EN 60601-2-41-2009 en Medical electrical equipment - Part 2-41 Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosi.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosisBS EN 60601-2-41:2009+A11:2011BS EN 60601-2-41:2009+A1:2015BS EN 60601-2-41:2009+A1:2015 BRITISH STANDARDNational fore

2、wordThis British Standard is the UK implementation of EN 60601-2-41:2009+A1:2015. It is identical to IEC 60601-2-41:2009, incorporating amendment 1:2013. It supersedes BS EN 60601-2-41:2009+A11:2011, which will be withdrawn on 14 April 2018.The start and finish of text introduced or altered by amend

3、ment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice

4、, to Subcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Bri

5、tish Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 75598 9ICS 11.040.20; 11.040.55; 11.040.99Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strate

6、gy Committee on 31 March 2010.Amendments/corrigenda issued since publicationDate Text affected31 March 2012 Implementation of CENELEC amendment A11:2011: Annex ZZ replaced31 July 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE

7、NORM 2011 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means r

8、eserved worldwide for CENELEC members. Ref. No. EN 60601-2-41:2009 E ICS 11.040.20; 11.040.55; 11.040.99 Supersedes EN 60601-2-41:2009English version Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for

9、 diagnosis (IEC 60601-2-41:2009) Appareils lectromdicaux - Partie 2-41: Exigences particulires pour la scurit de base et les performances essentielles des clairages chirurgicaux et des clairages de diagnostic (CEI 60601-2-41:2009) Medizinische elektrische Gerte - Teil 2-41: Besondere Festlegungen fr

10、 die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten (IEC 60601-2-41:2009) This European Standard was approved by CENELEC on 2009-11-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the cond

11、itions 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 Central Secretariat or to any CENELEC member. This European Standard exists in t

12、hree official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechn

13、ical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland an

14、d the United Kingdom. EN 60601-2-41:2009+A11OctoberEN 60601-2-41:2009+A1May 2015Foreword The text of document 62D/773/FDIS, future edition 2 of IEC 60601-2-41, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC paral

15、lel vote and was approved by CENELEC as EN 60601-2-41 on 2009-11-01. This European Standard supersedes EN 60601-2-41:2000. EN 60601-2-41:2000 was revised to be consistent with EN 60601-1:2006. The following dates were fixed: latest date by which the EN has to be implemented at national level by publ

16、ication of an identical national standard or by endorsement (dop) 2010-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-11-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European

17、 Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes,

18、examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbe

19、red divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the

20、term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard co

21、nform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is reco

22、mmended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or ration

23、ale related to that item in Annex AA. BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) 2 BS EN 60601-2-41:2009+A1:2015EN 60601-2-41:2009+A1:2015 (E) 2 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-41:2009 was appro

24、ved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60598-1 NOTE Harmonized as EN 60598-1:2008 (modified). IEC 60598-2-1 NOTE Harmonized as EN 60598-2-1:1989 (not modified). I

25、EC 60598-2-4 NOTE Harmonized as EN 60598-2-4:1997 (not modified). IEC 60598-2-22 NOTE Harmonized as EN 60598-2-22:1998 (modified). IEC 60598-2-25 NOTE Harmonized as EN 60598-2-25:1994 (not modified). ISO 9680 NOTE Harmonized as EN ISO 9680:2007 (not modified) _ Foreword to amendment A11 This documen

26、t (EN 60601-2-41:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. The following dates are fixed: latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-10-01 lat

27、est date by which the national standards conflicting with this document have to be withdrawn (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or

28、all such patent rights. BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) 3 BS EN 60601-2-41:2009+A1:2015EN 60601-2-41:2009+A1:2015 (E) 3 BS EN 60601-2-41:2009+A1:2015EN 60601-2-41:2009+A1:2015 (E) 4 EN 60601-2-41:2009/A1:2015 2 Foreword The text of document 62D/1081/FDIS, future IEC 60

29、601-2-41:2009/A1, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-41:2009/A1:2015. The following dates are fixed: latest date by which the document has to be im

30、plemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some of the elements of this docu

31、ment may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requir

32、ements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-41:2009/A11:2011. Endorsement notice The text of the International Standard IEC 60601-2-41:2009/A1:2013 was approved by CENELEC as a European Standard without any modificatio

33、n. In the Bibliography of EN 60601-2-41:2009, the following note has to be added for the standard indicated: IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified). Foreword to amendment A1Annex ZA (normative) Normative references to international publications with their corresponding E

34、uropean publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international p

35、ublication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Addition: IEC 60417 data-base Graphical symbols for use on equipment - - IEC 60598-2-9 -1)Luminaires - Part

36、2: Particular requirements - Section 9: Photo and film luminaires (non-professional) EN 60598-2-9 19892)ISO 11664-1 -1)Colorimetry - Part 1: CIE standard colorimetric observers - - CIE 13.3 -1)Method of measuring and specifying colour rendering of light sources - - CIE 15 -1)Colorimetry - - CIE 69 -

37、1)Methods of characterizing illuminance meters and luminance meters: Performance, characteristics and specifications - - 1)Undated reference. 2)Valid edition at date of issue. BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) 4 BS EN 60601-2-41:2009+A1:2015EN 60601-2-41:2009+A1:2015 (E)

38、 5 EN 60601-2-41:2009/A1:2015 2 Foreword The text of document 62D/1081/FDIS, future IEC 60601-2-41:2009/A1, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-41:2

39、009/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (do

40、w) 2018-04-14 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the

41、European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-41:2009/A11:2011. Endorsement notice The text of the International Standard IEC 6060

42、1-2-41:2009/A1:2013 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-41:2009, the following note has to be added for the standard indicated: IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified). Annex ZZ (informative) Coverage

43、of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive

44、 93/42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; luminaires used in dentistry, which are covered by ISO 9680; luminaires for general purposes,

45、which are covered by IEC 60598-2-1 and IEC 60598-2-4; luminaires dedicated to therapeutic purposes; special purpose lights with different conditions of use such as UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation

46、 systems; lights connected to surgical instruments; luminaires of an emergency lighting, which are covered by IEC 60598-2-22. NOTE See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANC

47、E requirements for SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS as defined in 201.3. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for th

48、e particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. 1)The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements

49、 for basic safety and essential performance. BS EN 60601-2-41:2009+A11:2011 EN 60601-2-41:2009+A11:2011 (E) 9 BS EN 60601-2-41:2009+A1:2015EN 60601-2-41:2009+A1:2015 (E) 10 1)The general standard is IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance.For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their doc