EN ISO 9680:2021

Dentistry - Operating lights (ISO 9680:2021)

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.

Zahnheilkunde - Behandlungsleuchten (ISO 9680:2021)

Dieses Dokument legt Anforderungen an und Prüfverfahren für Behandlungsleuchten fest, die in der Zahnarztpraxis verwendet werden und die zur Ausleuchtung der Mundhöhle der Patienten vorgesehen sind. Es enthält auch Festlegungen an die Gebrauchsanweisung, Kennzeichnung und Verpackung.
Dieses Dokument ist für alle Behandlungsleuchten anzuwenden, unabhängig von der Technologie der Lichtquelle.
Dieses Dokument ist nicht anzuwenden für zusätzliche Lichtquellen, zum Beispiel von dentalen Handstücken und dentalen Stirnlampen und auch nicht für Behandlungsleuchten, die speziell für die Anwendung in der Kieferchirurgie vorgesehen sind.

Médecine bucco-dentaire - Luminaires opératoires (ISO 9680:2021)

Le présent document spécifie les exigences et les méthodes d’essai relatives aux luminaires opératoires utilisées dans les cabinets dentaires et destinées à éclairer la cavité buccale des patients. Il contient également des spécifications relatives aux instructions d’utilisation, au marquage et à l’emballage.
Le présent document s’applique aux luminaires opératoires, quelle que soit la technologie de la source lumineuse.
Le présent document exclut les sources lumineuses auxiliaires, par exemple celles provenant de pièces à main dentaires ou de lampes frontales dentaires, de même que les luminaires opératoires spécifiquement destinés à être utilisés en chirurgie buccale.

Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2021)

Ta dokument določa zahteve in preskusne metode za operacijsko razsvetljavo, ki se uporablja v zobozdravstveni ambulanti in je namenjena osvetljevanju ustne votline pacientov. Vsebuje tudi specifikacije za navodila za uporabo, označevanje in pakiranje.
Ta dokument se uporablja za operacijsko razsvetljavo, ne glede na tehnologijo vira razsvetljave.
Ta dokument ne zajema pomožnih virov razsvetljave, ki jo na primer oddajajo dentalni ročni pripomočki in dentalne naglavne svetilke ter tudi operacijska razsvetljava, ki je posebej namenjena uporabi med operacijami ustne votline.

General Information

• Status: Published
• Publication Date: 30-Nov-2021
• Withdrawal Date: 29-Jun-2022
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Dec-2021
• Completion Date: 01-Dec-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: SIST EN ISO 9680:2022 - Dentistry - Operating lights (ISO 9680:2021)

Relations

• Replaces: EN ISO 9680:2014 - Dentistry - Operating lights (ISO 9680:2014)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

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
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
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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-act
...