EN ISO 9680:2014
(Main)Dentistry - Operating lights (ISO 9680:2014)
Dentistry - Operating lights (ISO 9680:2014)
ISO 9680:2014 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.
ISO 9680:2014 applies to operating lights, irrespective of the technology of the light source.
ISO 9680:2014 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.
Zahnheilkunde - Behandlungsleuchten (ISO 9680:2014)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Behandlungsleuchten fest, die in der
Zahnarztpraxis verwendet werden und zur Ausleuchtung der Mundhöhle der Patienten vorgesehen sind. Sie
enthält auch Festlegungen an die Gebrauchsanweisung des Herstellers, Kennzeichnung und Verpackung.
Diese Internationale Norm gilt für alle Behandlungsleuchten, unabhängig von der Technologie der
verwendeten Lichtquelle.
Diese Internationale Norm gilt nicht für zusätzliche Lichtquellen, z. B. von zahnärztlichen Handstücken und
zahnärztlichen Stirnlampen und auch Behandlungsleuchten, die speziell zum Einsatz in der Kieferchirurgie
vorgesehen sind.
Médecine bucco-dentaire - Appareils d'éclairage (ISO 9680:2014)
L'ISO 9680:2014 spécifie les exigences et les méthodes d'essai relatives aux appareils d'éclairage utilisés dans les cabinets dentaires et destinés à éclairer la cavité buccale des patients. Elle contient également des spécifications relatives aux instructions d'utilisation du fabricant, au marquage et à l'emballage.
L'ISO 9680:2014 s'applique aux appareils d'éclairage, quelle que soit la technologie de la source lumineuse.
L'ISO 9680:2014 exclut les sources lumineuses auxiliaires, par exemple celles provenant de pièces à main dentaires ou de lampes frontales dentaires, de même que les appareils d'éclairage spécifiquement destinés à être utilisés en chirurgie buccale.
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2014)
Ta mednarodni standard 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 proizvajalca za uporabo, označevanje in pakiranje.
Ta mednarodni standard se uporablja za operacijsko razsvetljavo, ne glede na tehnologijo vira razsvetljave.
Ta mednarodni standard ne zajema pomožnih virov razsvetljave, npr. ki jo oddajajo dentalni ročni pripomočki in dentalne naglavne svetilke ter tudi operacijska razsvetljava, ki je posebej namenjena uporabi med operacijami ustne votline.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
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
ISO 9680:2014(E)
© ISO 2014
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ii © ISO 2014 – All rights reserved
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
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
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