BS EN ISO 9680-2014 Dentistry Operating lights《牙科学 工作灯》.pdf

1、BSI Standards PublicationBS EN ISO 9680:2014Dentistry Operating lightsBS EN ISO 9680:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9680:2014.It supersedes BS EN ISO 9680:2007 which is withdrawn.The UK participation in its preparation was entrusted to

2、TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The

3、 British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 75172 1ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 No

4、vember 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9680 October 2014 ICS 11.060.20 Supersedes EN ISO 9680:2007English Version Dentistry - Operating lights (ISO 9680:2014) Mdecine bucco-dentaire - Appareils dclairage (ISO 9680:201

5、4) Zahnheilkunde - Behandlungsleuchten (ISO 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

6、 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 languag

7、e 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,

8、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

9、STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN ISO 9680:2014 EBS EN ISO 9680:2014E

10、N ISO 9680:2014 (E) 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 stan

11、dard, 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. CE

12、N 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: A

13、ustria, 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, Sw

14、eden, 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. BS EN ISO 9680:2014ISO 9680:2014(E)Contents PageForeword ivIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions .

15、 14 Classification 24.1 According to type of protection against electric shock 24.2 According to mode of operation 25 Requirements and recommendations 25.1 General requirements . 25.2 Optical requirements . 35.3 Mechanical requirements 65.4 Cleaning and disinfection . 75.5 Electrical requirements .

16、75.6 Usability 76 Sampling 77 Testing . 77.1 General . 77.2 Visual inspection . 77.3 Optical tests . 87.4 Mechanical tests 117.5 Cleaning and disinfection 118 Manufacturers instructions 118.1 Documents . 118.2 General 128.3 Instructions for use 128.4 Technical description . 128.5 Check 129 Packaging

17、 1210 Marking .1310.1 Marking on the outside of mains-operated operating lights 1310.2 Marking on the inside of operating lights . 1310.3 Graphical symbols . 1310.4 Colours of the insulation of conductors . 1310.5 Indicator lights and push-buttons . 13Annex A (informative) Transformation formulas 14

18、Annex B (normative) Normalized absorbance of camphorquinone.15Bibliography .17 ISO ISO pub-date year All rights reserved iiiBS EN ISO 9680:2014ISO 9680:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

19、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-g

20、overnmental, 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

21、 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/directivesAttention is drawn to the possi

22、bility 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

23、 patent declarations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as informa

24、tion about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This third edition cancels and replaces the s

25、econd edition (ISO 9680:2007), which has been technically revised via the following changes:a) The scope was expanded to consider any light source technology, including light emitting diodes (LEDs);b) Normative references have been updated;c) The requirement for the adjustable level of illuminance h

26、as been changed to eliminate an upper limit on the minimum illuminance level and to reduce the lower limit on maximum illuminance to 15 000 lx;d) The requirement for the Illumination pattern has been revised to specify a minimum size and shape of the outer area of illumination, area B;e) A requireme

27、nt has been added to measure, plot and report the 10 %, 50 % and 75 % of maximum illuminance isolux lines;f) The CIE chromaticity coordinates for corner point 1 in Table 1 have been changed to set this corner point within 0,02 of the Planckian locus in the CIE 1960 Uniform Chromaticity Space i.e. (u

28、,v) chromaticity space;g) The colour rendering index requirement was revised to exclude LED operating lights since current LED operating lights may not meet the requirement and an accepted method for measuring the colour rendering properties of white LEDs is not yet established;h) In the requirement

29、 for ultraviolet light irradiance the lower limit of the wavelength range was changed from 180 nm to 200 nm in order to reflect the measurement range of available radiometers;i) A requirement for compatibility with light-activated restorative materials has been added;j) The requirement for operating

30、 forces has been simplified;k) The requirement for expelled parts has been revised;iv ISO ISO pub-date year All rights reservedBS EN ISO 9680:2014ISO 9680:2014(E)l) References in electrical requirements were updated and simplified;m) A requirement on usability has been added;n) Requirements for test

31、 conditions have been simplified;o) Electrical tests have been deleted due to reference to IEC 60601-1:2005+A1:2012;p) Optical tests have been clarified and a test for compatibility with light-activated restorative materials has been added;q) The requirements for instructions for use and technical d

32、escription have been revised;r) The requirements for marking on the outside of mains-operated operating lights have been revised;s) The requirement for marking of operating controls has been eliminated in favour of the broader requirement for graphical symbols;t) The Bibliography has been expanded.

33、ISO ISO pub-date year All rights reserved vBS EN ISO 9680:2014ISO 9680:2014(E)IntroductionThe 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, wi

34、thout 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

35、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 International Standard account has been taken of IEC 60598-1.This International Standard refers to IEC 60601-1, the basic standar

36、d on safety of medical electrical equipment, whereever relevant, by stating the respective clause numbers of IEC 60601-1.This International Standard takes priority over IEC 60601-1 as specified in the individual Clauses of this International Standard.Only the specifications laid down in this Interna

37、tional Standard are applicable.vi ISO ISO pub-date year All rights reservedBS EN ISO 9680:2014Dentistry Operating lights1 ScopeThis International Standard specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients.

38、 It also contains specifications on manufacturers instructions for use, marking and packaging.This International Standard applies to operating lights, irrespective of the technology of the light source.This International Standard excludes auxiliary light sources, e.g. from dental handpieces and dent

39、al headlamps and also operating lights which are specifically designed for use in oral surgery.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited appli

40、es. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 4073, Dentistry Information system on the location of dental equipment in the working area of the oral health care providerISO 9687, Dentistry Graphical symb

41、ols for dental equipmentISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 14971, Medical devices Application of risk management to medical devicesISO 21530, Dentistry Materials used for dental equipmen

42、t surfaces Determination of resistance to chemical disinfectantsIEC 60050-845, International Electrotechnical Vocabulary, LightingIEC 60598-1, Luminaires Part 1: General requirements and testsIEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential p

43、erformance + A1:2012IEC 62366, Medical devices Application of usability engineering to medical devicesIEC 62471:2006, Photobiological safety of lamps and lamp systemsIEC 80601-2-60, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental e

44、quipmentCIE 013.3, Method of measuring and specifying colour rendering properties of light sourcesCIE S 017, ILV: International Lighting Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in CIE S 017, IEC 60050-845, IEC 60598-1, IEC 60601-1, ISO 1942

45、, ISO 4073 and the following apply.INTERNATIONAL STANDARD ISO 9680:2014(E) ISO 2014 All rights reserved 1BS EN ISO 9680:2014ISO 9680:2014(E)3.1operating lightdevice designed for use by an operator for illuminating the oral cavity, which distributes, filters and/or transforms the light transmitted fr

46、om 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 supply3.2LED operating lightoperating light using at least one light emitting diode (LED) as the ligh

47、t source3.3illuminanceluminous flux incident on a surface per unit of area, usually measured in lux3.4light-activated restorative materialdental material intended for restoring teeth that incorporates a monomer system, the polymerization of which is activated by blue lightNote 1 to entry: Polymer-ba

48、sed materials of this type are classified in ISO 4049 as Class 2 materials and water-based materials of this type are classified in ISO 9917-2 as Class 2 or Class 3 materials.4 Classification4.1 According to type of protection against electric shockOperating lights are classified in accordance with

49、IEC 60601-1 as follows:a) Class I equipment, see IEC 60601-1;b) Class II equipment, see IEC 60601-1.4.2 According to mode of operationOperating lights shall be suitable for continuous operation. IEC 60601-1:2005+A1:2012, 6.6 applies.5 Requirements and recommendations5.1 General requirementsOperating lights shall be designed, constructed and manufactured so that, when properly transported, stored, installed, used and maintained according to the manufacturers instructions, they cause no danger which could reasonably be foreseen to