SIST EN ISO 9680:2007
Dentistry - Operating lights (ISO 9680:2007)
Dentistry - Operating lights (ISO 9680:2007)
This International Standard specifies requirements and test me thods for dental operating lights intended for illuminating th e oral cavity of patients. It also contains specifications on manufacturer's instructions, marking and packaging. Excluded a re auxiliary light sources, e. g. from dental handpieces and d ental headlamps. Excluded are also dental luminaires, which ar e specifically designed for use in a dental surgery.
Zahnheilkunde - Zahnärztliche Behandlungsleuchte (ISO 9680:2007)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Behandlungsleuchten fest, die zur Ausleuchtung der Mundhöhle von Patienten vorgesehen sind. Sie enthält auch Festlegungen für die Gebrauchsanweisung des Herstellers, Kennzeichnung und Verpackung.
Diese Internationale Norm gilt für Behandlungsleuchten, die an der Decke, an den Wänden oder auf dem Boden dauerhaft befestigt werden.
Ausgenommen sind zusätzliche Lichtquellen, z. B. von zahnärztlichen Handstücken und zahnärztlichen Stirnlampen.
Ausgenommen sind ferner Dentalleuchten, die speziell zum Einsatz in einer chirurgischen Praxis vorgesehen sind.
Art dentaire - Appareils d'éclairage (ISO 9680:2007)
L'ISO 9680:2007 spécifie les exigences et les méthodes d'essai pour les appareils d'éclairage utilisés dans les cabinets dentaires et destinés à éclairer la cavité buccale des patients. Elle contient également des spécifications relatives aux instructions du fabricant, au marquage et à l'emballage.
L'ISO 9680:2007 s'applique aux appareils d'éclairage qui sont destinés à être fixés en permanence au plafond, au mur ou au sol.
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9680:2007
01-september-2007
1DGRPHãþD
SIST EN ISO 9680:2000
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2007)
Dentistry - Operating lights (ISO 9680:2007)
Zahnheilkunde - Zahnärztliche Behandlungsleuchte (ISO 9680:2007)
Art dentaire - Appareils d'éclairage (ISO 9680:2007)
Ta slovenski standard je istoveten z: EN ISO 9680:2007
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 9680:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 9680
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2007
ICS 11.060.20 Supersedes EN ISO 9680:1996
English Version
Dentistry - Operating lights (ISO 9680:2007)
Art dentaire - Appareils d'éclairage (ISO 9680:2007) Zahnheilkunde - Behandlungsleuchten (ISO 9680:2007)
This European Standard was approved by CEN on 9 June 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9680:2007: E
worldwide for CEN national Members.
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EN ISO 9680:2007 (E)
Foreword
This document (EN ISO 9680:2007) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 "Dentistry", the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by December 2007, and conflicting national
standards shall be withdrawn at the latest by December 2007.
This document supersedes EN ISO 9680:1996.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 9680:2007 has been approved by CEN as EN ISO 9680:2007 without any
modifications.
2
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INTERNATIONAL ISO
STANDARD 9680
Second edition
2007-06-15
Dentistry — Operating lights
Art dentaire — Appareils d'éclairage
Reference number
ISO 9680:2007(E)
©
ISO 2007
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ISO 9680:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 9680:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Classification. 2
4.1 According to type of protection against electric shock . 2
4.2 According to mode of operation . 3
5 Requirements and recommendations .3
5.1 General requirements. 3
5.2 Optical requirements. 3
5.3 Mechanical requirements. 6
5.4 Cleaning and disinfection . 7
5.5 Electrical requirements . 7
6 Sampling. 8
7 Testing . 9
7.1 General. 9
7.2 Test conditions . 9
7.3 Visual inspection . 11
7.4 Optical tests . 11
7.5 Mechanical tests . 14
7.6 Cleaning and disinfection . 14
7.7 Electrical tests. 14
8 Manufacturer's instructions. 15
8.1 Documents . 15
8.2 General. 15
8.3 Instructions for use . 15
8.4 Technical description. 15
8.5 Check . 15
9 Packaging . 15
10 Marking . 16
10.1 Marking on the outside of mains-operated operating lights. 16
10.2 Marking on the inside of operating lights . 16
10.3 Marking of operating controls . 16
10.4 Graphical symbols. 16
10.5 Colours of insulation conductors . 16
10.6 Indicator lights and push-buttons. 16
Annex A (informative) Transformation formulae . 17
Bibliography . 18
© ISO 2007 – All rights reserved iii
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ISO 9680:2007(E)
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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 9680 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 9680:1993) and ISO 9680:1993/Cor.1:1995
which have been technically revised via the following changes:
a) the illumination pattern has been changed from a round area, A, with a diameter of 50 mm into an ellipse
with a horizontal axis of 50 mm and a vertical axis of 25 mm;
b) the level of illuminance shall be adjustable with a minimum level u 8 000 lx and a maximum level
W 20 000 lx;
c) a requirement for the general colour rendering index (Ra > 85) for diagnostic purposes is added;
d) a requirement for UV irradiance has been added;
2 2
e) the radiant heat in pattern shall be measured as the irradiance, E, in W/m (E u 350 W/m ).
iv © ISO 2007 – All rights reserved
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ISO 9680:2007(E)
Introduction
The aim of this International Standard 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 perception of colour or causing excessive fatigue.
In this International Standard, the safety of an operating light is assessed 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 an operating light should
not render the equipment unsafe.
In preparing this International Standard account has been taken of IEC 60598-1.
This International Standard refers to IEC 60601-1, the basic standard on safety of medical electrical
equipment, wherever relevant, by stating the respective clause numbers of IEC 60601-1.
This International Standard takes priority over IEC 60601-1 as specified in its individual clauses.
Only the specifications laid down in this International Standard are applicable.
© ISO 2007 – All rights reserved v
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INTERNATIONAL STANDARD ISO 9680:2007(E)
Dentistry — Operating lights
1 Scope
This International Standard specifies requirements and test methods for operating lights used in the dental
office and intended for illuminating the oral cavity of patients. It also contains specifications on manufacturers'
instructions, marking and packaging.
This International Standard applies to operating lights that are intended to be permanently fixed to the ceiling,
or to the wall or to the floor.
Excluded are auxiliary light sources, e.g. from dental handpieces and dental headlamps.
Also excluded are dental luminaires, which are specifically designed for use in a dental surgery.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 554, Standard atmospheres for conditioning and/or testing — Specifications
1)
ISO 1942 , Dentistry — Vocabulary
ISO 9687, Dental equipment — Graphical symbols
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
IEC 60050-845, International Electrotechnical Vocabulary. Lighting
IEC 60598-1:2006, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
CIE Publication 13.3, Method of measuring and specifying colour rendering properties of light sources
CIE Publication 15:2004, Colorimetry
CIE Publication 69, Methods of characterizing illuminance meters and luminance meters: Performance,
characteristics and specifications
1) To be published. (Replaces ISO 1942, parts 1 to 5)
© ISO 2007 – All rights reserved 1
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ISO 9680:2007(E)
ICNIRP Guidelines, Guidelines on Limits of Exposure to Ultraviolet Radiation of Wavelengths between 180 nm
and 400 nm (Incoherent Optical Radiation) of the International Commission on Non-Ionizing Radiation
Protection, Health Physics, 87, Number 2, pp. 171-186, August 2004
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60050-845, IEC 60598-1,
IEC 60601-1, ISO 1942 and the following apply.
3.1
luminaire
apparatus which distributes, filters or transforms the light transmitted from one or more lamps and which
includes all the parts necessary for supporting, fixing and protecting the lamps, but not the lamps themselves,
and where necessary circuit auxiliaries together with the means for connecting them to the supply
[IEC 60598-1:2006, 1.2.1]
3.2
lamp
light source
3.3
dental luminaire
luminaire specially designed and/or presented for use in the dental surgery
3.4
operating light
item of dental equipment specially designed for use by a dentist for illuminating the oral cavity, consisting of a
luminaire (3.1) and one or more lamps
3.5
illuminance
luminous flux incident on a surface per unit of area, usually measured in lux
4 Classification
4.1 According to type of protection against electric shock
Operating lights are classified as follows:
a) Class I equipment (see IEC 60601-1:2005, 3.13)
Equipment in which protection against electric shock does not rely on basic insulation only, but which includes
an additional safety precaution in such a way that means are provided for the connection of accessible
conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that
accessible conductive parts cannot become live in the event of a failure of the basic insulation.
b) Class II equipment (see IEC 60601-1:2005, 3.14)
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.
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ISO 9680:2007(E)
4.2 According to mode of operation
See IEC 60601-1:2005, 6.6.
Operating lights shall be suitable for continuous operation.
5 Requirements and recommendations
5.1 General requirements
Operating lights shall be designed, constructed and manufactured so that, when properly transported, stored,
installed, used and maintained according to the manufacturer's instructions, they cause no danger which
could reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in
single-fault condition.
If the equipment passes all the tests described in this International Standard, it shall be considered that these
requirements are fulfilled.
In addition, it is recommended that edges and corners of components and parts accessible to the patient or
personnel shall be finished in such a manner as to avoid injury to the patient or personnel.
Operating lights should be capable of being adjusted so as to minimize the variation in illumination of the oral
cavity in all operating positions, maintaining the 1 200 lx line parallel with the bi-pupillar line in accordance with
5.2.3.1.
Test in accordance with 7.3.
5.2 Optical requirements
5.2.1 Level of illuminance
The level of illuminance shall be adjustable with a minimum level u 8 000 lx and a maximum level W 20 000 lx.
The adjustment between these levels should be continuous.
Test in accordance with 7.3 and 7.4.2.
5.2.2 Illumination pattern
5.2.2.1 Illumination areas
The illumination areas A and B are shown in Figure 1.
The inner area of illumination, area A, is defined by an ellipse with a horizontal axis of 50 mm and a vertical
axis of 25 mm.
The outer area of illumination, area B, is defined as the area between the 50 % of maximum illuminance isolux
line and the inner area A.
The 50 % of maximum illuminance isolux line shall be plotted in order to indicate area B (see Figure 1).
5.2.2.2 Illuminance
The point of the maximum illuminance shall lie within the area A. Throughout area A the illuminance shall not
be less than 75 % of the maximum illuminance (see Figure 1).
Test in accordance with 7.4.2.
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ISO 9680:2007(E)
Dimensions in millimetres
Key
A inner area of illumination
B outer area of illumination
L point of maximum illuminance
max
L illuminance within the area A
1
L line of pattern with L = 0,5 L
2 max
L illuminance at a distance of 60 mm, L < 1 200 lx
3 3
Figure 1 — Illumination pattern
5.2.2.3 Illumination uniformity
The illumination shall decrease in intensity progressively and smoothly toward the pattern edge, within the
limits given in 5.2.2.2.
Test in accordance with 7.4.3.
5.2.3 Illuminance in the patient's eyes
5.2.3.1 Level of illuminance
The level of illuminance at a distance of 60 mm above a line parallel to a horizontal line through the area of
maximum illuminance shall be no greater than 1 200 lx (see Figure 1) in all operating positions around the oral
cavity.
Test in accordance with 7.4.2.
5.2.3.2 Glare or reflections from the reflector
No glare or reflections from the reflector should fall on to the patient's eyes during normal operation.
Test in accordance with 7.3.
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ISO 9680:2007(E)
5.2.4 Chromatic aberration
No chromatic aberration (colour separation) of the light incident upon the measuring screen shall be visible in
area B and area A.
Test in accordance with 7.4.4.
5.2.5 Correlated colour temperature
The trichromatic co-ordinates of the four extreme points are given in Table 1. The chromaticity co-ordinates
(x, y) of the light emitted by the operating lights shall be within the field defined by the coordinates in Table 1.
Test in accordance with 7.4.5.
Table 1 — Co-ordinates of colour space
Chromaticity co-ordinates LUV colour space of CIE 15.2
Corner point
' '
x y u v
1 0,310 0,369 0,182 0,488
2 0,316 0,322 0,203 0,465
3 0,414 0,428 0,227 0,527
4 0,396 0,377 0,235 0,504
NOTE Further information on the transformation formulae is given in Annex A.
5.2.6 Radiant heat in pattern
2
The radiant heat in pattern shall be measured as the irradiance, E, in W/m . The irradiance shall be
2
u 350 W/m at the maximum illuminance level.
Test in accordance with 7.4.6.
5.2.7 Shadow
The hard shadow of a disc with 20 mm diameter at a distance of 50 mm shall have no dimension greater than
12 mm.
Test in accordance with 7.4.7.
5.2.8 General colour rendering index (Ra)
Operating lights used for diagnostic purposes shall have a general colour rendering index Ra > 85.
Test in accordance with 7.4.8.
5.2.9 UV irradiance
The effective UV irradiance at the maximum level of the operating light in the spectral region of 180 nm to
2
400 nm shall not exceed 0,008 W/m , spectrally weighted using the spectral weighting factors contained in
Table 1 of the ICNIRP guidelines 87 (2).
Test in accordance with 7.4.9.
2
NOTE This requirement is equivalent to a maximum effective radiant exposure of 30 J/m , spectrally weighted
according to the referenced document, in one hour under the specified test conditions.
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ISO 9680:2007(E)
5.3 Mechanical requirements
5.3.1 Moving parts
Moving parts that may constitute a hazard under normal working conditions shall be protected or guarded in
order to minimize the risk of injury to the patient and personnel.
The distance between power-activated moving parts that are accessible to patients' and personnel's hands
and fingers shall be less than 10 mm when fully opened or a minimum of 20 mm when fully closed.
All electric cables shall be adequately protected against wear, fracture and damage due to rubbing or strain
incurred during normal operation of the operating light.
IEC 60601-1:2005, 9.2 applies.
Test in accordance with 7.5.1.
5.3.2 Operating controls
Operating controls shall be located in a position, and be of such design, as to preclude the likelihood of being
accidentally activated.
Symbols for operating controls shall be used as specified in ISO 9687 where they exist.
Test in accordance with 7.3.
5.3.3 Rotary movement
Operating lights shall be designed to avoid the risk of damage to electrical conductors during rotary movement.
Test in accordance with 7.3.
5.3.4 Handling and mechanical adjustment
5.3.4.1 General stability
If the operating light is fixed to a pillar or post, it shall not be possible to tip it. If the operating light is fixed to
the ceiling or wall, the fixing shall not be damaged or disrupted.
Test in accordance with 7.5.4.
5.3.4.2 Stability after positioning
Operating lights shall be free from apparent drift when positioned.
Test in accordance with 7.5.2.
5.3.4.3 Operating forces
If the operating light is adjustable by the personnel, from one position to another, it should allow quick and
easy movement and be stable in its new position. The force required at the handle used to reposition the
operating light shall not exceed 30 N. Minor adjustments to the position of the light source assembly shall not
require a force greater than 7 N.
Test in accordance with 7.5.3.
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ISO 9680:2007(E)
5.3.4.4 Mechanical strength
IEC 60601-1:2005, 9.1 applies.
5.3.5 Expelled parts
The luminaire of an operating light shall be designed to provide protection against the effects of shattering
lamps. No part of a shattered lamp shall be expelled.
Test in accordance with 7.5.5.
5.3.6 Suspended masses
IEC 60601-1:2005, 9.8 applies.
5.4 Cleaning and disinfection
All exterior touchable parts of the operating light shall be capable of undergoing cleaning without deterioration
of the light's surface or markings by using agents recommended by the manufacturer.
All exterior touchable parts of the operating light shall be capable of undergoing disinfection without
deterioration of the light's surface or markings when using chemically relevant agents recommended by the
manufacturer.
All safety requirements shall be maintained after the cleaning and disinfection test.
Test in accordance with 7.6.
5.5 Electrical requirements
5.5.1 Power input
IEC 60601-1:2005, 4.11 applies.
5.5.2 Single fault conditions
IEC 60601-1:2005, 4.7 applies.
5.5.3 Protection against electric shock hazards
IEC 60601-1:2005, 8.1 applies.
5.5.4 Requirements related to classification
5.5.4.1 Class I equipment
IEC 60601-1:2005, 8.3 applies.
5.5.4.2 Class II equipment
IEC 60601-1:2005, 8.3 applies.
5.5.5 Limitation of voltage and/or energy
IEC 60601-1:2005, 8.4 applies.
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ISO 9680:2007(E)
5.5.6 Enclosures and protective covers
IEC 60601-1:2005, 5.9 applies.
5.5.7 Separation
IEC 60601-1:2005, 8.5 applies.
5.5.8 Protective earthing, functional earthing and potential equalization
IEC 60601-1:2005, 8.6 applies.
5.5.9 Leakage currents
IEC 60601-1:2005, 8.7 applies.
Testing shall be carried out in accordance with 7.7.1.
5.5.10 Dielectric strength
The dielectric strength shall be sufficient to withstand the test voltages as specified in IEC 60601-1:2005, 8.8.
Testing shall be carried out in accordance with 7.7.2.
5.5.11 Excessive temperature
IEC 60601-1:2005, 11.1 applies.
5.5.12 Interruption of power supply
IEC 60601-1:2005, 15.4.2.1 a), 11.8 and 9.2.5 apply.
5.5.13 Protection against incorrect output
IEC 60601-1:2005, 12.4.1 and 12.4.4 apply.
5.5.14 Components and general assembly
IEC 60601-1:2005, 15.4 applies.
5.5.15 Mains parts, components and layout
IEC 60601-1:2005, 8.11 applies.
5.5.16 Protective earthing: terminals and connections
IEC 60601-1:2005, 8.6 applies.
5.5.17 Construction and layout
IEC 60601-1:2005, 3.62, 8.8.4, 8.10.5, 8.10.6, 8.10.7, 15.4.3.5 and 15.4.8 apply.
6 Sampling
All type tests shall be made on one representative sample of the operating light.
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ISO 9680:2007(E)
7 Testing
7.1 General
All tests described in this International Standard are type tests.
7.2 Test conditions
7.2.1 General provisions for testing
The test sequence shall be in accordance with IEC 60601-1:2005, Annex B. Testing shall be carried out by
independent test laboratories.
The operating light intended to be tested shall be new.
Since some of the tests described are destructive tests, the operating light tested shall not be used afterwards.
The rating of components shall be inspected to c
...
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