BS EN 60601-2-49-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment《医疗用电气设备 多功能病.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-49: Particular requirements for the basic safety and essential performance of multifunctionpatient monitoring equipmentBS EN 60601-2-49:2015National forewordThis British Standard is the UK implementation of EN 60601-2-49:2015. It is identic

2、al to IEC 60601-2-49:2011. It supersedes BS EN 60601-2-49:2001, which will be withdrawn on 15 September 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organiz

3、ations 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 Institution 2015.Published by BSI Standards Limited 2015ISB

4、N 978 0 580 59727 5ICS 11.040.55 Compliance 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 November 2015.Amendments/corrigenda issued since publicationDate Text affectedB

5、RITISH STANDARDBS EN 60601-2-49:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-49 October 2015 ICS 11.040.55 Supersedes EN 60601-2-49:2001 English Version Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifuncti

6、on patient monitoring equipment (IEC 60601-2-49:2011) Appareils lectromdicaux - Partie 2-49: Exigences particulires pour la scurit de base et les performances essentielles des appareils de surveillance multifonction des patients (IEC 60601-2-49:2011) Medizinische elektrische Gerte - Teil 2-49: Beson

7、dere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenberwachungsgerten (IEC 60601-2-49:2011) This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations whic

8、h 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 Centre or to any CENELEC member. This

9、 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 status as the official versions. CENEL

10、EC 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, Lithuania, Luxembourg, Malta, the Netherlan

11、ds, 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 Normung CEN-CENELEC Management Centre

12、: 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. EN 60601-2-49:2015 E BS EN 60601-2-49:2015EN 60601-2-49:2015 2 European foreword The text of document 62D/886/FDIS, future edition 2 of IEC 60601-

13、2-49, 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 60601-2-49:2015. The following dates are fixed: latest date by which the document has to be implemented at nationa

14、l level by publication of an identical national standard or by endorsement (dop) 2016-06-15 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-09-15 This document supersedes EN 60601-2-49:2001. Attention is drawn to the possibility that some of

15、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 European Commission and the European Free Trade Association, and

16、supports essential requirements of EU Directive(s). For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-49:2011 was approved by CENELEC as a European Standard wit

17、hout any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 80601-2-56 NOTE Harmonized as EN 80601-2-56. IEC 62366 NOTE Harmonized as EN 62366. BS EN 60601-2-49:2015EN 60601-2-49:2015 3 Annex ZA (normative) Normative referen

18、ces to international publications with their corresponding European publications The 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 applies. For undated references, the late

19、st edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this

20、annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform

21、ance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigendum Mar. 2010 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, te

22、sts and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007 - - + corrigendum Mar. 2010 ISO 15223-1 2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements -

23、- BS EN 60601-2-49:2015EN 60601-2-49:2015 4 Publication Year Title EN/HD Year Addition to Annex ZA of EN 60601-1:2006: IEC 60601-2-2 2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high freq

24、uency surgical accessories EN 60601-2-2 2009 - - + A11 2011 IEC 60601-2-27 2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment EN 60601-2-27 2014 IEC 60601-2-34 2011 Medical electrical equi

25、pment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment EN 60601-2-34 2014 BS EN 60601-2-49:2015EN 60601-2-49:2015 5 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has

26、 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 given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this

27、 standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-49:2015 2 60601-2-49 IEC:2011 CONTENTS FOREWORD

28、 . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements 11 201.5 General requirements for testing of ME EQUIPMENT . 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identif

29、ication, marking and documents 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 14 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 16 201.10 Protection against unwanted and excessive radiation HAZARDS 16 201.11 Protection against excessive temperatures an

30、d other HAZARDS 16 201.12 Accuracy of controls and instruments and protection against hazardous outputs 17 201.13 HAZARDOUS SITUATIONS and fault conditions . 18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Construction of ME EQUIPMENT . 18 201.16 ME SYSTEMS 18 201.17 Electromagn

31、etic compatibility of ME EQUIPMENT and ME SYSTEMS . 18 202 Electromagnetic compatibility Requirements and tests . 18 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 26 Annexes . 32 Annex AA (informative) General guidance a

32、nd rationale 33 Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 43 ANNEX CC (informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT 46 Bibliography 49 Index of defined terms used in this

33、 particular standard 50 Figure 202.101 Test layout for conducted and radiated emission and radiated immunity test with non-conductive APPLIED PART . 20 Figure 202.102 Test layout for radiated and conducted emission test and radiated immunity test with a PATIENT CONNECTION 21 Figure 202.103 Test circ

34、uit for HF surgery protection measurement according to subclause 202.6.2.1.101 with PATIENT CONNECTIONS 24 Figure 202.104 Test setup for HF surgery protection measurement according to subclause 202.6.2.1.101 . 25 Figure 202.105 Test circuit for HF surgery protection measurement according to subclaus

35、e 202.6.2.1.101 with non-conductive APPLIED PART 26 Figure AA.1 Single APPLIED PART with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS 35 BS EN 60601-2-49:201560601-2-49 IEC:2011 3 Figure AA.2 Single APPLIED PART (6) with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS and multiple APPLIED PARTS (7) with SI

36、NGLE FUNCTIONS and PATIENT CONNECTIONS 36 Figure BB.1 NON-LATCHING ALARM SIGNALS without ALARM RESET 43 Figure BB.2 NON-LATCHING ALARM SIGNALS with ALARM RESET . 44 Figure BB.3 LATCHING ALARM SIGNALS with ALARM RESET . 44 Figure BB.4 Two ALARM CONDITIONS with ALARM RESET . 45 Figure CC.1 PART LEAKAG

37、E CURRENT measurement of TYPE BF APPLIED PARTS with MULTIPLE FUNCTIONS 46 Figure CC.2 PART LEAKAGE CURRENT measurement of TYPE CF APPLIED PARTS with MULTIPLE FUNCTIONS 47 Figure CC.3 Total PATIENT LEAKAGE CURRENT of TYPE BF and CF APPLIED PARTS with MULTIPLE FUNCTIONS caused by an external voltage o

38、n the PATIENT CONNECTIONS 48 Table 201.101 ESSENTIAL PERFORMANCE requirements . 11 Table 208.101 ALARM CONDITION priorities 27 Table 208.102 Characteristics of the BURST of auditory ALARM SIGNALS 28 BS EN 60601-2-49:2015 4 60601-2-49 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECT

39、RICAL EQUIPMENT Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical com

40、mittees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technic

41、al Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmenta

42、l and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agre

43、ements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use

44、and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promot

45、e international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicat

46、ed in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) A

47、ll users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage

48、or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publica

49、tion. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-49 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice