EN 60601-1-2-2015 en Medical electrical equipment - Part 1-2 General requirements for basic safety and essential performance - Collateral Standard Electromagnetic disturbances - Re.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and testsBS EN 60601-1-2:2015National forewordThis British Standard is the UK implementation of EN 60601-1-2:2

2、015. It isidentical to IEC 60601-1-2:2014. It supersedes BS EN 60601-1-2:2007, whichwill be withdrawn on 31 December 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/1, Common aspects of Electrical

3、Equipment used inMedical Practice.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institut

4、ion 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 58060 4ICS 11.040.01; 33.100.10; 33.100.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October

5、 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-1-2:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-1-2 September 2015 ICS 11.040.01; 33.100.10; 33.100.20 Supersedes EN 60601-1-2:2007 English Version Medical electrical equipment - Part

6、 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014) Appareils lectromdicaux - Partie 1-2: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale:

7、Perturbations lectromagntiques - Exigences et essais (IEC 60601-1-2:2014) Medizinische elektrische Gerte - Teil 1-2: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Elektromagnetische Strgren - Anforderungen und Prfungen (IEC 60601-1-2:2014

8、) This European Standard was approved by CENELEC on 2014-04-01. CENELEC 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 bibliographica

9、l references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibili

10、ty of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, For

11、mer Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechni

12、cal Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No.

13、EN 60601-1-2:2015 E BS EN 60601-1-2:2015EN 60601-1-2:2015 2 European foreword The text of document 62A/916/FDIS, future edition 4 of IEC 60601-1-2, prepared by SC 62A, “Common aspects of electrical equipment used in medical practice“, of IEC/TC 62 “Electrical equipment in medical practice“ was submi

14、tted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-2:2015. 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) 2016-03-18 latest date by which the na

15、tional standards conflicting with the document have to be withdrawn (dow) 2018-12-31 This document supersedes EN 60601-1-2:2007. 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

16、identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 60601-1-2:2014 was approved 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

17、: IEC 60601-1-2:2007 NOTE Harmonized as EN 60601-1-2:2007 (not modified) IEC 60601-2-27:2011 NOTE Harmonized as EN 60601-2-27:2006 (not modified) IEC 60601-2-44:2009 NOTE Harmonized as EN 60601-2-44:2009 (not modified) IEC 61000-3-11:2000 NOTE Harmonized as EN 61000-3-11:2000 (not modified) IEC 6100

18、0-3-12:2011 NOTE Harmonized as EN 61000-3-12:2011 (not modified) IEC 61000-3-12:2011 NOTE Harmonized as EN 61000-3-12:2011 (not modified) IEC 60601-6-1:2005 NOTE Harmonized as EN 60601-6-1:2007 (not modified) IEC 60601-6-2:2005 NOTE Harmonized as EN 60601-6-2:2005 (not modified) IEC 61496-1:2008 NOT

19、E Harmonized as EN 61496-1:2008 (not modified) CISPR 16-1-1:2010 NOTE Harmonized as EN 55016-1-1:2010 (not modified) CISPR 16-2-3:2010 NOTE Harmonized as EN 55016-2-3:2010 (not modified) CISPR 24:2010 NOTE Harmonized as EN 55024:2010 (not modified) CISPR 25:2008 NOTE Harmonized as EN 55025:2008 (not

20、 modified) ISO 17025:2005 NOTE Harmonized as EN ISO/IEC 17025:2005 (not modified) BS EN 60601-1-2:2015EN 60601-1-2:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normative

21、ly referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. However, for any use of this standard “within the meaning of Annex

22、 ZZ“, the user must always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a normative reference

23、 to the parallel EN standard, as outlined below, including the foreword and the Annexes ZZ. NOTE 1 The way in which referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. NOTE 2 When an international publication has been modified by

24、common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD and IEC/ISO Year IEC 60417 Data base Graphical symbols for use on equipment available from http:/www.graphical-symbols.info/equipment IEC 60417 2004 IEC 60601-1 A1 2005 2012 Medical electrical equipmen

25、t Part 1: General requirements for basic safety and essential performance EN 60601-1 A1 2006 2013 IEC 60601-1-8 A1 20062013 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm

26、 systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March A1 2007 2010 2013 IEC 60601-1-11 2010Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical e

27、quipment and medical electrical systems used in the home healthcare environment EN 60601-1-11 2010 IEC 60601-1-12 2014Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medic

28、al electrical systems intended for use in the emergency medical services environment IEC 60601-2-2 2010Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high BS EN 60601-1-2:2015EN 60601-1-2:2015 4 Publication Year Title EN/HD and IEC/IS

29、O Year frequency surgical equipment and high frequency surgical accessories IEC 60601-2-3 2012Medical electrical equipment Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment IEC 61000-3-2 A1 A2 2005 2008 2009 Electromagnetic compatibility

30、 (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current 25 V a.c. Therefore, the ME EQUIPMENT or ME SYSTEM is tested at the minimum and maximum RATED voltage. The RATED voltage range is 220 V a.c. to 240 V a.c. 240 V a.c. 220 V a.c. = 20 V a.c. (range) 25 % of 220

31、V a.c. is 55 V a.c. 20 V a.c. 55 V a.c. Therefore, the ME EQUIPMENT or ME SYSTEM is tested at one voltage within the RATED range. d)ME EQUIPMENT and ME SYSTEMS with power input voltage selection by transformer taps shall be tested at only one tap setting. 5 ME EQUIPMENT and ME SYSTEMS identification

32、, marking and documents 5.1 Additional requirements for marking on the outside of ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location SPECIAL ENVIRONMENT In addition to the requirements of 7.2 of the general standard, ME EQUIPMENT and ME SYSTEMS specified for use only

33、in a shielded location SPECIAL ENVIRONMENT shall be labelled with a CLEARLY LEGIBLE warning that they should be used only in the specified type of shielded location. Compliance is checked by inspection of the ME EQUIPMENT or ME SYSTEM. 5.2 ACCOMPANYING DOCUMENTS 5.2.1 Instructions for use 5.2.1.1 *

34、General In addition to the requirements of 7.9.2 of the general standard, the instructions for use shall include the following: a) * a statement of the environments for which the ME EQUIPMENT or ME SYSTEM is suitable. Relevant exclusions, as determined by RISK ANALYSIS, shall also be listed, e.g. hospitals BS EN 60601-1-2:2015