ISO/FDIS 9680

Dentistry -- Operating lights

Médecine bucco-dentaire -- Lampes opératoires

General Information

• Status: Published
• ICS: 11.060.20 - Dental equipment
• Technical Committee: ISO/TC 106/SC 6 - Dental equipment
• Drafting Committee: ISO/TC 106/SC 6/WG 1 - Dental operating light
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 20-Jul-2021
• Completion Date: 20-Jul-2021

RELATIONS

• Revised: ISO 9680:2014 - Dentistry -- Operating lights
• Effective Date: 16-Sep-2017

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9680
ISO/TC 106/SC 6
Dentistry — Operating lights
Secretariat: DIN
Voting begins on: Médecine bucco-dentaire — Lampes opératoires
2021­07­20
Voting terminates on:
2021­09­14
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 9680:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 9680:2021(E)
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© ISO 2021

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ii © ISO 2021 – All rights reserved
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ISO/FDIS 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 .......................................................................................................................................................... 8

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 ................................................................................................................................................................... 9

5.6 Usability ........................................................................................................................................................................................................ 9

6 Sampling ........................................................................................................................................................................................................................ 9

7 Testing ............................................................................................................................................................................................................................. 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Visual inspection ................................................................................................................................................................................... 9

7.3 Optical tests ............................................................................................................................................................................................... 9

7.3.1 Test set­up ............................................................................................................................................................................. 9

7.3.2 Level of illuminance and illuminance pattern .....................................................................................10

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 .........................................................................................................13

7.3.11 Retinal blue light hazard exposure................................................................................................................13

7.3.12 Heat due to optical radiation ..............................................................................................................................15

7.3.13 Compatibility with light-activated restorative materials ...........................................................15

7.4 Mechanical tests ..................................................................................................................................................................................15

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ISO/FDIS 9680:2021(E)

7.4.1 Moving parts .....................................................................................................................................................................15

7.4.2 Stability after positioning ......................................................................................................................................16

7.4.3 Operating force ...............................................................................................................................................................16

8 Manufacturer's instructions ..................................................................................................................................................................16

8.1 Documents ...............................................................................................................................................................................................16

8.2 General ........................................................................................................................................................................................................16

8.3 Instructions for use ..........................................................................................................................................................................16

8.4 Technical description .....................................................................................................................................................................16

8.5 Check ............................................................................................................................................................................................................17

9 Packaging ..................................................................................................................................................................................................................17

10 Marking .......................................................................................................................................................................................................................17

10.1 Marking on the outside of mains-operated operating lights ........................................................................17

10.2 Marking on the inside of operating lights .....................................................................................................................18

10.3 Graphical symbols .............................................................................................................................................................................18

10.4 Colours of the insulation of conductors .........................................................................................................................18

10.5 Indicator lights and push­buttons .......................................................................................................................................18

Annex A (informative) Transformation formulae................................................................................................................................19

Annex B (normative) Normalized absorbance of camphorquinone.................................................................................20

Bibliography .............................................................................................................................................................................................................................22

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ISO/FDIS 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:
— updated normative references;

— updated requirements and test methods for the illumination pattern, illuminance in patient’s eyes,

colour fidelity and photobiological hazards.

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.
© ISO 2021 – All rights reserved v
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ISO/FDIS 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.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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/CIE 11664­1, Colorimetry — Part 1: CIE standard colorimetric observers
ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223­1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories

ISO 17664, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of 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 60598­1, Luminaires — Part 1: General requirements and tests

I EC 6 06 01­1:20 05+A M D1: 2012 , Medical electrical equipment — Part 1: General requirements for basic

safety and essential performance

IEC 62366­1, Medical devices — Part 1: Application of usability engineering to medical devices

IEC 62471:2006/CIE S 009:2002, CIE S 009:2002, Photobiological safety of lamps and lamp systems

IEC/TR 62471­2:2009, Photobiological safety of lamps and lamp systems — Part 2: Guidance on

manufacturing requirements relating to non-laser optical radiation safety

IEC 80601­2­60, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety

and essential performance of dental equipment
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ISO/FDIS 9680:2021(E)
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 terminological 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 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
3.3
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 could

reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in

single­fault 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.
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ISO/FDIS 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

light­activated 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 iso­illuminance 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

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ISO/FDIS 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.
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ISO/FDIS 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.
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ISO/FDIS 9680:2021(E)

The requirements of 5.2.5 do not apply to any operating modes intended only for use while handling

light­activated 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.

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

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.
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

light­activated 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

Group 1 or lower, as specified in IEC 62471:2006
...