SIST EN ISO 9680:2000
(Main)Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995)
Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995)
Zahnärztliche Behandlungsleuchte (ISO 9680:1993, einschließlich Technische Korrektur 1:1995)
Diese Internationale Norm gilt für zahnärztliche Arbeitsfeldleuchten wie immer sie konstruiert sind, die zur Beleuchtung der Mundhöhle verwendet werden.Sie legt Anforderungen und Prüfmethoden fest. Sie enthält auch Festlegungen für Herstelleranweisungen, Kennzeichnung und Verpackung.
Appareil d'éclairage opératoire dentaire (ISO 9680:1993, Rectificatif Technique 1:1995 inclus)
Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9680:2000
01-januar-2000
Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995)
Dental operating light (ISO 9680:1993, including Technical Corrigendum 1:1995)
Zahnärztliche Behandlungsleuchte (ISO 9680:1993, einschließlich Technische Korrektur
1:1995)
Appareil d'éclairage opératoire dentaire (ISO 9680:1993, Rectificatif Technique 1:1995
inclus)
Ta slovenski standard je istoveten z: EN ISO 9680:1996
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 9680:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
INTERNATIONAL
IS0
STANDARD
9680
First edition
1993-l O-l 5
Dental operating light
Appareil d ‘Mairage op&a toire den taire
Reference number
IS0 9680:1993(E)
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SIST EN ISO 9680:2000
IS0 9680:1993(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 9680 was prepared by Technical Committee
ISO/TC 106, Dentistry, Sub-Committee SC 6, Dental equipment.
0 IS0 1993
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 per-
mission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
Introduction
This International Standard contains specifications on the lighting of the
dental surgery and its associated areas, and of the dental laboratory.
The aim is to provide the dentist and his staff with means to enable them
to work with optimum visual ease and comfort, i.e. a visual acuity of
90 % to 100 % according to zone, without adversely affecting their per-
ception of colour or causing excessive fatigue.
In this International Standard, the safety of a dental operating light is as-
sessed in combination with its power supply. Such power supplies may
be incorporated in dental units or dental patient chairs.
Any item of equipment recommended by the manufacturer for use in
conjunction with a dental operating light should not render the equipment
unsafe.
In preparing this International Standard account has been taken of
IEC 598-l.
1 as specified in the
This International Standard takes priority over IEC 601.
individual clauses of this International Standard.
Only the specifications laid down in this lnternationa Standard are appli-
cable.
601-1, the basic sta ndard on safety
Thi s Intern ational Standard refer to IEC
statin g the re-
of medica I elect rical equi pment, whe rever relevant,
bY
spective clause numbers of IEC 601-I.
It also contains specifications on manufacturer’s instructions, marking and
packaging.
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SIST EN ISO 9680:2000
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
INTERNATIONAL STANDARD
Dental operating light
3 Definitions
1 Scope
For the purposes of this International Standard, the
This International Standard applies to dental operating
definitions given in IS0 1942-4 and the following
lights, however constructed, used for illuminating the
definitions apply.
oral cavity. Its specifies requirements and test meth-
ods. It also contains specifications on manufacturer’s
3.1 luminaire: Apparatus which distributes, filters
instructions, marking and packaging.
or transforms the light transmitted from one or more
lamps and which includes all parts necessary for sup-
porting, fixing and protecting the lamps, but not the
2 Normative references
and where necessary circuit
lamps themselves,
auxiliaries together with the means of connecting
The following standards contain provisions which,
them to the supply. [IEC 598-l :I9861
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
3.2 lamp: Light source.
cation, the editions indicated were valid. All standards
are subject to revision, and parties to agreements
3.3 dental luminaire: Luminaire specially designed
based on this International Standard are encouraged
and/or presented for use in the dental surgery.
to investigate the possibility of applying the most re-
cent editions of the standards indicated below.
3.4 dental operating light: Item of equipment spe-
Members of IEC and IS0 maintain registers of cur-
cially designed for use by a dentist for illuminating the
rently valid International Standards.
oral cavity, consisting of a dental Iuminaire and one
or more lamps.
IS0 1942-4: 1989, Dental vocabulary - Part 4: Dental
equipment.
4 Classification
IS0 4211: 1979, Furniture - Assessment of surface
resistance to cold liquids.
4.1 According to type of protection against
electric shock
IS0 9687: 1993, Dental equipment - Graphical sym-
bols.
Dental operating lights are classified as follows:
IEC 598-l :I 986, Luminaires - Part I: General re-
a) Class I equipment
quirements and tests.
Equipment in which protection against electric
shock does not rely on basic insulation only, but
I EC 601-I :I 988, Medical electrical equipment - Part
which includes an additional safety precaution in
7: General requirements for safety.
such a way that means are provided for the con-
nection of accessible conductive parts to the pro-
CIE 15.2:1986, Calorimetry.
tective (earth) conductor in the fixed wiring of the
Cl E 69: 1987, Methods of characterizing i/luminance installation in such a way that accessible
meters and luminance meters; Performance, charac- conductive parts cannot become live in the event
teris tics and specifications. of a failure of the basic insulation.
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
b) Class II equipment Testing shall be carried out in accordance with 7.2.
Equipment in which protection against electric If the equipment also passes all the tests described
shock does not rely on basic insulation only, but in in this International Standard, it shall be considered
which additional safety precautions such as double that these requirements are fulfilled.
insulation or reinforced insulation are provided,
In addition, it is recommended that edges and corners
there being no provision for protective earthing or
of components and parts accessible to the patient or
reliance upon installation conditions.
personnel should be finished in such a manner as to
avoid injury to the patient or personnel.
4.2 According to degree of protection
against electric shock
5.2 Optical
Dental operating lights are only of type B equipment.
5.2.1 Level of illuminance
Type B equipment
Class I or II equipment, or equipment with an internal The level of illuminance shall be adjustable. The ad-
justment should preferably be continuous but, if in
electrical power source providing an adequate degree
steps, it shall be made with at least three levels of
of protection against electric shock particularly re-
illuminance (two approximately equal steps). The ad-
garding:
justment of illumination shall include a range from
8 000 lx to 15 000 lx.
- allowable leakage currents;
Testing shall be carried out in accordance with 7.2 and
- reliability of the protective earth connection (if
7.3.2.
present).
Type B equipment is, for example, suitable for inten-
5.2.2 Illumination pattern
tional external and internal application to the patient,
excluding direct cardiac application.
The area of illuminance shall lie within a circle of
50 mm diameter with no illuminance less than 75 %
4.3 According to mode of operation of the maximum. If the illuminance pattern is larger
than the 50 mm diameter circular area, the 50 % of
Dental operating lights are a type of equipment with
maximum illuminance isolux should be plotted (see
continuous operation.
figure 1).
Testing shall be carried out in accordance with 7.3.2.
4.4 Marking or identification
The classification shall be marked or identified in ac- 5.2.3 Illumination uniformity
cordance with 8.2.
The illumination shall decrease in intensity progress-
ively and smoothly (with reversal of slope not ex-
5 Requirements and recommendations
ceeding 10 % of the centre illumination) toward the
pattern edge, within the limits given in 5.2.2.
5.1 General
with 7.3.2.
Testing shall be carried out in accordance
Dental operating lights shall be designed, constructed
and manufactured so that, when properly transported,
5.2.4 Illumination in patient’s eyes
stored, installed, used and maintained according to
the manufacturer’s instructions, they cause no danger
The level of illumination 60 mm above a line parallel
which could reasonably be foreseen to the patient, to
to a horizontal line through the area of maximum
the personnel or to the surroundings in normal use
illuminance shall be not greater than 1 200 lx (see
and in single-fault condition.
figure 1).
The dental operating light shall have the strength and
Testing shall be carried out in accordance with 7.3.2.
rigidity necessary to resist the stresses to which it
may be subjected in normal dental practice without
5.2.5 Light points in reflector
risk of introducing fire, electric shock or accident haz-
ard.
The reflector should be free of glare in the patient’s
Those dental operating lights which are intended to
eyes during normal operation.
be permanently fixed on the ceiling, the wall or the
Testing shall be carried out in accordance with 7.2.
floor shall have provision for this (see 5.3.4.3).
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
Dimensions in millimetres
L3
---M---A---
--A-B----- --
k
A Area of illuminance > 0,75 L,,,
B Area with illumination 2 0,5 L,,, and G 0,75 L,,,
L Point of maximum illuminance, somewhere within the area of illuminance A
max
Illuminance within the area of illuminance L, a 0,75 L,,,
Ll
Line of pattern with L = 0,5 Lmax
L,
Illumination at a distance of 60 mm 5 G 1 200 lx
b3
Figure 1 - Illumination pattern
3
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
0,480
0,460 f \
I I I I I I
0,180 0,190 0,200 0,210 0,220 0,230 0,240
u
2
Figure - Part of CIE 1976 CIELUV uniform chromaticity scale diagram
5.2.6 Chromatic aberration Testing shall be carried out in accordance with 7.3.5.
No colour separation (chromatic aberration) of the light
5.2.9 Shadow
incident upon the screen shall be visible inside the
50 % of maximum illuminance isolux line.
The hard shadow of a 20 mm object at a distance of
Testing shall be carried out in accordance with 7.3.3.
50 mm shall have no dimension greater than 12 mm.
Testing shall be carried out in accordance with 7.3.6.
5.2.7 Correlated colour temperature
The light emitted by the dental operating light shall
5.3 Mechanical
have a correlated colour temperature between
3 600 K and 6 500 K at 15 000 lx at the origin of the
coordinates of the target.
5.3.1 Moving parts
The trichromatic coordinates of the four extreme
Moving parts that may constitute a hazard under
points are given in figure2
normal working conditions shall be protected or
guarded to minimize the risk of injury to the patient
The manufacturer shall supply the spectrum emission
and personnel.
curve of the dental operating light at 15 000 lx to-
gether with the black body response curve at the
The distance between power-activated moving parts
corresponding correlated colour temperature, so that
which are accessible to patient’s and personnel’s
they may be compared.
hands and fingers shall be less than 10 mm when
fully opened or a minimum of 20 mm when fully
Testing shall be carried out in accordance with 7.3.4.
closed.
5.2.8 Radiant heat in pattern
All electrical cables shall be adequately protected
against wear, fracture and damage due to rubbing or
The temperature rise shall be at as low a temperature
strain incurred during normal operation of the dental
as possible and not greater than 15 K at any point in
operating light.
the illumination pattern with the dental light operating
at its maximum illuminance level. IEC 601-I :I 988, clause 22 applies.
4
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SIST EN ISO 9680:2000
IS0 9680:1993(E)
Immediately after the test the dental operating light
Testing shall be carried out in accordance with 7.3.7.
shall:
5.3.2 Operating controls
- retain its physical integrity;
Controls should be located in a position, and be of
- withstand the dielectric strength test specified in
such design, as to preclude the likelihood of being
IEC 601-I :I 988, clause 20, when inspection shall
accidentally activated.
show that the water which may have entered the
equipment can have no harmful effect; in particu-
Operating symbols as specified in IS0 9687 shall be
lar, there shall be no trace of water on insulation
used where they exist.
for which creepage distances are specified in
I EC 601-I : 1988, clause 57.10.
Testing shall be carried out in accordance with 7.2.
Testing shall be carried out in accordance with
7.3.11.
5.3.3 Rotary movement
The light should be designed to avoid the risk of
5.3.6 Expelled parts
damage to electrical conductors during rotary move-
ment.
The Iuminaire shall be designed to provide protection
against the effects of shattering lamps. No part of a
Testing shall be carried out in accordance with 7.2.
shattered lamp should be expelled.
Testing shall be carried out in accordance with
5.3.4 Handling and mechanical adjustment
7.3.12.
5.3.4.1 Stability after positioning
5.3.7 Suspended masses
The dental operating light sha I be free from apparent
IEC 601-I :I 988, clause 28 applies.
drift when positioned.
Testing shall be carried out in accordance with 7.3.8.
5.4 Disinfection and cleaning
5.3.4.2 Operating forces All exterior touchable parts of the dental operating
light shall be capable of undergoing disinfection with-
If the dental operating light is adjustable by the per- out deterioration of the light’s surface or markings
sonnel from one position to another, it should allow when using chemically relevant agents recommended
quick and easy movement and be stable in its new by the manufacturer.
position. The force required at the handle to reposition
All exterior touchable parts of the dental operating
the dental operating light shall not exceed 30 N. Minor
light shall be capable of undergoing cleaning without
adjustments to the position of the light source as-
deterioration of the light’s surface or markings by us-
sembly shall not require a force greater than 7 N.
ing agents recommended by the manufacturer.
Testing shall be carried out in accordance with 7.3.9.
All safety requirements shall be maintained after the
disinfection and cleaning test.
5.3.4.3 General stability
Testing shall be carried out in accordance with
If the dental operating light is fixed to a pillar or post, 7.3.13.
it shall not be possible to tip it about the base edge.
If the dental operating light is fixed to the ceiling or
5.5 Electrical
wall, the fixing shall not be damaged or disrupted.
Testing shall be carried out in accordance with
5.5.1 Power input
7.3.10.
IEC 601-I :I 988, clause 7 applies.
5.3.4.4 Mechanical strength
5.5.2 Single fault conditions
IEC 601-I :I 988, clause 21 applies.
IEC 601-I :I 988, clause 3.6 applies.
5.3.5 VVater penetration
5.5.3 Protection against electric shock hazards
The dental operating light shall not present a hazard
IEC 601-I : 1988, clause 13 applies.
when tested in accordance with 7.3.11.
5
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SIST EN ISO 9680:2000
IsO 9680:1993(E)
5.5.10 Dielectric strength
5.5.4 Requirements related to classification
The dielectric strength shall be sufficient to withstand
equipment
5.5.4.1 Class I
the test voltages as specified in IEC 601-I :I 988,
clause 20, except 20.2.
clause 14.1 applies.
IEC 601-1:1988,
Testing shall be carried out in accordance with
7.3.15.
equipment
5.5.4.2 Class II
5.5.11 Excessive temperatures
IEC 601-I :I 988, clause 14.2 applies.
IEC 601-I :I 988, clause 42 applies (in particular clause
5.5.4.3 Type B
42 table Xa, last line).
IEC 601-I :I 988, clause 14.6 applies, limited to type
5.5.12 Interruption of power supply
B .
IEC 601-I : 1988, clauses 49.1 to 49.3 apply.
5.5.5 Limitation of voltage and/or energy
5.5.13 Protection against incorrect ou
...
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