oSIST prEN ISO 9680:2021

Dentistry - Operating lights (ISO/DIS 9680:2021)

Zahnheilkunde - Behandlungsleuchten (ISO/DIS 9680:2021)

Médecine bucco-dentaire - Lampes opératoires (ISO/DIS 9680:2021)

Zobozdravstvo - Operacijska razsvetljava (ISO/DIS 9680:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 24-Mar-2021
• ICS: 11.060.20 - Dental equipment
• ICS: 91.160.10 - Interior lighting
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 10-Feb-2021
• Due Date: 30-Jun-2021
• Completion Date: 22-Mar-2021
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Ref Project: prEN ISO 9680 - Dentistry - Operating lights (ISO/DIS 9680:2021)

RELATIONS

• Revised: SIST EN ISO 9680:2015 - Dentistry - Operating lights (ISO 9680:2014)
• Effective Date: 01-Mar-2021

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 9680:2021
01-marec-2021
Zobozdravstvo - Operacijska razsvetljava (ISO/DIS 9680:2021)
Dentistry - Operating lights (ISO/DIS 9680:2021)
Zahnheilkunde - Behandlungsleuchten (ISO/DIS 9680:2021)
Médecine bucco-dentaire - Lampes opératoires (ISO/DIS 9680:2021)
Ta slovenski standard je istoveten z: prEN ISO 9680
ICS:
11.060.20 Zobotehnična oprema Dental equipment
91.160.10 Notranja razsvetljava Interior lighting
oSIST prEN ISO 9680:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 9680:2021
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oSIST prEN ISO 9680:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9680
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-01-26 2021-04-20
Dentistry — Operating lights
Médecine bucco-dentaire — Appareils d'éclairage
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 9680:2021(E)
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 SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 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
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 9680:2021
ISO/DIS 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 ................................................................................................................................. 5

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

5.3.6 Suspended masses.......................................................................................................................................................... 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 set-up ............................................................................................................................................................................. 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

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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)

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

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

7.4.2 General stability.............................................................................................................................................................16

7.4.3 Stability after positioning ......................................................................................................................................16

7.4.4 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 push-buttons .......................................................................................................................................18

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

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

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

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oSIST prEN ISO 9680:2021
ISO/DIS 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.

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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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)
Introduction

The aim of this document 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 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.
In preparing this document account has been taken of IEC 60598-1.

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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oSIST prEN ISO 9680:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 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 manufacturers'

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, 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 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 11664-1, Colorimetry — Part 1: CIE standard colorimetric observers

ISO/CIE 11664-5, Colorimetry — Part 5: CIE 1976 L*u*v* colour space and u', v' uniform chromaticity

scale diagram

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 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 60598-1, Luminaires — Part 1: General requirements and tests

I EC 6 06 01-1:20 05/A M D1: 2012 , 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 62471-2:2009, Photobiological safety of lamps and lamp systems — Part 2: Guidance on manufacturing

requirements relating to non-laser optical radiation safety

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

and essential performance of dental equipment
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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)
CIE S 017, ILV: International Lighting Vocabulary
CIE 224, Colour Fidelity Index for accurate scientific use
3 Terms and definitions

For the purposes of this document, the terms and definitions given in CIE S 017, IEC 60598-1, IEC 60601-1,

ISO 1942, ISO 4073 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 http:// 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
3.2
LED operating light

operating light (3.1) using at least one light emitting diode (LED) as the light source

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 60601-1:2005/AMD 1:2012 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 60601-1:2005/AMD 1:2012 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.

Operating lights shall be capable of being adjusted so as to permit illumination of the oral cavity in all

patient operating positions.
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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)

If the equipment passes all the tests described in this document, it shall be considered that these

requirements are fulfilled.
Test in accordance with 7.2.
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

v, max

the 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 lluminance 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.

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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)
Dimensions in millimetres
Key
A area A, inner area of illumination

Figure 1 — Example of illumination pattern which satisfies the requirement for area A

Dimensions in millimetres
Key
B area B, outer area of illumination

Figure 2 — Example of illumination pattern which satisfies the requirement for area B

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.
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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)
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.
Dimensions in millimetres
Key

C area C, 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,

defined in ISO/CIE 11664-1, within areas A and B of the illuminance pattern shall be within the

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oSIST prEN ISO 9680:2021
ISO/DIS 9680:2021(E)

quadrilateral area bounded by the coordinates in Table 1. The CIE (u’,v’) chromaticity coordinates,

defined in ISO/CIE 11664-5, 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 w
...