SIST EN ISO 11143:2000
(Main)Dental equipment - Amalgam separators (ISO 11143:1999)
Dental equipment - Amalgam separators (ISO 11143:1999)
Zahnärztliche Ausrüstung - Amalgamabscheider (ISO 11143:1999)
In dieser Internationalen Norm werden Anforderungen an Amalgamabscheider festgelegt, die zusammen mit der zahnärztlichen Ausrüstung in zahnärztlichen Kliniken Verwendung finden. Der Wirkungsgrad des Abscheiders ergibt sich aus der Menge des zurückgehaltenen Amalgams, basierend auf einer Laborprüfung sowie einem Prüfverfahren zur Ermittlung des Wirkungsgrades. Außerdem werden in dieser Norm Anforderungen an eine sichere Funktionsweise des Abscheiders, an die Kennzeichnung, an die Gebrauchsanweisung und an die Bedienungs- und Wartungsvorschriften festgelegt.
Matériel dentaire - Séparateurs d'amalgame (ISO 11143:1999)
Dental equipment - Amalgam separators (ISO 11143:1999)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11143:2000
01-julij-2000
Dental equipment - Amalgam separators (ISO 11143:1999)
Dental equipment - Amalgam separators (ISO 11143:1999)
Zahnärztliche Ausrüstung - Amalgamabscheider (ISO 11143:1999)
Matériel dentaire - Séparateurs d'amalgame (ISO 11143:1999)
Ta slovenski standard je istoveten z: EN ISO 11143:1999
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 11143:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11143:2000
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SIST EN ISO 11143:2000
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SIST EN ISO 11143:2000
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SIST EN ISO 11143:2000
INTERNATIONAL ISO
STANDARD 11143
First edition
1999-12-01
Dental equipment — Amalgam separators
Matériel dentaire — Séparateurs d'amalgame
Reference number
ISO 11143:1999(E)
©
ISO 1999
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SIST EN ISO 11143:2000
ISO 11143:1999(E)
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SIST EN ISO 11143:2000
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Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Classification.2
5 Requirements.3
6 Sampling.4
7 Test apparatus .4
8 Amalgam sample .7
9 Test procedure.9
10 Test report .12
11 Instructions for installation, use, maintenance and service .13
12 Marking .14
Annex A (informative) Preparation of amalgam sample.15
Annex B (informative) Procedure for grinding the amalgam.18
Annex C (normative) Examination of fraction 3 particles using sedimentation with X-ray absorption.19
Annex D (informative) Particle size distribution of amalgam in dental waste water.21
Bibliography.22
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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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11143 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 6, Dental equipment.
Annex C forms a normative part of this International Standard. Annexes A, B and D are for information only.
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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, filtration, sedimentation or a
combination of any of these methods.
It is recognized 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).
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SIST EN ISO 11143:2000
INTERNATIONAL STANDARD ISO 11143:1999(E)
Dental equipment — Amalgam separators
1 Scope
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 separator, marking, instructions for use, operation and
maintenance.
All tests described in this International Standard are type tests.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 1559:1995, Dental materials — Alloys for dental amalgam.
ISO 3585, Borosilicate glass 3.3 — Properties.
ISO 3696, Water for analytical laboratory use — Specification and test methods.
ISO 9687, Dental equipment — Graphical symbols.
ISO 10076:1991, Metallic powders — Determination of particle size distribution by gravitational sedimentation in a
liquid and attenuation measurement.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
IEC 61010-1:1990, Safety requirements for electrical equipment for measurement, control and laboratory use —
Part 1: General requirements.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions 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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NOTE The amalgam separator may comprise any auxiliary units required for admission of water and the connecting lines
inside the separator, but it does not include the supply and drainage pipes or tubes.
3.2
collecting container
that part of the amalgam separator for retention of separated amalgam waste for the purpose of disposal
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 amalgam sample retained by the amalgam separator
3.5
maximum filling level
level defined by the maximum collecting capacity of the collecting container of the amalgam separator at which the
efficiency is unaffected
3.6
warning level
level, below the maximum filling level, at which the collecting container should be emptied or replaced
3.7
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
3.8
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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5 Requirements
5.1 Efficiency
The efficiency of the amalgam separator shall be at least 95 % (mass fraction) when tested as specified in 9.3 to
9.6.
5.2 Warning system
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 filling level is reached.
Testing shall be carried out in accordance with 9.7.
For type 2 amalgam separators, the warning system requirement can be met if the manufacturer clearly defines
procedures by which the proper function of the amalgam separator is ensured, giving controllable maintenance and
disposal 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 device can perform to the specified efficiency.
The alarm signal shall be activated at the maximum filling level. The alarm signal shall remain activated until the
collecting container and/or filter has been emptied or replaced.
Testing shall be carried out in accordance with 9.8.
For type 2 amalgam separators, the alarm system requirement can be met if the manufacturer clearly defines
procedures by which the proper function of the amalgam separator is ensured, giving controllable maintenance and
disposal procedures as in 11.2. Compliance shall be tested by visual inspection.
5.4 Alarm system for malfunction
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.
Testing shall be carried out in accordance with 9.9.
5.5 Removal of filled collecting container or filter
The collecting container and/or filter shall be capable of being removed easily and safely without discharging any of
the contents into the public sewage system.
The collecting container, filters or separator shall be able to be sealed so that no leakage or spillage can occur
during handling and transportation.
Testing shall be carried out in accordance with 9.10.
5.6 Maximum mass of filled collecting container
When fully loaded, the mass of the removable collecting container or the filters which have to be handled during
emptying shall not exceed 15 kg.
Testing shall be carried out in accordance with 9.11.
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5.7 Electrical safety
If an amalgam separator is electrically powered and is connected as an integral part of the dental unit, it shall
conform to IEC 60601-1. If an amalgam separator is electrically powered and physically remote from the dental unit
but electrically connected, it shall conform to IEC 60601-1. If an amalgam separator is electrically powered and
physically remote but not electrically connected, it shall conform to IEC 61010-1.
Testing shall be carried out in accordance with 9.12.
6 Sampling
All type tests shall be made starting with 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 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�m.
7.1.3 Flowrate meter, for laboratory use, capable of measuring the maximum flowrate stated by the manufacturer
of the amalgam separator and with a tolerance of � 2 % 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 plastics 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.
7.1.7 Effluent collecting vessel, of stainless steel with a polished interior surface, approved 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
flowrate (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 manometer in the range of 0 Pa to 2� 10 Pa, tolerance class 4;
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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 after the filter assembly.
7.1.8 Series of membrane filters and separating gauzes, composed of cellulose nitrate or polycarbonate, each
with an interior circle diameter of at least 50 mm.
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�m;
b) separating gauzes;
c) membrane filter with a nominal pore size of 3�m;
d) separating gauzes;
e) membrane filter with a nominal pore size of 1,2�m;
f) separating gauzes (drain side);
g) supporting mesh.
The series of 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 flowrate 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 air-water separator is needed as indicated by the manufacturer, then the air-water separator is part of the
installation of the amalgam separator.
7.2.2 Open the top of the effluent collecting vessel and put one of the transparent hoses into the effluent collecting
vessel.
7.2.3 Connect a water 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).
7.2.4 The transparent hose connecting the sample delivery hopper to the inlet of the amalgam separator should
be positioned as vertically as possible in order to prevent trapping.
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.
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Key
1 Incoming water
2 Water filter
3 Flowrate meter
4 Sample delivery hopper
5Amalgamseparator
6 Transparent hose
7 Effluent collecting vessel
8 Compressed air
9 Filtered tap water for rinsing
10 Series of filters
11 Drain
12 On/off valve
Figure 1 — Schematic set-up of test apparatus for measuring the efficiency of amalgam separators
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8 Amalgam sample
8.1 Fraction sizes
The amalgam sample for the efficiency test of the amalgam separator (9.3) shall be divided into three differently
sized fractions:
a) Fraction 1: Particle sizeu 3,15 mm and� 0,5 mm.
Ground stock particles which pass through a sieve with 3,15 mm nominal aperture size and which are
collected by a sieve with 0,5 mm nominal aperture size.
b) Fraction 2: Particle sizeu 0,5 mm and� 0,1 mm.
Ground stock particles which pass through a sieve with 0,5 mm nominal aperture size and which are collected
by a sieve with 0,1 mm nominal aperture size.
c) Fraction 3: Particle sizeu 0,1 mm.
Ground stock particles which pass through a sieve with 0,1 mm nominal aperture size.
8.2 Mass of amalgam sample
The total mass of the amalgam sample shall be 10,00 g, made from the three particle fractions described in 8.1 as
follows:
6,000 g (60 % mass fraction) particles of fraction 1;
1,000 g (10 % mass fraction) particles of fraction 2;
3,000 g (30 % mass fraction) particles of fraction 3.
NOTE This mean particle size distribution was calculated from particle size distributions of amalgam in dental waste water
based on investigatons of the American, Dutch and German Dental Associations (see annex D and annex E, [11], [12], [13]).
The mass of the three fractions shall be measured to an accuracy of three decimal places. If the production of the
mass of particles of fraction 1 is only possible with mass deviations greater than 0,01 g, then the mass amounts of
the other two fractions shall be changed in such a way that the ratios of mass fraction are preserved.
8.3 Sample preparation
For the preparation of the amalgam sample, capsules predosed with alloy and mercury conforming to the chemical
composition specified in ISO 1559 shall be used.
NOTE Annex A of this International Standard describes a procedure for preparation of the amalgam sample.
8.4 Particle size distribution
8.4.1 For fractions 1 and 2, the particle size distributions shall be within the limits described in 8.2.
8.4.2 For fraction 3, the cumulative mass distribution of amalgam particles shall be in accordance with Figure 2.
For fraction 3 particles, the sedimentation X-ray absorption technique in accordance with annex C of this
International Standard shall be used as the examination procedure.
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Key
1 Tolerance of � 2 % for particles � 5�m
2 Tolerance of � 5 % for particlesW 5 �m
Figure 2 — Cumulative mass distribution (average and 99 % forecasting area) of fraction 3 amalgam particles
with diameter of less than 100����m
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8.5 Preparation of test slurry
8.5.1 Apparatus and materials
8.5.1.1 Scales, with a measuring range of 0,01 g to 10 g and a measuring accuracy of � 0,000 1 g.
8.5.1.2 Glass beaker of borosilicate, minimum capacity 1,2 l, with an internal diameter of at least 70 mm,
conforming to ISO 3585.
8.5.1.3 Stirring rod.
8.5.1.4 Ultrasonic bath.
8.5.1.5 Sodium pyrophosphate,Na P O , Technical Grade, 1 g.
4 2 7
8.5.1.6 Filtered tap water, filtered with a water filter such as 7.1.2.
8.5.2 Procedure
8.5.2.1 Use the amalgam sample prepared in accordance with 8.2.
8.5.2.2 Weigh the dry amalgam sample to an accuracy of three decimal places and note the mass m in grams.
1
8.5.2.3 Put the amalgam sample into the glass beaker (8.5.1.2).
8.5.2.4 Prepare the dispersing agent solution by mixing (1� 0,1) g of sodium pyrophosphate (8.5.1.5) with
(10� 0,1) ml of filtered tap water. Filter the solution through a 1�m pore size filter. Add the filtered dispersing agent
to the glass beaker containing the amalgam test sample. Stir the slurry with a stirring rod (8.5.1.3) until all amalgam
particles are completely wetted by the dispersing agent.
NOTE Sodium pyrophosphate prevents air bubbles from sticking to the dispersed amalgam.
8.5.2.5 Fill the glass beaker with additional filtered tap water up to a volume of (1 � 0,05) l and put it into an
ultrasonic bath (8.5.1.4) for (15� 1) min to disperse the remaining agglomerate. During this process, stir
periodically by hand in order to avoid sedimentation of the amalgam.
9 Test procedure
9.1 General
All tests described in this International Standard are type tests. The type tests shall be carried out on one
representative sample of the item being tested.
9.2 Preconditioning
Before testing is started, the equipment shall be kept in the testing location unoperated for at least 24 h. All testing
shall be carried out at a room temperature of (23� 2) °C. If the amalgam separator requires electricity for operation,
before the actual series of tests, operate the equipment at rated voltage in accordance with the instructions for use.
9.3 Efficiency test
9.3.1 Apparatus
9.3.1.1 Test apparatus as specified in clause 7.
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9.3.1.2 Glass beaker of borosilicate, minimum capacity of 1,2 litre.
9.3.1.3 Spray bottle.
9.3.1.4 Ceramic tile.
9.3.1.5 Oven or drying cabinet, capable of being maintained at (90� 2) °C.
9.3.1.6 Desiccator.
9.3.1.7 Scales, with an appropriate measuring range and an accuracy of � 0,000 1 g.
9.3.2 Test method
9.3.2.1 Test the amalgam separator in the test apparatus set up in accordance with 7.1.
9.3.2.2 Before the measurement, dry the series of filters (7.1.8) in a drying oven at (30� 2) °C for at least 3 h to a
constant mass. Cool the series of filters to room temperature in a desiccator. Weigh the series of filters to an
accuracy of three decimal places. Return the series of filters to the desiccator. After 24 h reweigh the series of
filters. If the result is consistent, record the mass m in grams.
2
Prepare the series of filters (7.1.8) and fix them in the outlet of the effluent collecting vessel.
9.3.2.3 Open the water inlet and conduct the test at the maximum water flowrate as specified by the manufacturer,
reduced by 0,5 l/min to compensate for the water of the test slurry.
Ensure that all water passing through the amalgam separator is collected in the effluent collecting vessel (7.1.7).
9.3.2.4 Stir the test slurry (8.4).
Carefully pour the test slurry evenly without stopping, over a period of (120� 10) s while stirring constantly, into the
sample delivery hopper, adding it to the water flowing into the amalgam separator.
NOTE 1 The water of the test slurry (approximately 1 l over 2 min) is part of the maximum water flowrate.
NOTE 2 It is important to pour the test slurry as evenly as possible into the sample delivery hopper, resulting in the same flow
of test slurry over the entire 120 s.
Rinse the glass beaker with (0,1� 0,01) l filtered water from the spray bottle [7.1.7 f)] until the glass beaker is
visibly free from residue.
Flush the sample delivery hopper with the filtered tap water which flows into the delivery hopper until all visible
residue is removed from the delivery hopper walls. Remove the sample delivery hopper.
9.3.2.5 Increase the water flowrate to the maximum water flowrate as specified by the manufacturer. Stop the
water flow 8 min after the end of the addition of the test sample in order to include in the measurements any
possible flush-out of sample already sedimented in the amalgam separator. For amalgam separators of type 2, if
the total volume is less than 10 l, it is essential that the volume of water flow for this procedure be at least twice the
amalgam waste-water volume of the amalgam separator.
9.3.2.6 Close the valve for the incoming water and remove the transparent hose from the effluent collecting
vessel. Put the top on the effluent collecting vessel and secure it. Open the drain. Apply an air pressure of
5 5
1,5� 10 Pa to 2� 10 Pa to the effluent collecting vessel in order to force the fluid through the series of filters.
Wait until all water has flowed out of the effluent collecting vessel. Close the air pressure valve. Open the inlet to
the rinse water. Rinse the interior walls of the effluent collecting vessel using approximately 1 l filtered tap water.
5 5
Close the inlet to the rinse water. Again apply an air pressure of 1,5� 10 Pa to 2� 10 Pa to the effluent collecting
vessel to ensure that all remains are forced against the series of filters. Again rinse the interior walls of the effluent
collecting vessel with filtered tap water to ensure that no residue sticks to the interior walls of the effluent collecting
vessel. Apply the air pressure again and finally rinse the interior walls.
Repeat the described procedure two times.
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9.3.2.7 Carefully remove the series of filters, put them on a ceramic tile, store them in the drying oven and dry
them at (90� 2) °C for at least 3 h to constant mass. Cool the ceramic tile and the series of filters with their
contents to room temperature in a desiccator. Weigh the series of filters to an accuracy of three decimal places.
Return the series of filters to the
...
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