Dental equipment - Mercury and alloy mixers and dispensers (ISO 8282:1994)

Specifies requirements and test methods for devices used for dispensing dental amalgam alloys and/or mercury. Includes the dispensing portion of devices which dispense the correct portions of alloy and mercury as well as mix the amalgam in a single, continuous operation. Does not specify requirements and test methods for the efficacy of mixing.

Zahnärztliche Ausrüstung - Mischgeräte und Dosierer für Quecksilber und Legierungen zur Herstellung von Amalgam (ISO 8282:1994)

Matériels dentaires - Mélangeurs et distributeurs de mercure et d'alliages (ISO 8282:1994)

La présente Norme internationale prescrit les exigences et les méthodes d'essai relatives aux appareils utilisés pour la distribution de mercure et/ou d'alliages pour amalgame dentaire. Elle inclut l'élément doseur distributeur des appareils qui permettent de distribuer l'alliage et le mercure en portions correctes et de mélanger l'amalgame en une seule opération continue. Elle ne prescrit ni les exigences, ni les méthodes d'essai relatives à l'efficacité du mode opératoire de mélange.

Dental equipment - Mercury and alloy mixers and dispensers (ISO 8282:1994)

General Information

Status
Published
Publication Date
31-Dec-1999
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jan-2000
Due Date
01-Jan-2000
Completion Date
01-Jan-2000

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EN ISO 8282:2000
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SLOVENSKI STANDARD
SIST EN ISO 8282:2000
01-januar-2000
Dental equipment - Mercury and alloy mixers and dispensers (ISO 8282:1994)
Dental equipment - Mercury and alloy mixers and dispensers (ISO 8282:1994)
Zahnärztliche Ausrüstung - Mischgeräte und Dosierer für Quecksilber und Legierungen
zur Herstellung von Amalgam (ISO 8282:1994)
Matériels dentaires - Mélangeurs et distributeurs de mercure et d'alliages (ISO
8282:1994)
Ta slovenski standard je istoveten z: EN ISO 8282:1997
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 8282:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8282:2000

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SIST EN ISO 8282:2000

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SIST EN ISO 8282:2000

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SIST EN ISO 8282:2000

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SIST EN ISO 8282:2000

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SIST EN ISO 8282:2000
INTERNATIONAL Is0
STANDARD
8282
First edition
1994-l o-01
Dental equipment - Mercury and alloy
mixers and dispensers
Ma thriels den taires - Mtilangeurs et distributeurs de mercure et
d ‘alliages
Reference number
IS0 8282:1994(E)

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SIST EN ISO 8282:2000
IS0 $282: 1994(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
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. IS0
collaborates closely with the International Electrotechnical Commission
(I EC) on all matters of electrotechnical standardization.
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.
International Standard IS0 8282 was prepared by Technical Committee
lSO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.
0 IS0 1994
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 m CH-1211 Geneve 20 0 Switzerland
Printed in Switzerland

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SIST EN ISO 8282:2000
INTERNATIONAL STANDARD 0 IS0 IS0 8282: 1994(E)
- Mercury and alloy mixers and
Dental equipment
dispensers
Combination alloy/mercury dis-
1 Scope Type 3
pensers
This International Standard specifies requirements
Category 1 Alloy powder
and test methods for devices used for dispensing
Category 2 Alloy tablet
dental amalgam alloys and/or mercury. It includes the
Category 3 Adjustable volume alloy and/or
dispensing portion of devices which dispense the
mercury
correct portions of alloy and mercury as well as mix
the amalgam in a single, continuous operation. Dispensing and mixing devices
Type 4
It does not specify requirements and test methods for
4 Requirements
the efficacy of mixing.
4.1 Construction
2 Normative reference
Dispensers shall not exhibit any defects such as
cracks or missing adhesive which could lead to failure
The following standard contains provisions which,
through reference in this text, constitute provisions of the dispenser during normal usage resulting in a
sudden release of mercury or alloy.
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All standards
Dispensers shall be made of materials that do not re-
are subject to revision, and parties to agreements
act with or contaminate the alloy or mercury. No de-
based on this International Standard are encouraged
terioration of the surface of the reservoir shall be
to investigate the possibility of applying the most re-
visible after the test and no visible change in the alloy
cent edition of the standard indicated below. Mem-
or mercury is acceptable.
bers of IEC and IS0 maintain registers of currently
valid International Standards.
Testing shall be in accordance with 6.1 and 6.2.
IS0 1560: 1985, Dental mercury.
4.2 Adjustment
Adjustable dispensers shall be provided with a means
3 Classification
of ensuring that the adjustment will not change during
normal use.
Dispensers covered by this International Standard
shall be classified as follows:
Testing shall be in accordance with 6.1.
Alloy dispensers
Type 1
4.3 Mercury leakage
Category 1 Powder
Category 2 Tablet
Mercury dispensers shall not exhibit a static leakage
exceeding 1 mg.
Mercury dispensers
Type 2
Fixed volume
Category 1
NOTE 1 While 1 mg leakage is currently acceptable, the
Adjustable volume
Category 2 goal is to reach zero leakage in the near future.

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SIST EN ISO 8282:2000
0 IS0
IS0 8282:1994(E)
deposited during function after 100
Mercury leakage
5 Sampling
not exceed 0,lO g.
dispensings shall
One sample of the device shall be procured on the
For devices of type 4 no mercury should be visible
open market for testing for compliance with this
after 100 dispensings in the interior of the dispensing
International Standard.
and mixing device except the mercury container, the
connecting tube and the capsule.
6 Test methods
Testing shall be in accordance with 6.3.
6.1 Visual inspection
4.4 Filling
Visually inspect the test piece at normal visual acuity
The device shall be capable of being filled with mer- without magnification to determine compliance with
cury without spillage. the stated requirements.
Testing shall be in accordance with 6.4.
6.2 Construction
Fill the reservoirs for mercury and alloy to the maxi-
4.5 Accuracy and performance
mum level and empty after 24 h. Conduct the tests
of 6.3 to 6.6, and leave the device for a further 24 h.
4.51 Mercury and/or alloy powder dispe
Then examine the alloy and mercury for visible
changes and test the mercury for compliance with the
At each dispensing the mass of mercury or alloy
requirements of IS0 1560. Empty the reservoirs and
powder shall fall within + 3 % for powder and
-
clean them according to the manufacturer ’s in-
+ I,5 % for mercury of the value claimed by the
-
structions.
manufacturer.
Visually examine the surfaces and note any deterio-
Testing shall be in accordance with 6.5.1.
rations.
4.52 Alloy tablet dispensers
6.3 Mercury leakage
In addition
...

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