EN ISO 9680:2007
(Main)Dentistry - Operating lights (ISO 9680:2007)
Dentistry - Operating lights (ISO 9680:2007)
ISO 9680:2007 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, marking and packaging.
ISO 9680:2007 applies to operating lights that are intended to be permanently fixed to the ceiling, or to the wall or to the floor.
Zahnheilkunde - Behandlungsleuchten (ISO 9680:2007)
Diese Internationale Norm legt Anforderungen an und Prüfverfahren für Behandlungsleuchten fest, die zur Ausleuchtung der Mundhöhle von Patienten vorgesehen sind. Sie enthält auch Festlegungen für die Gebrauchsanweisung des Herstellers, Kennzeichnung und Verpackung.
Diese Internationale Norm gilt für Behandlungsleuchten, die an der Decke, an den Wänden oder auf dem Boden dauerhaft befestigt werden.
Ausgenommen sind zusätzliche Lichtquellen, z. B. von zahnärztlichen Handstücken und zahnärztlichen Stirnlampen.
Ausgenommen sind ferner Dentalleuchten, die speziell zum Einsatz in einer chirurgischen Praxis vorgesehen sind.
Art dentaire - Appareils d'éclairage (ISO 9680:2007)
L'ISO 9680:2007 spécifie les exigences et les méthodes d'essai pour les 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 du fabricant, au marquage et à l'emballage.
L'ISO 9680:2007 s'applique aux appareils d'éclairage qui sont destinés à être fixés en permanence au plafond, au mur ou au sol.
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2007
1DGRPHãþD
SIST EN ISO 9680:2000
Zobozdravstvo - Operacijska razsvetljava (ISO 9680:2007)
Dentistry - Operating lights (ISO 9680:2007)
Zahnheilkunde - Zahnärztliche Behandlungsleuchte (ISO 9680:2007)
Art dentaire - Appareils d'éclairage (ISO 9680:2007)
Ta slovenski standard je istoveten z: EN ISO 9680:2007
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 9680
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2007
ICS 11.060.20 Supersedes EN ISO 9680:1996
English Version
Dentistry - Operating lights (ISO 9680:2007)
Art dentaire - Appareils d'éclairage (ISO 9680:2007) Zahnheilkunde - Behandlungsleuchten (ISO 9680:2007)
This European Standard was approved by CEN on 9 June 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9680:2007: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 9680:2007) 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 December 2007, and conflicting national
standards shall be withdrawn at the latest by December 2007.
This document supersedes EN ISO 9680:1996.
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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 9680:2007 has been approved by CEN as EN ISO 9680:2007 without any
modifications.
INTERNATIONAL ISO
STANDARD 9680
Second edition
2007-06-15
Dentistry — Operating lights
Art dentaire — Appareils d'éclairage
Reference number
ISO 9680:2007(E)
©
ISO 2007
ISO 9680:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 9680:2007(E)
Contents Page
Foreword. iv
Introduction . v
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 . 3
5 Requirements and recommendations .3
5.1 General requirements. 3
5.2 Optical requirements. 3
5.3 Mechanical requirements. 6
5.4 Cleaning and disinfection . 7
5.5 Electrical requirements . 7
6 Sampling. 8
7 Testing . 9
7.1 General. 9
7.2 Test conditions . 9
7.3 Visual inspection . 11
7.4 Optical tests . 11
7.5 Mechanical tests . 14
7.6 Cleaning and disinfection . 14
7.7 Electrical tests. 14
8 Manufacturer's instructions. 15
8.1 Documents . 15
8.2 General. 15
8.3 Instructions for use . 15
8.4 Technical description. 15
8.5 Check . 15
9 Packaging . 15
10 Marking . 16
10.1 Marking on the outside of mains-operated operating lights. 16
10.2 Marking on the inside of operating lights . 16
10.3 Marking of operating controls . 16
10.4 Graphical symbols. 16
10.5 Colours of insulation conductors . 16
10.6 Indicator lights and push-buttons. 16
Annex A (informative) Transformation formulae . 17
Bibliography . 18
ISO 9680:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 9680 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 9680:1993) and ISO 9680:1993/Cor.1:1995
which have been technically revised via the following changes:
a) the illumination pattern has been changed from a round area, A, with a diameter of 50 mm into an ellipse
with a horizontal axis of 50 mm and a vertical axis of 25 mm;
b) the level of illuminance shall be adjustable with a minimum level u 8 000 lx and a maximum level
W 20 000 lx;
c) a requirement for the general colour rendering index (Ra > 85) for diagnostic purposes is added;
d) a requirement for UV irradiance has been added;
2 2
e) the radiant heat in pattern shall be measured as the irradiance, E, in W/m (E u 350 W/m ).
iv © ISO 2007 – All rights reserved
ISO 9680:2007(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.
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, wherever relevant, by stating the respective clause numbers of IEC 60601-1.
This International Standard takes priority over IEC 60601-1 as specified in its individual clauses.
Only the specifications laid down in this International Standard are applicable.
INTERNATIONAL STANDARD ISO 9680:2007(E)
Dentistry — Operating lights
1 Scope
This International Standard specifies requirements and test methods for operating lights used in the
...
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