SIST EN ISO 11498:2000
(Main)Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
Gives requirements and test methods for dental low-voltage electrical motors used in connection with dental handpieces. It also contains specifications on manufacturer's instructions, packaging and marking. Refers to IEC 601-1, the basic standard on safety of medical electrical equipment.
Zahnärztliche Handstücke - Zahnärztliche elektrische Kleinspannungsmotoren (ISO 11498:1997)
Diese Internationale Norm legt Anforderungen und Prüfmethoden für zahnärztliche elektrische Kleinspannungsmotoren, betrieben in Verbindung mit zahnärztlichen Handstücken, zur Anwendung an Patienten fest. Sie enthält auch Festlegungen für Herstelleranweisungen, Verpackung und Kennzeichnung. Alle Prüfungen dieser Internationalen Norm sind Typprüfungen. Zahnärztliche elektrische Kleinspannungsmotoren werden von zahnärztlichen Behandlungsgeräten aus betrieben oder als unabhängiges bewegliches Teil. Sie werden für den Betrieb von zahnärztlichen geraden und winklig angetriebenen Handstücken gebraucht.
Pieces a main dentaires - Moteurs électriques dentaires a basse tension (ISO 11498:1997)
IEC 62005-9-4:2018 traite des exigences de qualification de fiabilité de composants optiques passifs en ce qui concerne leur utilisation dans des applications à puissance optique élevée pour la catégorie environnementale C.
Mots clés: l'assurance de la fiabilité à puissance optique élevée, catégorie environnementale C
Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11498:2000
01-januar-2000
Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
Zahnärztliche Handstücke - Zahnärztliche elektrische Kleinspannungsmotoren (ISO
11498:1997)
Pieces a main dentaires - Moteurs électriques dentaires a basse tension (ISO
11498:1997)
Ta slovenski standard je istoveten z: EN ISO 11498:1999
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
29.160.30 Motorji Motors
SIST EN ISO 11498:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11498:2000
INTERNATIONAL IS0
STANDARD 11498
First edition
1997-02-I 5
Dental handpieces - Dental low-voltage
electrical motors
Pi&es 2 main dentaires - Moteurs klectriques dentaires ti basse tension
Reference number
IS0 11498: 1997(E)
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SIST EN ISO 11498:2000
IS0 11498: 1997(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 (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 International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard IS0 11498 was prepared by Technical Committee lSO/TC 106, Dentistry, Subcommittee
SC 4, Dental instruments.
0 IS0 1997
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 l CH-1211 Geneve 20 l Switzerland
Internet central @ iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 11498:2000
IS0 11498:1997(E)
INTERNATIONAL STANDARD o IS0
Dental handpieces - Dental low-voltage electrical motors
1 Scope
This International Standard specifies requirements and test methods for dental low-voltage electrical motors used in
connection with dental handpieces for application on patients. It also contains specifications on manufacturer’s
instructions, packaging and marking. All tests described in this International Standard are type tests.
Dental low-voltage electrical motors are operated by dental units or as independent mobile devices. They are used
for straight and geared angle handpieces.
This International Standard takes priority over IEC 601-I:1988 as specified in the individual clauses of this
International Standard.
Only the specifications laid down in this International Standard are applicable.
This International Standard refers to IEC 601-1, the basic standard on safety of medical electrical equipment,
wherever relevant, by stating the respective clause numbers of IEC 601-I :I 988.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
IS0 554:1976, Standard atmospheres for conditioning and/or testing - Specifications.
IS0 1942-3: 1989, Dental vocabulary - Part 3: Den?al instruments.
- Specification and test methods.
IS0 3696:1987, Water for analytical laboratory use
IS0 3964:1982, Dental handpieces - Coupling dimensions.
IS0 4211 :I 979, Furniture - Assessment of surface resistance to cold liquids.
IS0 7494:1996, Dental units.
- Part 2: Straight and geared angle handpieces.
IS0 7785-2:1995, Dental handpieces
IS0 9687: 1993, Dental equipment - Graphical symbols.
IS0 13402:1995, Surgical and dental hand instruments - Determination of resistance against autoclaving,
corrosion and thermal exposure.
IEC 601-I :I 988, Medical electrical equipment - Part 1: General requirements for safety.
IEC 601-I -2:1993, Medical electrical equipment - Part I: General requirements for safety - Part 2: Electromagnetic
compatibility of medical electrical equipment and/or systems.
IEC 651 :I 979, Sound level meters.
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SIST EN ISO 11498:2000
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IS0 11498: 1997(E)
3 Definitions
For the purposes of this International Standard, the definitions given in IS0 1942-3 and in IEC 601-1:1988, clause 2,
apply.
4 Classification
4.1 Ranae of free-runnina meed
J I
J
Dental low-voltage electrical motors can be classified by their free-running speed range in accordance with table 1.
Table 1 - Classification of motor
Speed range
Type
r/min
1 up to 20 000
2 4 000 to 40 000
3 4 000 to over 40 000
4.2 Type of protection against electric shock
Dental low voltage electrical motors are classified as Class II equipment, in which protection against electric shock
does not rely on basic insulation only, but in which additional safety precautions such as double insulation or
reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation
conditions.
4.3 Degree of protection against electric shock
Dental low-voltage electrical motors shall be grouped as either Type B or Type BF equipment (Type B equipment
with an F-type isolated (floating) applied part).
4.4 Operating conditions
4.4.1 Intermittent operation
Dental low-voltage electrical motors are a type of dental equipment which is operated intermittently.
4.4.2 Environment
Dental low-voltage electrical motors shall not be used in the presence of a flammable anaesthetic gas mixed with air
or with oxygen or nitrous oxide.
5 Requirements
5.1 General
5.1 .l Construction
The dental low-voltage electrical motor shall be constructed to provide safe and reliable operation and, if reparable
on site, should be capable of being easily disassembled and reassembled for maintenance and repair, using readily
available tools or those supplied by the manufacturer.
2
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SIST EN ISO 11498:2000
IS0 11498:1997(E)
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5.1 .I .l Mechanical strength
If not otherwise described by the manufacturer, the dental low-voltage electrical motor shall not incur damage such
that its safety is no longer warranted as a result of a free fall from a height of 1 m onto a plain smooth ceramic floor
surface.
Testing shall be carried out in accordance with 7.3.1 and, if applicable, IEC 6Ol-1:1988, clause 21.5.
5.1 .1.2 Surfaces, corners and edges
There shall be no uncovered rough surfaces, sharp corners or edges which may cause injury or damage.
Verification shall be carried out visually (7.3.1).
51.2 Power connection
The dental low-voltage electrical motor shall be capable of being easily disconnected from and reconnected to the
power supply.
The service shall be supplied from a dental unit complying with IS0 7494.
Testing shall be carried out in accordance with 7.3.2.
5.1.3 Operating controls
5.1.3.1 General
Operating controls shall be designed and located to minimize unintentional activation.
Graphical symbols for operating controls and functions shall be in accordance with IS0 9687.
Verification shall be carried out visually (7.3.1)
5.1.3.2 Speed
The dental low-voltage electrical motor, or dental low-voltage electrical motor connected to a dental unit, shall be
provided with operating controls to change the speed as described by the manufacturer.
Verification shall be carried out visually (7.3.1)
5.1.3.3 Direction of rotation
The dental low-voltage electrical motor, or dental low-voltage electrical motor connected to a dental unit, shall be
provided with operator controls to allow clockwise and anticlockwise rotation as described by the manufacturer.
The controls shall be located on the dental low-voltage electrical motor itself or on the dental unit.
Verification shall be carried out visually (7.3.1)
5.1.4 Disinfection and cleaning
All accessible exterior parts of the dental low-voltage electrical motor shall be capable of undergoing surface
disinfection and cleaning without causing deterioration of the motor’s surface or markings, using agents
recommended by the manufacturer.
Testing shall be carried out in accordance with 7.2.7.
5.1.5 Sterilizability
If applicable, the accessible exterior surfaces of the dental low-voltage electrical motor shall be sterilizable. Testing
shall be carried out according to the manufacturer’s instructions. The surfaces shall withstand a minimum of 250
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SIST EN ISO 11498:2000
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IS0 11498: 1997(E)
cycles under the manufacturer’s recommended sterilizing procedure without visible exterior signs of deterioration
and no greater than 10 % reduction in motor shaft power.
NOTE - This test is not a test of service lifetime.
Testing shall be carried out in accordance with the manufacturer’s instructions.
5.1.6 Temperature limits
5.1.6.1 Excessive temperatures
The requirements given in IEC 601-I :I 988, clause 42 apply.
5.1.6.2 Temperature increase of housing
The temperature at the accessible exterior surfaces of the motor housing under no-load running conditions shall not
exceed that of the ambient environment by more than 20 “C.
Testing shall be carried out in accordance with 7.2.8.
5.1.7 Corrosion resistance
The accessible exterior surfaces of the dental low-voltage electrical motor shall be corrosion-resistant as specified
from the manufacturer, i.e. the materials used shall show no visible signs of corrosion after being subjected to
autoclaving.
Testing shall be carried out in accordance with 7.2.9.
5.2 Operating requirements and recommendations
5.2.1 Spray water supply
If applicable, the dental low-voltage electrical motor shall supply equipment to transmit water to the dental
handpiece (in accordance with IS0 7785-2). The equipment shall be capable of attaining a maximum water flowrate
of a least 50 mI/min at 250 kPa (2,5 bar).
Testing shall be carried out in accordance with 7.3.3.
5.2.2 Spray air supply
If applicable, the dental low-voltage electrical motor shall supply equipment to transmit air to the dental handpiece
(in accordance with IS0 7785-2). The equipment shall be capable of attaining an air flowrate of at least I,5 I/min.
Testing shall be carried out in accordance with 7.3.4.
5.2.3 Motor cooling air
If the dental low-voltage electrical motor is equipped with an air cooling system, the maximum air flowrate should be
40 Vmin and the pressure range should be between 250 kPa to 500 kPa (2,5 bar to 5,0 bar).
The dental low-voltage electrical motor shall have an outlet connection for the motor air cooling.
Testing shall be carried out in accordance with 7.3.5.
5.2.4 Handpiece connector
to the dental low-voltage electrical
The configuration, dimensions and tolerances of the dental handpiece connector
motor should comply with IS0 3964.
able measuring instruments.
Testing shall be carried out by inspection and measurement by using readily avai
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5.2.5 Light supply
If the dental low-voltage electrical motor is equipped with a light supply system, this shall be described by the
manufacturer.
Testing shall be carried out by inspection and measurement, using readily available measuring instruments.
5.2.6 Free-running speed
The free-running speed range of the dental low-voltage electrical motor shall be in accordance with the
manufacturer’s declaration, with a tolerance of + IO % for both clockwise and anticlockwise directions.
Testing shall be carried out in accordance with 7.3.6.
5.2.7 Rotation
The dental low-voltage electrical motor should be capable of clockwise and anticlockwise rotation as described by
the manufacturer.
Verification shall be carried out visually (7.3.1).
5.2.8 Torque
The generated torque shall be more than 0,Ol N-m for Types 1 and 2 motors; the generated torque shall be more
than 0,02 Nom for Type 3.
Testing shall be carried out in accordance with 7.3.7.
5.2.9 Noise level
The A-weighted sound pressure value generated by the dental low-voltage electrical motor shall not exceed 75 dB.
NOTE - It is recommended to reduce the A-weighted noise level to 65 dB.
Testing shall be carried out in accordance with 7.3.8.
5.3 Electrical requirements
5.3.1 Power input and supply voltage
The requirements given in IEC 601-1:1988, clause 7, apply.
Voltage shall not exceed a nominal value of 25 V a.c or 60 V d.c. at rated supply voltage on the transformer or
converter, between conductors in an earth-free circuit which is isolated from the supply mains by a safety
transformer or by a device with an equivalent separation.
Testing shall be carried out in accordance with 7.4.1.2.
5.3.2 Single fault conditions
The requirements given in IEC 601-1:1988, clause 3.6. apply.
5.3.3 Protection against electric shock hazards
The requirements given in IEC 601-1:1988, clause 13 apply.
5.3.4 Requirements related to classification (see clause 4)
5.3.4.1 Class II equipment
The requirements given in IEC 601-I :I 988, clause 14.2 apply.
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IS0 11498: 1997(E)
5.3.4.2 Type B and BF
The requirements given in IEC 601-I :I
...
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