EN ISO 7488:1995
(Main)Dental amalgamators (ISO 7488:1991)
Dental amalgamators (ISO 7488:1991)
Deals with the safety of electric battery chargers for household use having an output at safety extra-low voltage, their rated voltage being not more than 250 V. This standard also includes battery chargers intended for use in garages, shops, light industry and on farms.
The contents of the corrigendum of November 2004 have been included
in this copy.
This consolidated version consists of the fourth edition (2002) and its amendment 1 (2004). Therefore, no need to order amendment in
addition to this publication.
Zahnärztliche Amalgamatoren (ISO 7488:1991)
Die vorliegende Internationale Norm legt die Anforderungen, Prüfmethoden für die Bestimmung der Einhaltung dieser Anforderungen und Einzelheiten für die Kennzeichnung elektrisch angetriebener Amalgammischer fest, die geeignet sind Amalgamlegierungen und Quecksilber für zahnärztliche Amalgame zu mischen. Sie liefert Methoden, um die Gleichförmigkeit der Arbeitsweise und der Leistung dieser Amalgamatoren zu überprüfen und sie soll die Reproduzierbarkeit des Amalgamiervorgangs sichern.
Amalgamateurs dentaires (ISO 7488:1991)
La présente Norme internationale prescrit les spécifications, les méthodes d'essai à employer pour déterminer la conformité à ces spécifications, ainsi que des indications pour le marquage des appareils électriques opérant des mélanges et qui conviennent pour mélanger l'alliage pour amalgame dentaire et le mercure pour amalgame dentaire. Elle donne des méthodes permettant de comparer l'uniformité de fonctionnement ainsi que l'aptitude à l'emploi de ces amalgamateurs et prévoit d'assurer la reproductibilité de l'amalgamation.
Dental amalgamators (ISO 7488:1991)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
Dental amalgamators (ISO 7488:1991)
Dental amalgamators (ISO 7488:1991)
Zahnärztliche Amalgamatoren (ISO 7488:1991)
Amalgamateurs dentaires (ISO 7488:1991)
Ta slovenski standard je istoveten z: EN ISO 7488:1995
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
IS0
INTERNATIONAL
STANDARD 7488
First edition
1991-06-01
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Dental amalgamators
Amalgamateurs dentaires
_____-._ ---- ~---
Reference number
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___ ______ -_.-.-- ---- IS0 7488:1991(E)
IS0 7488:1991(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, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) 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 lnter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard IS0 7488 was prepared by Technical Committee
ISO/TC 106, Dentistry.
0 IS0 1991
All rights reserved. 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 l CH-1211 Genbve 20 l Switzerland
Printed in Switzerland
ii
IS0 7488:1991(E)
Introduction
Electrically powered amalgamators are machines used primarily for
mixing (trituration) of amalgam alloys and mercury to produce dental
amalgams but they may also be used for mixing other dental materials.
In many amalgamators a removable capsule is used to contain the alloy
and mercury. Although the capsule must be considered as part of the
amalgamator when in use or under test, the requirements for capsules
are not dealt with in this International Standard; they may be the subject
of a separate Standard.
Some amalgamators may incorporate a mechanism for dispensing the
alloy or mercury or both. These devices may be subjected to the test in
this International Standard except for the dispensing stage.
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INTERNATIONAL STANDARD IS0 7488:1991 (E)
Dental amalgamators
when t he capsule is in its normal working or “acti-
1 Scope
vated” configuration.
This International Standard specifies requirements,
3.3 amplitude of capsule motion: Range of move-
test methods to determine compliance with these
ment, in millimetres, of the midpoint of the capsule
requirements and details of marking of electrically
measured in the direction of the
while running,
powered mixing amalgamators suitable for mixing
working length.
dental amalgam alloy and mercury for dental
amalgams.
4 Classification
It provides methods of comparing uniformity of op-
eration and performance of these amalgamators
Amalgamators are classified as follows:
and is intended to ensure reproducibility of amal-
gamation.
Type 1: Fixed frequency
Type 2: Variable frequency
2 Normative reference
The following standard contains provisions which,
5 Requirements
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
5.1 Electrical safety
cation, the edition indicated was valid. All standards
are subject to revision, and parties to agreements
Amalgamators shall comply as regards the elec-
based on this International Standard are encour-
trical requirements and the testing with the relevant
aged to investigate the possibility of applying the
clauses of IEC 335-l.
most recent edition of the standard indicated below.
Members of IEC and IS0 maintain registers of cur-
NOTE 2 Compliance with IEC 335-l is required pending
rently valid International Standards.
development and publication of IEC requirements for lab-
oratory and related equipment.
IEC 335-1:1976, Safety of household and similar elec-
trical appliances - Part I: General requirements.
5.2 Mechanical safety
3 Definitions
5.2.1 The amalgamator shall have an enclosure
that will contain a capsule, its contents, or a ma-
of this International Standard, the
For the urposes
P
chine part that may become dislodged or broken
followin definitio ns apply.
g
during use.
3.1 coherence: State when all the alloy and the
5.2.2 Moving parts with which the user may
mercury are combined in a single unified mass.
normally be expected to come into contact shall be
free from rough or sharp edges and corners.
NOTE 1 Small cracks or a dry looking surface do not
detract from coherence.
5.2.3 In addition, the following requirements shall
3.2 working length of capsule: Maximum internal
apply*
dimension lying parallel to the direction of the
greatest motion or, where uniform circular motion a) During normal operation, insertion, or removal,
applies, the greatest internal dimension parallel to the capsule shall not be damaged in such a way
a principal axis of the capsule in the plane of motion as to allow leakage of mercury.
IS0 7488:1991(E)
5.52 Timing settings
b) The capsule shall be securely and firmly retained
during operation of the amalgamator at the
highest power recommended by the manufac- The timing device may provide continuously variable
turer [see clause 8e)]. settings or settings in steps. The intervals produced
shall be accurate to +5 % of the nominal value of
c) The position of the capsule shall be definite and the setting or +0,5 s whichever is the larger: the
intervals shall &o be reproducible within +2 % of
reproducible.
the actual value of the setting or +0,2 s whichever
Testing shall be carried out in accordance with 7.2.
is the larger. These provisions shall further apply
when the machine is subjected individually to supply
voltage variation of + 5 % at the rated voltage, or if
5.3 Capsule oscillation frequency
a supply voltage range is given, variation of the
voltage over the stated range.
53.1 General
Testing shall be carried out in accordance with 7.5.
The operating frequency of the amalgamator shall
not vary by more than +2 Hz at any frequency set-
5.6 Coherence
ting during any run of not less than 15 s or the
maximum duration recommended by the manufac-
The amalgamator shall operate in a manner that will
turer for that setting when subjected individually to
cause the amalgam to display coherence in any and
each of the following:
all capsules and alloys, recommended for use by the
manufacturer, in less time than the manufacturer
a) variation of the supply voltage by + 5 % of the
-
recommends for trituration.
rated voltage, or if a supply voltage range is
given, variation of the voltage throughout the Testing shall be carried out in accordance with 7.2.
stated range;
5.7 Stability
b) variation of the mass of the capsule and con-
tained alloy and mercury within the ranqe rec-
\
While running for the maximum duration rec-
ommended by the manufacturer;
ommended by the manufacturer at any frequency
setting, the machine shall not move more than 5 mm
c) three immediately successive mixing operations
across the glass surface.
for the maximum duration recommended by the
manufactu
...
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