BS EN 60601-2-27-2014 Medical electrical equipment Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment《医疗电气设备 心电监测设备.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentBS EN 60601-2-27:2014BS EN 60601-2-27:2014BS EN 60601-2-27:2014 BRITISH STANDARDNational forewordThis British Standard is

2、 the UK implementation of EN 60601-2-27:2014. It is identical to IEC 60601-2-27:2011, incorporating corrigendum 2012. It supersedes BS EN 60601-2-27:2006, which will be withdrawn on 22 August 2017.IEC corrigendum May 2012 inserts Annex ZA and Annex ZZ.The start and finish of text introduced or alter

3、ed by corrigendum is indicated in the text by tags. Text altered by IEC corrigendum May 2012 is indicated in the text by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment.A

4、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 British Standards Institution 2014. Published by BSI Stan

5、dards Limited 2014ISBN 978 0 59724 4ICS 11.040.50Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2014.Amendments/corrigenda issued since publication

6、Date Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-27 August 2014 ICS 11.040.50 Supersedes EN 60601-2-27:2006 English Version Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitorin

7、g equipment (IEC 60601-2-27:2011 + corrigendum May 2012) Appareils lectromdicaux - Partie 2-27: Exigences particulires pour la scurit de base et les performances essentielles des appareils de surveillance dlectrocardiographie (CEI 60601-2-27:2011 + corrigendum Mai 2012) Medizinische elektrische Gert

8、e - Teil 2-27: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Elektrokardiographie-berwachungsgerten (IEC 60601-2-27:2011 + Berichtigung Mai 2012) This European Standard was approved by CENELEC on 2011-05-04. CENELEC members are bound to comply with the

9、 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-CENELEC Management

10、 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 responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same

11、status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithu

12、ania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische

13、 Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-27:2014 E BS EN 60601-2-27:2014Incorporating corrigendum May 2012Appareils lectromdicaux - Partie

14、 2-27: Exigencesparticulires pour la scurit de base et les performancesessentielles des appareils de surveillance dlectrocardiographie (CEI 60601-2-27:2011 + corrigendum Mai 2012)EN 60601-2-27:2014 - 2 - Foreword The text of document 62D/900/FDIS, future edition 3 of IEC 60601-2-27, prepared by SC 6

15、2D, “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 60601-2-27:2014. The following dates are fixed: latest date by which the document has to be implemented at national level by publicat

16、ion of an identical national standard or by endorsement (dop) 2015-02-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-08-22 This document supersedes EN 60601-2-27:2006. In this standard, the following print types are used: Requirements and

17、 definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, 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

18、 AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered 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 cla

19、use (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 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

20、“inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform 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

21、or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; BS EN 60601-2-27:2014EN 60601-2-27:2014 - 2 - Foreword The text of document 62D/900/FDIS, future edition 3 of I

22、EC 60601-2-27, 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 60601-2-27:2014. The following dates are fixed: latest date by which the document has to be implemente

23、d at national level by publication of an identical national standard or by endorsement (dop) 2015-02-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-08-22 This document supersedes EN 60601-2-27:2006. In this standard, the following print t

24、ypes are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, 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,

25、 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 numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means

26、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 term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the

27、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 conform 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

28、 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 recommended but is not mandatory for compliance with this standard; BS EN 60601-2-27:2014- 3 - EN 60601-2-27:2014 “may” is used to describe a permis

29、sible way to achieve compliance with a requirement or test. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) see infor

30、mative Annex ZZ, which is an integral part of this document. 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. Endorsement notice The te

31、xt of the International Standard IEC 60601-2-27:2011+ corrigendum May 2012 was approved by CENELEC as a European Standard without any modification. BS EN 60601-2-27:2014EN 60601-2-27:2014 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European

32、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 publicati

33、on has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of the general standard applies, except as follows: Publication Year Title EN/HD Year Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic s

34、afety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Genera

35、l requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March 2007 2010 Addition: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high fr

36、equency surgical equipment and high frequency surgical accessories EN 60601-2-2 + A11 2009 2011 IEC 60601-2-25 2011 Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs EN 60601-2-251201X IEC 60601-2-49 2011 Medical elect

37、rical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment EN 60601-2-491)201X 1At draft stage. BS EN 60601-2-27:2014EN 60601-2-27:2014 - 4 - Annex ZA (normative) Normative references to international publications

38、 with their corresponding European 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. N

39、OTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of the general standard applies, except as follows: Publication Year Title EN/HD Year Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-

40、2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential perfor

41、mance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March 2007 2010 Addition: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for basic safety a

42、nd essential performance of high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 + A11 2009 2011 IEC 60601-2-25 2011 Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs EN 60601-2-251201

43、X IEC 60601-2-49 2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment EN 60601-2-491)201X 1At draft stage. BS EN 60601-2-27:2014- 5 - EN 60601-2-27:2014 Annex ZZ (informative) Coverage of E

44、ssential 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 93/

45、42/EEC except as follows: Essential Requirement 6a Essential Requirement 7.4 Essential Requirement 7.5 paragraph 2 where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in th

46、is particular standard. 201.2 Normative references Clause 2 of the general standard applies, except as follows: Replacement: BS EN 60601-2-27:2014 8 60601-2-27 IEC:2011 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements

47、contained in the general standard and collateral standards as appropriate for the 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. For brevity, IEC 6060

48、1-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard ad

49、dresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the followin