EN ISO 9680:2021

SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST EN ISO 9680:2015
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2021)
Dentistry - Operating lights (ISO 9680:2021)
Zahnheilkunde - Behandlungsleuchten (ISO 9680:2021)
Médecine bucco-dentaire - Lampes opératoires (ISO 9680:2021)
Ta slovenski standard je istoveten z: EN ISO 9680:2021
ICS:
11.060.20 Zobotehnična oprema Dental equipment
91.160.10 Notranja razsvetljava Interior lighting
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 9680
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 9680:2014
English Version
Dentistry - Operating lights (ISO 9680:2021)
Médecine bucco-dentaire - Lampes opératoires (ISO Zahnheilkunde - Behandlungsleuchten (ISO
9680:2021) 9680:2021)
This European Standard was approved by CEN on 15 October 2021.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9680:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 9680:2021) 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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9680:2014.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 9680:2021 has been approved by CEN as EN ISO 9680:2021 without any modification.

INTERNATIONAL ISO
STANDARD 9680
Fourth edition
2021-11
Dentistry — Operating lights
Médecine bucco-dentaire — Luminaires opératoires
Reference number
ISO 9680:2021(E)
ISO 9680:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 9680:2021(E)
Contents Page
Foreword .v
Introduction . vi
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 . 2
5 Requirements and recommendations . 2
5.1 General requirements . 2
5.2 Optical requirements . 3
5.2.1 Adjustable level of illuminance . 3
5.2.2 Illumination pattern. 3
5.2.3 Illuminance in patient's eyes . 4
5.2.4 Chromatic uniformity . 5
5.2.5 Correlated colour temperature . 5
5.2.6 Shadow . 6
5.2.7 Colour fidelity. 6
5.2.8 Actinic UV hazard exposure for the skin and eye . 6
5.2.9 Near-UV hazard exposure for the eye . 6
5.2.10 Retinal blue light hazard exposure . 7
5.2.11 Single fault condition for photobiological safety . 7
5.2.12 Heat due to optical radiation . 7
5.2.13 Compatibility with light-activated restorative materials. 7
5.3 Mechanical requirements . 7
5.3.1 Moving parts . 7
5.3.2 Operating controls . 7
5.3.3 Rotary movement . 8
5.3.4 Handling and mechanical adjustment . 8
5.3.5 Expelled parts . 8
5.4 Reprocessing . 8
5.5 Electrical requirements. 8
5.6 Usability . 8
6 Sampling . 9
7 Testing. 9
7.1 General . 9
7.2 Visual inspection . 9
7.3 Optical tests . 9
7.3.1 Test set-up . 9
7.3.2 Level of illuminance and illuminance pattern . 9
7.3.3 Illuminance uniformity . 10
7.3.4 Illuminance in the patient’s eyes . 10
7.3.5 Chromatic uniformity . 10
7.3.6 Correlated colour temperature . 11
7.3.7 Shadow . 11
7.3.8 Colour fidelity.12
7.3.9 Actinic UV hazard exposure for the skin and eye .12
7.3.10 Near-UV hazard exposure for the eye .12
7.3.11 Retinal blue light hazard exposure . 13
7.3.12 Heat due to optical radiation . 14
7.3.13 Compatibility with light-activated restorative materials. 14
7.4 Mechanical tests . 15
iii
ISO 9680:2021(E)
7.4.1 Moving parts . 15
7.4.2 Stability after positioning . 15
7.4.3 Operating force . 15
8 Manufacturer's instructions .15
8.1 Documents. 15
8.2 General . 15
8.3 Instructions for use . 15
8.4 Technical description. 16
8.5 Check . 16
9 Packaging.16
10 Marking . .16
10.1 Marking on the outside of mains-operated operating lights . 16
10.2 Marking on the inside of operating lights . 17
10.3 Graphical symbols . 17
10.4 Colours of the insulation of conductors. 17
10.5 Indicator lights and push-buttons . 17
Annex A (informative) Transformation formulae .18
Annex B (normative) Normalized absorbance of camphorquinone.19
Bibliography .21
iv
ISO 9680:2021(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6,
Dental equipment, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 9680:2014), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— normative references have been updated;
— requirements and test methods for the illumination pattern, illuminance in patient’s eyes, colour
fidelity and photobiological hazards have been updated.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 9680:2021(E)
Introduction
This document provides 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 or photobiological injury.
In this document, 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 nor affect its qualities adversely.
IEC 60598-1 has been taken into account during the preparation of this document.
This document 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 document takes priority over IEC 60601-1 as specified in the individual clauses of this document.
Only the specifications laid down in this document are applicable.
vi
INTERNATIONAL STANDARD ISO 9680:2021(E)
Dentistry — Operating lights
1 Scope
This document 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 the
instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental
headlamps and also operating lights which are specifically designed for use in oral surgery.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1942, Dentistry — Vocabulary
ISO 4073, Dentistry — Information system on the location of dental equipment in the working area of the
oral health care provider
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 11664-1, Colorimetry — Part 1: CIE standard colorimetric observers
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO/CIE 19476, Characterization of the performance of illuminance meters and luminance meters
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
IEC 60598-1, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 62471:2006, Photobiological safety of lamps and lamp systems
IEC/TR 62471-2:2009, Photobiological safety of lamps and lamp systems — Part 2: Guidance on
manufacturing requirements relating to non-laser optical radiation safety
ISO 9680:2021(E)
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety
and essential performance of dental equipment
CIE 224, Colour Fidelity Index for accurate scientific use
CIE S 017, ILV: International Lighting Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60598-1,
IEC 60601-1, CIE S 017 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
operating light
device designed for use by an operator for illuminating the oral cavity, which either distributes, filters
or transforms the light, or does any combination of these, transmitted from one or more light sources
and which includes all parts necessary for supporting, fixing and protecting the light sources, and
circuit auxiliaries together with the means of connecting them to the supply
3.2
light-activated restorative material
dental material intended for oral use that incorporates a monomer system, the polymerization of
which is activated by light
4 Classification
4.1 According to type of protection against electric shock
Operating lights are classified in accordance with IEC 60601-1 as follows:
a) Class I equipment; or
b) Class II equipment.
4.2 According to mode of operation
Operating lights are classified in accordance with IEC 60601-1 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 instructions, they cause no danger which can
reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in
single-fault condition.
Operating lights shall be capable of being adjusted so as to permit illumination of the oral cavity in all
patient operating positions.
If the equipment passes all the tests described in this document, it shall be considered that these
requirements are fulfilled.
ISO 9680:2021(E)
5.2 Optical requirements
5.2.1 Adjustable level of illuminance
The level of illuminance shall be adjustable between a minimum level and maximum level specified by
the manufacturer. The maximum level of illuminance shall be at least 15 000 lx at a distance of 700 mm
from the operating light.
The adjustment of illuminance may be either continuous or in discrete levels.
Test in accordance with 7.2 and 7.3.2.
The requirements of 5.2.1 do not apply to any operating mode(s) intended only for use while handling
light-activated restorative materials.
5.2.2 Illumination pattern
5.2.2.1 Illumination areas and illuminance levels
The illumination pattern shall be measured to determine the maximum illuminance, E , and the
v,max
following iso-illuminance lines in accordance with 7.3.2: 0,90 × E , 0,75 × E , 0,50 × E ,
v,max v,max v,max
0,10 × E and 1 200 lx.
v,max
The inner area of illumination, area A, is defined as the area bounded by the iso-illuminance line
corresponding to 75 % of the maximum illuminance. The outer border of area A shall be on or outside of
an ellipse with a horizontal axis of 50 mm and a vertical axis of 25 mm, in which the horizontal axis and
vertical axis of the ellipse are aligned with the major axis and minor axis of the illumination pattern,
respectively (see Figure 1). The illuminance shall not be less than 75 % of E throughout the ellipse.
v,max
Test in accordance with 7.3.2.
The outer area of illumination, area B, is defined as the area bounded by the iso-illuminance line
corresponding to 50 % of the maximum illuminance. The outer border of area B shall be on or outside
of an ellipse with a horizontal axis of 80 mm and a vertical axis of 40 mm and with the same axes as the
smaller ellipse associated with area A (see Figure 2). Test in accordance with 7.3.2.
Dimensions in millimetres
Key
A inner area of illumination
Figure 1 — Example of illumination pattern which satisfies the requirement for area A
ISO 9680:2021(E)
Dimensions in millimetres
Key
B outer area of illumination
Figure 2 — Example of illumination pattern which satisfies the requirement for area B
5.2.2.2 Illuminance uniformity
The illuminance shall decrease in intensity progressively and smoothly toward the pattern edge.
Test in accordance with 7.3.3.
5.2.3 Illuminance in patient's eyes
An area C is defined as the area bounded by the iso-illuminance line corresponding to 90 % of the
maximum illuminance. The level of illuminance at all points on or above a horizontal line 60 mm above
the uppermost point of area C shall not be greater than 1 200 lx (see Figure 3).
The operating light should preferably be capable of rotating about the X, Y and Z axes in order to
allow the operator maximum flexibility in positioning the operating light while preventing excessive
illuminance in the patient’s eyes.
Test in accordance with 7.3.4.
ISO 9680:2021(E)
Dimensions in millimetres
Key
C area bounded by the iso-illuminance line corresponding to 90 % of maximum illuminance
Figure 3 — Example of illumination pattern which satisfies the requirement for limiting
illuminance in the patient’s eyes
5.2.4 Chromatic uniformity
No perceptible chromatic variation (colour separation) of the light incident upon the measuring screen
shall be visible in area A and area B.
Test in accordance with 7.3.5.
5.2.5 Correlated colour temperature
Over the full range of illuminance levels of the operating light, the CIE (x,y) chromaticity coordinates,
as specified in ISO/CIE 11664-1, within areas A and B of the illuminance pattern shall be within the
quadrilateral area bounded by the coordinates in Table 1. The CIE (u’,v’) chromaticity coordinates, as
specified in ISO/CIE 11664-5, of the four corner points are also given in Table 1.
NOTE The colour space bounded by the coordinates in Table 1 corresponds to correlated colour temperatures
between 3 600 K and 6 400 K.
Preferably, when the operating light is adjusted to the maximum illuminance level, the correlated colour
temperature should be between 4 500 K and 6 400 K.
Test in accordance with 7.3.6.
ISO 9680:2021(E)
The requirements of 5.2.5 do not apply to any operating modes intended only for use while handling
light-activated restorative materials.
Table 1 — Coordinates of colour space
CIE 1931 chromaticity coordinates CIE 1976 chromaticity coordinates
Corner point
x y u' v'
1 0,311 0,360 0,186 0,484
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 formulas between (x,y) and (u',v') coordinates is given in Annex A.
5.2.6 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 7.3.7.
5.2.7 Colour fidelity
For general illumination of the oral cavity, the operating light shall have a general colour fidelity index,
R , of at least 85.
f
NOTE The importance of accurately assessing colour in dental diagnosis and treatment while using an
operating light supports specifying R as the measure for colour fidelity in this document even though CIE 224
f
indicates that R is not intended as a universal replacement for the general colour rendering index, R , at this time.
f a
The decision to specify R in this document was made in consultation with CIE.
f
Test in accordance with 7.3.8.
The requirements of 5.2.7 do not apply to any operating modes intended only for use while handling
light-activated restorative materials.
5.2.8 Actinic UV hazard exposure for the skin and eye
The risk group classification of the operating light for actinic ultraviolet hazard (E ) shall be Risk
s
Group 1 or lower, as specified in IEC 62471:2006, 6.1, when tested under the conditions specified in 7.3.9.
Unless the operating light is classified as an exempt group for actinic ultraviolet hazard, the permissible
exposure duration, t , per IEC 62471:2006, 4.3.1 shall be calculated in accordance with 7.3.9.
max
Compliance with this requirement shall be verified either by documentation (e.g. test report by the light
source manufacturer) which verifies that all of the light sources used in the operating light do not emit
in the applicable wavelength range (200 nm to 400 nm), or by testing in accordance with 7.3.9.
5.2.9 Near-UV hazard exposure for the eye
The risk group classification of the operating light for near-UV hazard (E ) shall be Risk Group 1 or
UVA
lower, as specified in IEC 62471:2006, 6.1, when tested under the conditions specified in 7.3.10.
Unless the operating light is classified as exempt group for near-UV hazard, the permissible exposure
duration, t , per IEC 62471:2006, 4.3.2 shall be calculated in accordance with 7.3.10.
max
Compliance with this requirement shall be verified either by documentation (e.g. test report by the light
source manufacturer) which verifies that all of the light sources used in the operating light do not emit
in the applicable wavelength range (315 nm to 400 nm), or by testing in accordance with 7.3.10.
ISO 9680:2021(E)
5.2.10 Retinal blue light hazard exposure
The risk group classification for retinal blue light hazard (L ) per IEC 62471:2006, 6.1 shall be Risk
B
Group 1 or lower when tested under the conditions specified in 7.3.11.
Unless the operating light is classified as exempt group for retinal blue light hazard, the permissible
exposure duration, t , per IEC 62471:2006, 4.3.3 shall be calculated in accordance with 7.3.11.
max
Test in accordance with 7.3.11.
5.2.11 Single fault condition for photobiological safety
Analysis under single fault condition shall be applied to the requirements for actinic UV exposure for
skin and eye (see 5.2.8), near-UV exposure for the eye (see 5.2.9) and retinal blue light hazard exposure
(see 5.2.10). The operating light shall be considered single fault safe (IEC 60601-1:2005+AMD1: 2012+
AMD2: 2020, 4.7) if the risk group classification of the operating light does not exceed Risk Group 2
given in IEC 62471:2006, 6.1 under single fault condition.
NOTE A single fault condition, such as a short circuit or an open circuit of any component other than a
component with high-integrity characteristics or a software failure, can lead to a higher LED driving current,
increased light emission and a higher photobiological risk group classification.
5.2.12 Heat due to optical radiation
2 2
The irradiance over the wavelength range of 300 nm to 2 500 nm shall be ≤350 W/m (35 mW/cm ) at
the maximum illuminance level at a distance of 700 mm from the operating light.
Test in accordance with 7.3.12.
5.2.13 Compatibility with light-activated restorative materials
If the operating light is equipped with a setting intended for use while handling light-activated
restorative materials, the maximum illuminance in this setting shall be at least 6 500 lx and the
2 2
camphorquinone-weighted irradiance shall be less than 3,0 W/m (0,3 mW/cm ) when tested under the
conditions specified in 7.3.13. The camphorquinone-weighted irradiance is the integral of the product of
the operating light irradiance spectrum and the normalized absorption spectrum of camphorquinone
over the wavelength range of 400 nm to 515 nm (see 7.3.13).
NOTE The photo-initiator systems of commercial dental restorative materials are currently based on one
or more of the following: camphorquinone, 1-phenyl-1,2 propanedione (PPD), or acylphosphine oxides. Each of
these photo-initiators has a different absorbance spectrum. Since the absorbance spectrum of camphorquinone
extends to higher wavelengths than the other photo-initiators, the overlap with the emission spectrum of
operating lights is greatest with camphorquinone. Therefore, the camphorquinone absorbance spectrum is
expected to represent the worst-case challenge for evaluating possible effects of dental operating lights on light-
activated restorative materials.
Test in accordance with 7.3.13.
5.3 Mechanical requirements
5.3.1 Moving parts
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 9.2 applies.
Test in accordance with 7.4.1.
5.3.2 Operating controls
Operating controls shall be designed and located to minimize accidental activation. Graphical symbols
for operating controls and performance shall be in accordance with ISO 9687.
ISO 9680:2021(E)
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 15.1 applies.
5.3.3 Rotary movement
Operating lights shall be designed to avoid the risk of damage to electrical conductors during rotary
movement of all movable elements of the operating light.
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 9.2 applies.
5.3.4 Handling and mechanical adjustment
5.3.4.1 Stability after positioning
Operating lights shall be free from apparent drift when positioned.
Test in accordance with 7.4.2.
5.3.4.2 Operating forces
The force required at the handle 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 7.4.3.
5.3.4.3 Mechanical hazards
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 9.1 applies.
5.3.5 Expelled parts
The operating light shall be designed to provide protection against the effects of the shattering of its
light source if it is possible for the light source to shatter. This requirement is not relevant for LED light
sources.
The operating light shall so be designed that particles from a shattering light source cannot impair
safety. This shall be verified by appropriate risk analysis in accordance with ISO 14971.
5.4 Reprocessing
All exterior touchable parts of the operating light shall be suitable for reprocessing using the agents
and methods recommended by the manufacturer without deterioration of surfaces or labelling.
The manufacturer shall provide information on the reprocessing for the operating light in accordance
with ISO 17664-1 and ISO 17664-2, as applicable. Preferably, the handles should be sterilizable or
capable of accommodating reusable, sterilizable covers.
All safety requirements shall be maintained after the reprocessing test.
Testing of resistance against cleaning and disinfection shall be carried out in accordance with
ISO 21530.
5.5 Electrical requirements
Operating lights shall be suitable for continuous operation. IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020
and IEC 80601-2-60 apply.
5.6 Usability
Usability evaluation shall be carried out following the process described in IEC 62366-1.
ISO 9680:2021(E)
Testing shall be carried out in accordance with IEC 62366-1.
6 Sampling
All type tests shall be made on one representative sample of the operating light.
7 Testing
7.1 General
All tests described in this document are type tests.
Testing shall be performed at an ambient temperature of (23 ± 2) °C. The relative humidity shall be
between 30 % and 70 %.
All measurements of optical radiation shall be traceable to the international system of units (SI)
implemented through the requirements of ISO/IEC 17025.
7.2 Visual inspection
Visual inspection shall be performed at normal visual acuity without magnification.
7.3 Optical tests
7.3.1 Test set-up
Aim the light beam at a measuring screen, perpendicular to the optical axis, at a distance of 700 mm
measured from the external most forward part of the operating light from which light is emitted.
Adjust the controls for illumination during the tests at the setting of the maximum illuminance level
and operate until the irradiance and colour have stabilized, as determined by monitoring the running
average of the measurements, before collecting measurements for the tests specified in 7.3.2 through
7.3.13 unless otherwise specified.
Establish a rectangular coordinate system in the measurement plane with the origin of coordinates
(i.e. the coordinate axis intersection point) centrally placed in the zone of maximum illumination level
and with the x-axis parallel to the major axis of the illumination pattern. If there is a marked cut-off in
the y-direction, take this as the positive direction. If there is not a marked cut-off in the y-direction,
arbitrarily select a direction to be the positive direction.
For tests specifying visual assessment of the illuminance pattern, place a uniform, neutral, diffusely
reflecting, flat white screen in the measurement plane. For tests requiring instrumented measurements,
place the specified detector in the measurement plane unless otherwise specified.
Perform optical tests in a room where light from other sources and reflected light from room surfaces
are negligible.
If an operating light is designed to be used at a distance other than 700 mm, the manufacturer shall state
the intended operating distance in the instructions for use and include additional optical measurements
at the intended operating distance in the technical description.
7.3.2 Level of illuminance and illuminance pattern
Use the test set-up as described in 7.3.1.
Measure the illuminance levels with a photometer calibrated in accordance with ISO/CIE 19476 and
having an acceptance aperture with a diameter of 10 mm.
ISO 9680:2021(E)
Moving the photometer within the measurement plane, make measurements at rectilinear coordinates
not more than 5 mm apart, such that all points within the illuminance pattern having an illuminance
greater than 600 lx are measured.
A photometer that can indirectly record the illuminance distribution with one measurement, i.e. an
imaging luminance measurement device (ILMD), may be used for this purpose. In such a case, the
illuminance pattern is normally projected onto a flat, uniform, diffusely reflecting screen positioned
in the measurement plane and the luminance distribution of the reflected light measured using the
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