DIN EN ISO 9680-2015 Dentistry - Operating lights (ISO 9680 2014) German version EN ISO 9680 2014《牙科 工作灯(ISO 9680-2014) 德文版本EN ISO 9680-2014》.pdf

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1、February 2015 Translation by DIN-Sprachendienst.English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 11.060.20!%B“2293104www.din.deDDIN EN ISO 9680Dentistry Operating lights (ISO 9680:2014);English version EN ISO 9680:2014,English translation of DIN EN ISO 9680:2015-02Zahnheilkunde Behandlungsleuchten (ISO 9680:2014);Englische Fassung EN ISO 9680:2014,Englische bersetzung von DIN EN ISO 9680:201

3、5-02Mdecine bucco-dentaire Appareils declairage (ISO 9680:2014);Version anglaise EN ISO 9680:2014,Traduction anglaise de DIN EN ISO 9680:2015-02SupersedesDIN EN ISO 9680:2007-09www.beuth.deDocument comprises 25 pagesIn case of doubt, the German-language original shall be considered authoritative.02.

4、15DIN EN ISO 9680:2015-02 2 A comma is used as the decimal marker. National 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” (Secretariat: DIN, Germany). The responsible German bo

5、dy involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-05-05 AK Behandlungsleuchten of NA 014-00-05 AA Zahnrztliche Ausrstung. The DIN Standards corresponding to the International Standards referred to in this document are a

6、s follows: ISO 1942 DIN EN ISO 1942 ISO 4073 DIN EN ISO 4073 ISO 9687 DIN EN ISO 9687 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 21530 DIN EN ISO 21530 IEC 60598-1 DIN EN 60598-1 IEC 60601-1 DIN EN 60601-1 IEC 62366 DIN EN 62366 IEC 80601-2-60 DIN ISO 80601-2-60 Amendments This st

7、andard differs from DIN EN ISO 9680:2007-09 as follows: a) the scope has been 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 has been changed to eliminate

8、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 requirement has been added to measur

9、e, 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, v) chromaticity space; g

10、) the colour rendering index requirement was revised to exclude LED operating lights since current LED operating lights do 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 for ultraviolet light i

11、rradiance 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; DIN EN ISO 9680:2015-02 3 j) the requirement for opera

12、ting forces has been simplified; k) the requirement for expelled parts has been revised; l) references in electrical requirements have been updated and simplified; m) a requirement on usability has been added; n) requirements for test conditions have been simplified; o) electrical tests have been de

13、leted 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 description have been revised; r) the requirements for marking o

14、n 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. Previous editions DIN EN ISO 9680: 1996-05, 2007-09 DIN EN I

15、SO 9680:2015-02 4 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 4073, Dental equipment Items of dental equipment at the working place Identification system DIN EN ISO 9687, Dental equipment Graphical symbols DIN EN ISO 14971, Medical devices Applicatio

16、n of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 21530, Dentistry Materials used for dental equipment surfaces Determination of resistance to che

17、mical disinfectants DIN EN 60598-1, Luminaires Part 1: General requirements and tests DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN ISO 806

18、01-2-60, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9680 October 2014 ICS 11.060.20 Supersedes EN ISO 9680:2007English Version Dentistry - Operating lights (IS

19、O 9680:2014) Mdecine bucco-dentaire - Appareils dclairage 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

20、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 (En

21、glish, 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

22、, 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, Switzerla

23、nd, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR 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 Me

24、mbers. Ref. No. EN ISO 9680:2014 E(ISO 9680:2014) Contents PageForeword .3Introduction .41 Scope .52 Normative references 53 Terms and definitions .54 Classification 64.1 According to type of protection against electric shock 64.2 According to mode of operation 65 Requirements and recommendations65.

25、1 General requirements .65.2 Optical requirements .75.3 Mechanical requirements .105.4 Cleaning and disinfection 115.5 Electrical requirements 115.6 Usability .116 Sampling .117 Testing 117.1 General 117.2 Visual inspection 117.3 Optical tests 127.4 Mechanical tests 157.5 Cleaning and disinfection 1

26、58 Manufacturers instructions 158.1 Documents .158.2 General 168.3 Instructions for use 168.4 Technical description .168.5 Check 169 Packaging 1610 Marking .1710.1 Marking on the outside of mains-operated operating lights 1710.2 Marking on the inside of operating lights .1710.3 Graphical symbols .17

27、10.4 Colours of the insulation of conductors .1710.5 Indicator lights and push-buttons .17Annex A (informative) Transformation formulas .Annex B (normative) Normalized absorbance of camphorquinone19Bibliography .21EN ISO 9680:2014 (E) DIN EN ISO 9680:2015-02 218Foreword This document (EN ISO 9680:20

28、14) 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 endor

29、sement, 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 identifyi

30、ng 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,

31、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. Endorsemen

32、t notice The text of ISO 9680:2014 has been approved by CEN as EN ISO 9680:2014 without any modification. EN ISO 9680:2014 (E) DIN EN ISO 9680:2015-02 3IntroductionThe aim of this International Standard is to provide the dentist and his staff with means to enable them to work with optimum visual eas

33、e 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 in

34、corporated 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 International Standard account has been taken of IEC 60

35、598-1.This International Standard refers to IEC 60601-1, the basic standard 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 thi

36、s International Standard.Only the specifications laid down in this International Standard are applicable.EN ISO 9680:2014 (E) DIN EN ISO 9680:2015-02 41 ScopeThis International Standard specifies requirements and test methods for operating lights used in the dental office and intended for illuminati

37、ng the oral cavity of patients. 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.

38、from dental handpieces and dental 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 reference

39、s, only the edition cited applies. 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

40、 9687, Dentistry Graphical symbols 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 Mat

41、erials used for dental equipment 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 f

42、or basic safety and essential performance + 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 es

43、sential performance of dental equipmentCIE 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

44、 60598-1, IEC 60601-1, ISO 1942, ISO 4073 and the following apply.EN ISO 9680:2014 (E) DIN EN ISO 9680:2015-02 53.1operating lightdevice 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

45、 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 light source3.3illuminancelumino

46、us 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-based materials of this type a

47、re 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 IEC 60601-1 as follows:a) Cl

48、ass 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, c

49、onstructed 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 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.If the equipment passes all the tests described in this International