EN IEC 80601-2-71-2018 en Medical electrical equipment - Part 2-71 Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical electrical equipmentPart 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipmentBS EN IEC 80601-2-71:2018EUROPEAN STANDARD NORME EUR

2、OPENNE EUROPISCHE NORM EN IEC 80601-2-71 June 2018 ICS 11.040.55 English Version Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (IEC 80601-2-71:2015) Appareils lectromdicaux -

3、Partie 2-71: Exigences particulires pour la scurit de base et les performances essentielles des appareils dimagerie spectroscopique proche infrarouge (NIRS) (IEC 80601-2-71:2015) Medizinische elektrische Gerte - Teil 2-71: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leist

4、ungsmerkmale von funktionalen Oximetriegerten (IEC 80601-2-71:2015) This European Standard was approved by CENELEC on 2018-02-28. 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 st

5、andard 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 European Standard exists in three official versions (English, French, German). A versio

6、n 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. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, C

7、roatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switze

8、rland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights of exploitation

9、in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN IEC 80601-2-71:2018 E National forewordThis British Standard is the UK implementation of EN IEC 80601271:2018. It is identical to IEC 80601271:2015. The UK participation in its preparation was entrusted to Technical Com

10、mittee CH/62/4, Electromedical equipment.A list of organizations represented on this committee 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

11、 Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 82583 5ICS 11.040.55Compliance 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 June 2018.Amendme

12、nts/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN IEC 80601271:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IEC 80601-2-71 June 2018 ICS 11.040.55 English Version Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essen

13、tial performance of functional near-infrared spectroscopy (NIRS) equipment (IEC 80601-2-71:2015) Appareils lectromdicaux - Partie 2-71: Exigences particulires pour la scurit de base et les performances essentielles des appareils dimagerie spectroscopique proche infrarouge (NIRS) (IEC 80601-2-71:2015

14、) Medizinische elektrische Gerte - Teil 2-71: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegerten (IEC 80601-2-71:2015) This European Standard was approved by CENELEC on 2018-02-28. CENELEC members are bound to comply with the CE

15、N/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 Ce

16、ntre 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 sta

17、tus 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, Lithuani

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

19、ische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN IEC 80601-2-71:2018 E BS EN IEC 80601271:2018EN IEC 80601-2-71:2018 2 European foreword The text

20、 of document 62D/1238/FDIS, future edition 1 of IEC 80601-2-71, prepared by SC 62D “Electromedical equipment“ of IEC/TC 62 “Electrical equipment in medical practice“, and SC 3 “Lung ventilators and related equipment” of ISO/TC 121 “Anaesthetic and respiratory equipment” was submitted to the IEC-CENE

21、LEC parallel vote and approved by CENELEC as EN IEC 80601-2-71:2018. 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) 2018-12-22 latest date by which the national standard

22、s conflicting with the document have to be withdrawn (dow) 2021-06-22 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text

23、 of the International Standard IEC 80601-2-71:2015 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: IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10. IEC 60601-1-11:201

24、0 1)NOTE Harmonized as EN 60601-1-11:2010 (not modified). 1)Superseded by IEC 60601-1-11:2015. BS EN IEC 80601271:2018EN IEC 80601-2-71:2018 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents are referred t

25、o in the text in such a way that some or all of their content constitutes requirements 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 1 Where an International Publi

26、cation 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 annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies except as follows: Publication

27、Year Title EN/HD Year Replacement: IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 - IEC 60825-1 2014 Safety of laser products - Part 1: Equipment classification and requirements EN

28、 60825-1 2014 Addition: IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 - ISO 80601-2-61 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter eq

29、uipment EN ISO 80601-2-61 - ISO/TR 16142 2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices - - BS EN IEC 80601271:2018 2 IEC 80601-2-71:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 201.1 Sc

30、ope, object and related standards 7 201.2 Normative references 9 201.3 Terms and definitions 9 201.4 General requirements 12 201.5 General requirements for testing ME EQUIPMENT 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12 201.7 ME EQUIPMENT identification, marking and documents . 12 2

31、01.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 13 201.10 Protection against unwanted and excessive radiation HAZARDS . 13 201.11 Protection against excessive temperatures and other hazards 13 201.12 ACCURAC

32、Y of controls and instruments and protection against hazardous outputs . 13 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 21 201.15 Construction of ME EQUIPMENT 21 201.16 ME SYSTEMS 21 201.17 Electromagnetic compatibility

33、 of ME EQUIPMENT and ME SYSTEMS . 21 Annexes . 22 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 22 Annex AA (informative) Particular guidance and rationale . 23 Annex BB (normative) Evaluating ME EQUIPMENT performance using the FUNCTIONAL NIRS PHAN

34、TOM . 25 Annex CC (informative) Reference to the essential principles . 34 Bibliography . 36 Index of defined terms 37 Figure 201.101 FULL WIDTH AT HALF MAXIMUM of spectral power distribution 10 Figure 201.102 Measurement of AVERAGE OPTICAL POWER . 14 Figure 201.103 Measurement of PEAK WAVELENGTH an

35、d FWHM . 15 Figure 201.104 Measurement of signal stability 16 Figure 201.105 Measurement of RESPONSE TIME 17 Figure 201.106 Rise time and fall time in RESPONSE TIME . 18 Figure 201.107 Measurement of signal-to-noise ratio 19 Figure 201.108 Measurement of SIGNAL CROSS-TALK 21 Figure 201.BB.1 The FUNC

36、TIONAL NIRS PHANTOM in two states with different detected light intensities . 28 Figure BB.2 FUNCTIONAL NIRS PHANTOM measurement using the reference system 29 BS EN IEC 80601271:2018IEC 80601-2-71:2015 IEC 2015 3 Figure BB.3 FUNCTIONAL NIRS PHANTOM measurement using the ME EQUIPMENT to be evaluated

37、. 29 Figure BB.4 Schematic for measurement of OPTICAL LOSS . 32 Table 201.101 Performance tests employing the FUNCTIONAL NIRS PHANTOM or attenuator and the required OPTICAL LOSS 13 Table 201.C.101 Marking on the outside of FUNCTIONAL NIRS EQUIPMENT or their parts 22 Table 201.C.102 ACCOMPANYING DOCU

38、MENTS, instructions for use of FUNCTIONAL NIRS EQUIPMENT 22 Table CC.1 Correspondence between this particular standard and the essential principles 34 BS EN IEC 80601271:2018 4 IEC 80601-2-71:2015 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-71: Particular

39、 requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Com

40、mittees). 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, Technical Reports, Publicly Avai

41、lable 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, governmental and non-governmental or

42、ganizations 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 agreements of IEC on technica

43、l 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 and are accepted by IEC N

44、ational 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 promote international uniformit

45、y, 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 indicated in the latter. 5) IEC

46、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) All users should ensure th

47、at 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 or other damage of any na

48、ture 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 publication. Use of the referenc

49、ed 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 80601-2-71 has been prepared by a Joint Working Group of IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equ