EN IEC 60601-2-2-2018 Medical electrical equipment - ParT 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical .pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical electrical equipmentPart 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesBS EN IEC 60601-2-2:2018EUROPEAN S

2、TANDARD NORME EUROPENNE EUROPISCHE NORM EN IEC 60601-2-2 May 2018 ICS 11.040.30 Supersedes EN 60601-2-2:2009 English Version Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgica

3、l accessories (IEC 60601-2-2:2017) Appareils lectromdicaux - Partie 2-2: Exigences particulires pour la scurit de base et les performances essentielles des appareils dlectrochirurgie courant haute frquence et des accessoires dlectrochirurgie courant haute frquence (IEC 60601-2-2:2017) Medizinische e

4、lektrische Gerte - Teil 2-2: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegerten (IEC 60601-2-2:2017) This European Standard was approved by CENELEC on 2017-05-05. CENELEC members are bound to comply with the CEN/CENELEC Internal

5、 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 Centre or to any CEN

6、ELEC 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 status as the officia

7、l 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, Lithuania, Luxembourg, Mal

8、ta, 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 Elektrotechnische Normung CEN-

9、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 60601-2-2:2018 E National forewordThis British Standard is the UK implementation of EN IEC 6060122:2018. It is

10、 identical to IEC 6060122:2017. It supersedes BS EN 6060122:2009+A11:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/62/4, Electromedical equipment.A list of organizations represented on this committee can be obtained on request to its secreta

11、ry.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 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 89316 2ICS 11.040.30Compliance with a British Standard cannot co

12、nfer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN IEC 6060122:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISC

13、HE NORM EN IEC 60601-2-2 May 2018 ICS 11.040.30 Supersedes EN 60601-2-2:2009 English Version Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:201

14、7) Appareils lectromdicaux - Partie 2-2: Exigences particulires pour la scurit de base et les performances essentielles des appareils dlectrochirurgie courant haute frquence et des accessoires dlectrochirurgie courant haute frquence (IEC 60601-2-2:2017) Medizinische elektrische Gerte - Teil 2-2: Bes

15、ondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegerten (IEC 60601-2-2:2017) This European Standard was approved by CENELEC on 2017-05-05. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the

16、 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 European Stand

17、ard 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. CENELEC members are

18、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 Netherlands, Norway, Pol

19、and, 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 Elektrotechnische Normung CEN-CENELEC Management Centre: Rue d

20、e 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 60601-2-2:2018 E BS EN IEC 6060122:2018EN IEC 60601-2-2:2018 (E) 2 European foreword The text of document 62D/1427/FDIS, future edition 6 of I

21、EC 60601-2-2, 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 IEC 60601-2-2:2018. The following dates are fixed: latest date by which the document has to be implemente

22、d at national level by publication of an identical national standard or by endorsement (dop) 2018-11-18 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2021-05-18 This document supersedes EN 60601-2-2:2009. Attention is drawn to the possibility th

23、at 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 of the International Standard IEC 60602-2-2:2017 was approved by CENELEC as a European Standard without any m

24、odification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60529 NOTE Harmonized as EN 60529. IEC 60601-2-4:2010 NOTE Harmonized as EN 60601-2-4:2011. IEC 60601-2-18:2009 NOTE Harmonized as EN 60601-2-18:2015. BS EN IEC 6060122:2018E

25、N IEC 60601-2-2:2018 (E) 3 Annex ZA (normative) Normative references 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,

26、 only the edition cited applies. For undated references, the latest 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

27、 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 Year Title EN/HD Year Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2:

28、General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests EN 60601-1-2 2015 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Stan

29、dard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007 Publication Year Title EN/HD Year Addition to Annex ZA of EN 60601-1:2006: CISPR 11 2015 Industrial, scientific and medical equipment - Radio-frequency di

30、sturbance characteristics - Limits and methods of measurement EN 55011 2016 IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-3 2006 IEC 61000-4-6 2013 Electromagnetic comp

31、atibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields EN 61000-4-6 2014 BS EN IEC 6060122:2018 2 IEC 60601-2-2:2017 IEC 2017 CONTENTS FOREWORD . 4 INTRODUCTION . 7 Scope, object and related standards . 8 201.1Normative

32、references 9 201.2Terms and definitions 10 201.3General requirements 14 201.4General requirements for testing of ME EQUIPMENT . 15 201.5Classification of ME EQUIPMENT and ME SYSTEMS 15 201.6ME EQUIPMENT identification, marking and documents 15 201.7Protection against electrical HAZARDS from ME EQUIP

33、MENT 20 201.8Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 36 201.9Protection against unwanted and excessive radiation HAZARDS 36 201.10Protection against excessive temperatures and other HAZARDS 36 201.11Accuracy of controls and instruments and protection against hazardous 20

34、1.12outputs 38 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 43 201.13PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 44 201.14Construction of ME EQUIPMENT . 44 201.15ME SYSTEMS 49 201.16Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 49 201.17202 * ELECTROMAGNETIC DIS

35、TURBANCES Requirements and tests 49 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 50 Annexes . 51 Annex AA (informative) Particular guidance and rationale 52 Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by

36、 HF SURGICAL EQUIPMENT 78 Bibliography 87 Index of defined terms used in this particular standard 89 Figure 201.101 Symbol used with an EARTH REFERENCED PATIENT CIRCUIT . 16 Figure 201.102 Symbol used with a HF ISOLATED PATIENT CIRCUIT . 16 Figure 201.103 Circuit suitable for testing compliance to 2

37、01.8.4.101 22 Figure 201.104 Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT CIRCUITS and load between electrodes 25 Figure 201.105 Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT CIRCUITS and a load resistance from ACTIVE ELECTRODE to earth 26 Figure 201.106 Measuremen

38、t of HF LEAKAGE CURRENT for HF ISOLATED PATIENT CIRCUITS 27 Figure 201.107 Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY 28 Figure 201.108 Test apparatus for anchorages of cords of ACTIVE ACCESSORY . 34 Figure 201.109 Measurement of output power MONOPOLAR output . 39 Figure 201.110 Meas

39、urement of output power BIPOLAR output . 40 BS EN IEC 6060122:2018IEC 60601-2-2:2017 IEC 2017 3 Figure 201.111 Method of testing feedback from one active output to another in simultaneous activation . 43 Figure AA.1 Examples of various parts of an HF surgical ME SYSTEM . 54 Figure AA.2 Example of MO

40、NOPOLAR method of HF surgery using a NEUTRAL ELECTRODE 54 Figure AA.3 Example of BIPOLAR method of HF surgery 55 Figure AA.4 CREST FACTOR vs. peak voltage 60 Figure AA.5 Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth at operating frequencies . 64 Figure BB.1 E-FIELD EMISSIONS

41、test setup . 81 Figure BB.2 H-FIELD EMISSIONS test setup 82 Figure BB.3 Conducted EMISSIONS test setup . 83 Figure BB.4 Unit ad hoc test 85 Figure BB.5 Power cord ad hoc test . 86 Figure BB.6 ACCESSORY cord ad hoc test . 86 Table 201.101 Colours of indicator lights and their meaning for HF SURGICAL

42、EQUIPMENT 16 Table 201.102 Maximum output powers in SINGLE FAULT CONDITIONS 42 Table 201.103 Test currents by weight range . 46 Table AA.1 Summary of measured current and durations for 25 TUR procedures . 73 Table AA.2 Summary of measured currents and durations for general surgical procedures 74 Tab

43、le BB.1 Worst case EMISSIONS of spark gap type HF SURGICAL EQUIPMENT . 84 Table BB.2 Worst case EMISSIONS of non-spark gap (modern) HF SURGICAL EQUIPMENT . 84 BS EN IEC 6060122:2018 4 IEC 60601-2-2:2017 IEC 2017 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-2: Parti

44、cular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical comm

45、ittees (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, Technica

46、l 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, governmental

47、 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 agree

48、ments 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 a

49、nd 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 promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum exte