SIST EN ISO 9680:2015

SLOVENSKI STANDARD
SIST EN ISO 9680:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 9680:2007
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2014)
Dentistry - Operating lights (ISO 9680:2014)
Zahnheilkunde - Behandlungsleuchten (ISO 9680:2014)
Médecine bucco-dentaire - Éclairage opératoire (ISO 9680:2014)
Ta slovenski standard je istoveten z: EN ISO 9680:2014
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
91.160.10 Notranja razsvetljava Interior lighting
SIST EN ISO 9680:2015 de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 9680:2015

---------------------- Page: 2 ----------------------

SIST EN ISO 9680:2015

EUROPEAN STANDARD
EN ISO 9680

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.060.20 Supersedes EN ISO 9680:2007
English Version
Dentistry - Operating lights (ISO 9680:2014)
Médecine bucco-dentaire - Appareils d'éclairage (ISO Zahnheilkunde - Behandlungsleuchten (ISO 9680:2014)
9680:2014)
This European Standard was approved by CEN on 9 August 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9680:2014 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 9680:2015
EN ISO 9680:2014 (E)
Contents Page
Foreword .3
2

---------------------- Page: 4 ----------------------

SIST EN ISO 9680:2015
EN ISO 9680:2014 (E)
Foreword
This document (EN ISO 9680:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9680:2007.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9680:2014 has been approved by CEN as EN ISO 9680:2014 without any modification.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 9680:2015

---------------------- Page: 6 ----------------------

SIST EN ISO 9680:2015
INTERNATIONAL ISO
STANDARD 9680
Third edition
2014-10-15
Dentistry — Operating lights
Médecine bucco-dentaire — Appareils d’éclairage
Reference number
ISO 9680:2014(E)
©
ISO 2014

---------------------- Page: 7 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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 the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
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
5.3 Mechanical requirements . 6
5.4 Cleaning and disinfection . . 7
5.5 Electrical requirements . 7
5.6 Usability . 7
6 Sampling . 7
7 Testing . 7
7.1 General . 7
7.2 Visual inspection . 7
7.3 Optical tests . 8
7.4 Mechanical tests .11
7.5 Cleaning and disinfection . .11
8 Manufacturer’s instructions .11
8.1 Documents .11
8.2 General .12
8.3 Instructions for use .12
8.4 Technical description .12
8.5 Check .12
9 Packaging .12
10 Marking .13
10.1 Marking on the outside of mains-operated operating lights .13
10.2 Marking on the inside of operating lights .13
10.3 Graphical symbols .13
10.4 Colours of the insulation of conductors .13
10.5 Indicator lights and push-buttons .13
Annex A (informative) Transformation formulas .14
Annex B (normative) Normalized absorbance of camphorquinone
.................................................................................15
Bibliography .17
© ISO ISO pub-date year – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.
This third edition cancels and replaces the second edition (ISO 9680:2007), which has been technically
revised via the following changes:
a) The scope was expanded to consider any light source technology, including light emitting diodes (LEDs);
b) Normative references have been updated;
c) The requirement for the adjustable level of illuminance has been changed to eliminate an upper limit
on the minimum illuminance level and to reduce the lower limit on maximum illuminance to 15 000 lx;
d) The requirement for the Illumination pattern has been revised to specify a minimum size and shape
of the outer area of illumination, area B;
e) A requirement has been added to measure, plot and report the 10 %, 50 % and 75 % of maximum
illuminance isolux lines;
f) The CIE chromaticity coordinates for corner point 1 in Table 1 have been changed to set this corner
point within 0,02 of the Planckian locus in the CIE 1960 Uniform Chromaticity Space [i.e. (u,v)
chromaticity space];
g) The colour rendering index requirement was revised to exclude LED operating lights since current
LED operating lights may not meet the requirement and an accepted method for measuring the
colour rendering properties of white LEDs is not yet established;
h) In the requirement for ultraviolet light irradiance the lower limit of the wavelength range was
changed from 180 nm to 200 nm in order to reflect the measurement range of available radiometers;
i) A requirement for compatibility with light-activated restorative materials has been added;
j) The requirement for operating forces has been simplified;
k) The requirement for expelled parts has been revised;
iv © ISO ISO pub-date year – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

l) References in electrical requirements were updated and simplified;
m) A requirement on usability has been added;
n) Requirements for test conditions have been simplified;
o) Electrical tests have been deleted due to reference to IEC 60601-1:2005+A1:2012;
p) Optical tests have been clarified and a test for compatibility with light-activated restorative
materials has been added;
q) The requirements for instructions for use and technical description have been revised;
r) The requirements for marking on the outside of mains-operated operating lights have been revised;
s) The requirement for marking of operating controls has been eliminated in favour of the broader
requirement for graphical symbols;
t) The Bibliography has been expanded.
© ISO ISO pub-date year – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(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 nor affect its qualities adversely.
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, whereever relevant, by stating the respective clause numbers of IEC 60601-1.
This International Standard takes priority over IEC 60601-1 as specified in the individual Clauses of this
International Standard.
Only the specifications laid down in this International Standard are applicable.
vi © ISO ISO pub-date year – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 9680:2015
INTERNATIONAL STANDARD ISO 9680:2014(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 for use, marking and packaging.
This International Standard applies to operating lights, irrespective of the technology of the light source.
This International Standard excludes auxiliary light sources, e.g. 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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 14971, Medical devices — Application of risk management to medical devices
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, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance + A1:2012
IEC 62366, Medical devices — Application of usability engineering to medical devices
IEC 62471:2006, Photobiological safety of lamps and lamp systems
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for basic safety and
essential performance of dental equipment
CIE 013.3, Method of measuring and specifying colour rendering properties of light sources
CIE S 017, ILV: International Lighting Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in CIE S 017, IEC 60050-845,
IEC 60598-1, IEC 60601-1, ISO 1942, ISO 4073 and the following apply.
© ISO 2014 – All rights reserved 1

---------------------- Page: 13 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

3.1
operating light
device designed for use by an operator for illuminating the oral cavity, which distributes, filters and/or
transforms the light 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
LED operating light
operating light using at least one light emitting diode (LED) as the light source
3.3
illuminance
luminous flux incident on a surface per unit of area, usually measured in lux
3.4
light-activated restorative material
dental material intended for restoring teeth that incorporates a monomer system, the polymerization of
which is activated by blue light
Note 1 to entry: Polymer-based materials of this type are classified in ISO 4049 as Class 2 materials and water-
based materials of this type are classified in ISO 9917-2 as Class 2 or Class 3 materials.
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, see IEC 60601-1;
b) Class II equipment, see IEC 60601-1.
4.2 According to mode of operation
Operating lights shall be suitable for continuous operation. IEC 60601-1:2005+A1:2012, 6.6 applies.
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.
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 International Standard, it shall be considered that
these requirements are fulfilled.
Test in accordance with 7.3.
2 © ISO 2014 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(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.
NOTE Manufacturers are advised that there is indication in the dental ergonomics literature that a higher
[14]
specified level of illuminance up to a certain limit may be warranted. This requirement will be evaluated in
the next revision of this Standard and modified with respect to the lower limit and/or upper limit for maximum
illuminance, if appropriate, with consideration for current research.
The adjustment of illuminance may be either continuous or in discrete levels.
Test in accordance with 7.2 and 7.3.2.
5.2.2 Illumination pattern
5.2.2.1 Illumination areas and illuminance levels
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, in which the point of maximum illuminance, L , shall lie. Throughout area A the
Max
illuminance shall not be less than 75 % of L (see Figure 1). Test in accordance with 7.3.2.
Max
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 measured and plotted in accordance with 7.3.2 in
order to indicate area B. 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 (see Figure 1).
The 10 % of maximum illuminance isolux line and 75 % of maximum illuminance isolux line shall
be measured and plotted in accordance with 7.3.2 for the purpose of fulfilling the manufacturer’s
instructions requirement specified in 8.4.
© ISO 2014 – All rights reserved 3

---------------------- Page: 15 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(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
5.2.2.2 Illumination uniformity
The illumination 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
The level of illuminance at all points on or above a horizontal line 60 mm above the centre of area A shall
not be greater than 1 200 lx (see Figure 1).
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.
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.
4 © ISO 2014 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

5.2.5 Correlated colour temperature
Over the full range of illuminance levels of the operating light, the CIE (x,y) chromaticity coordinates
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, defined in CIE 15, of the four corner
points are also given in Table 1.
NOTE The colour space defined by the coordinates in Table 1 corresponds to correlated colour temperatures
between 3 600 K to 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.
Table 1 — Coordinates of colour space
Chromaticity coordinates LUV colour space of CIE 15
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 Radiant heat in pattern
2
The radiant heat in pattern shall be measured as the irradiance, E, in W/m . The irradiance shall
2
be ≤ 350 W/m at the maximum illuminance level.
Test in accordance with 7.3.7.
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 7.3.8.
5.2.8 Colour rendering
For general illumination of the oral cavity, the operating light shall have a colour rendering index R > 85
a
if the operating light is not an LED operating light.
Test in accordance with 7.3.9.
NOTE A performance requirement for the colour rendering index of LED operating lights is not specified
since some current LED operating lights may not meet this requirement and an accepted method for measuring
the colour rendering properties of white LEDs is not yet established. Manufacturers are advised that a colour
rendering requirement for LED operating lights will be considered in the next revision of this Standard.
5.2.9 UV irradiance
The effective UV irradiance at the maximum level of the operating light in the spectral region
2
200 nm to 400 nm shall not exceed 0,008 W/m and shall be in accordance with the requirements of
IEC 62471:2006, 4.3.1.
© ISO 2014 – All rights reserved 5

---------------------- Page: 17 ----------------------

SIST EN ISO 9680:2015
ISO 9680:2014(E)

Test in accordance with 7.3.10.
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.
5.2.10 Compatibility with light-activated restorative materials
If the operating light is equipped with a setting intended for use while h
...