capacity of the collecting container and those cavities that are integral to the collecting container and/or to the
operation of the collecting container, including, but is not limited to, air-water separator tanks or cavities that
support or incorporate an outlet port for treated effluent, a flow restrictor, or water venturi
3.7
warning level
level, below the maximum fillable volume, at which the collecting container should be emptied or replaced
3.8
warning signal
auditory or visual sign, signal and/or other kind of indicator, or a combination thereof, indicating an adverse
condition likely to cause reduction of efficiency if unattended
3.9
alarm signal
auditory or visual sign, signal and/or other kind of indicator, or a combination thereof, indicating an adverse
condition affecting the efficiency of the amalgam separator
4 Classification
For the purposes of this International Standard, amalgam separator systems are classified according to the
method of separation into the following types:
⎯ Type 1: centrifugal system
⎯ Type 2: sedimentation system
⎯ Type 3: filter system
⎯ Type 4: any combination of Types 1, 2 and 3.
This classification is applicable to all amalgam separators, irrespective of whether the amalgam separator is
included in every dental treatment centre or built as a central amalgam separator for one or several dental
treatment centres.
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
5 Requirements
5.1 Efficiency
The efficiency of the amalgam separator shall be at least 95 % (mass fraction).
The determination of the efficiency shall be carried out under empty and full conditions for all types of
amalgam separators.
Test in accordance with 9.1 to 9.6.
5.2 Warning system for collecting container
The amalgam separator shall include a warning system to indicate the degree of filling at which the collecting
container should be emptied or replaced. The warning signal shall be activated at the warning level and before
the maximum fillable volume is reached.
Test in accordance with 9.7.
For Type 2 amalgam separators, the requirement for the warning system can be met if the manufacturer
clearly defines procedures by which the proper function of the amalgam separator is ensured, giving
controllable maintenance and recovery procedures as in 11.2.
Compliance shall be tested by visual inspection.
5.3 Alarm system for collecting container
The amalgam separator shall include an alarm system to indicate that the collecting container has reached the
maximum filling level, as specified by the manufacturer, at which the amalgam separator can perform to the
specified efficiency. The alarm signal shall be activated at the maximum fillable volume. The alarm signal shall
remain activated until the collecting container and/or filter has been emptied or replaced.
Test in accordance with 9.8.
For Type 2 amalgam separators, the requirement for the alarm system can be met if the manufacturer clearly
defines procedures by which the proper function of the amalgam separator is ensured, giving controllable
maintenance and recovery procedures as in 11.2.
Compliance shall be tested by visual inspection.
5.4 Alarm system for malfunction of amalgam separator
Malfunction of amalgam separators of Types 1 and 4, but only if Type 4 includes centrifugal systems, shall be
indicated by activation of an alarm system. It shall not be possible to inactivate signals during use until the
malfunction is corrected.
Test in accordance with 9.9.
5.5 Removal of removable filled collecting container
The removable filled collecting container shall be capable of being removed easily and safely without
discharging any of the contents into the public sewage system.
NOTE Filters are considered as removable collecting containers.
The removable filled collecting container shall be able to be sealed so that no leakage or spillage can occur
during handling and transportation.
Test in accordance with 9.10.
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
5.6 Maximum fillable volume of the removable collecting container
The maximum fillable volume of the removable collecting container that shall be handled during emptying shall
not exceed 4 l.
Test in accordance with 9.11.
5.7 Electrical safety
If an amalgam separator is electrically powered and
a) is connected as an integral part of the dental unit, it shall conform to IEC 60601-1;
b) is physically remote from the dental unit
1) but electrically connected, it shall conform to IEC 60601-1;
2) but not electrically connected, it shall conform to IEC 61010-1.
Test in accordance with 9.12.
6 Sampling
All type tests shall be made starting with the testing of one representative sample of the amalgam separator
(unused and empty).
7 Test apparatus
7.1 Set-up of test apparatus
The test apparatus, shown in Figure 1, consists of the following components:
7.1.1 Incoming water, passing through a water cartridge filter (7.1.2) and thereafter described as filtered
tap water.
7.1.2 Water cartridge filter, of polypropylene, with a nominal filter pore size of 1 µm.
7.1.3 Flow rate meter, for laboratory use, appropriate for measuring the maximum water flow rate stated by
the manufacturer of the amalgam separator and with a tolerance of ± 5 % of the full-scale reading.
7.1.4 Sample delivery hopper, of glass or stainless steel with an interior polished surface, with an outlet at
its lowest point having a diameter of the same size as the inlet diameter of the amalgam separator.
7.1.5 Amalgam separator, under test.
7.1.6 Two transparent hoses, of plastic with a minimum wall thickness of 5 mm and an interior smooth
surface for respectively connecting:
a) the outlet of the sample delivery hopper to the inlet of the amalgam separator, with the same inside
diameter as the outside diameter of the outlet of the delivery hopper;
b) the outlet of the amalgam separator to the effluent collecting vessel, with the same inside diameter as the
outside diameter of the outlet of the amalgam separator.
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
7.1.7 Effluent collecting vessel, of stainless steel with a polished interior surface, proved for a minimum
5
pressure of 2 ¥ 10 Pa (2 bar), with the following characteristics:
a) minimum volume of 45 l;
NOTE The volume of the effluent collecting vessel depends on the volume of water allowed by the maximum water
flow rate (see 9.3.2).
b) inlet for filtered tap water with an on/off valve;
c) inlet for compressed air with an on/off valve;
5
d) pressure gauge, capable of measuring in the pressure range of 0 Pa to 2 × 10 Pa with an accuracy of
0,6 % of full-scale pressure;
e) safety device to reduce overpressure;
f) spray bottle;
g) bottom outlet to the filter assembly and then to the drain with an on/off valve.
7.1.8 Series of membrane filters and separating gauzes, e.g. cellulose nitrate, polycarbonate.
NOTE Filter sizes with an interior diameter of 50 mm or larger may facilitate the filtration process.
The membrane filters shall be arranged into a series of filters and put in the support in the following
descending order:
a) membrane filter with a nominal pore size of 12 µm;
b) separating gauzes;
c) membrane filter with a nominal pore size of 3 µm;
d) separating gauzes;
e) membrane filter with a nominal pore size of 1,2 µm;
f) separating gauzes (drain side);
g) supporting mesh.
The series of membrane filters shall be mounted in the bottom outlet drain line of the effluent collecting vessel.
7.2 Installation of amalgam separator
7.2.1 Install the amalgam separator in such a way that the flow rate of incoming water can be measured
and regulated. Follow the installation instructions of the manufacturer. The set-up of test apparatus is shown
in Figure 1 and described in 7.1.
NOTE If an integrated air-water separator or auxiliary unit is needed for the amalgam separator to function, as
indicated by the manufacturer, then the additional element is part of the installation of the amalgam separator.
7.2.2 Open the top of the effluent collecting vessel (7.1.7) and put one of the transparent hoses (7.1.6) into
the effluent collecting vessel.
7.2.3 Connect a water cartridge filter (7.1.2) to the water supply of the test set-up. For the test, use tap
water that is directed through the water filter (filtered tap water).
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SIST EN ISO 11143:2008
ISO 11143:2008(E)
7.2.4 The transparent hose (7.1.6) connecting the sample delivery hopper (7.1.4) to the inlet of the
amalgam separator should be positioned as vertically as possible in order to prevent trapping of amalgam
particles.
Care shall be taken to avoid sedimentation of test sample particles outside of the effluent collecting vessel.
7.2.5 The transparent hose connecting the outlet of the amalgam separator to the effluent collecting vessel
shall be positioned with a straight constant slope. The angle of the slope of the transparent hose shall be more
than 30° from the horizontal.
7.2.6 The set-up of test apparatus shall permit the entire amount of the test slurry (8.5) to enter the
amalgam separator.
Key
1 incoming wat
...
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