BS PD IEC TR 60601-4-2-2016 Medical electrical equipment Guidance and interpretation Electromagnetic immunity performance of medical electrical equipment and medical electrical sys.pdf

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1、Medical electrical equipmentPart 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systemsPD IEC/TR 60601-4-2:2016BSI Standards PublicationNational forewordThis Published Document is the UK implementation of IEC/TR60601-4-2:

2、2016.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 Equipment used inMedical Practice.A list of organizations represented on this committee can be obtained onrequest to

3、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 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 88577 8ICS 11.040.01; 33.100.20Compliance with a Briti

4、sh Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 May 2016.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD IEC/TR 60601-4-2:2016IEC TR 60601-4-2 E

5、dition 1.0 2016-05 TECHNICAL REPORT Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01; 33.100.20 ISBN 978-2-8322-3414-3 Regist

6、ered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colourinsidePD IEC/TR 60601-4-2:2016 2 IEC TR 60601-4-2:2016 IEC 2016 CONTENTS FOREWORD . 5 INTRODUCTION . 8 0.1 * General 8 0.2 Purpose of this docum

7、ent 8 0.3 How to use this document . 8 0.4 IMMUNITY TEST LEVELS 9 1 Scope and object . 10 1.1 Scope . 10 1.2 Object . 10 2 Normative references. 10 3 Terms and definitions 11 4 General recommendations . 15 4.1 Concurrent and sequential testing . 15 4.2 General test conditions 15 4.2.1 Configurations

8、 . 15 4.2.2 Artificial hand . 15 4.2.3 Power input voltages and frequencies . 16 5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents 17 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the connector testing exemption specified in 8.13.2 c) is used . 17 5.2 A

9、CCOMPANYING DOCUMENTS 17 5.2.1 General . 17 5.2.2 Instructions for use 17 5.2.3 Requirements applicable to ME EQUIPMENT and ME SYSTEMS for which the connector testing exemption specified in 8.13.2 c) is used . 17 5.2.4 * Technical description . 17 6 Documentation of the tests 18 6.1 Test plan . 18 6

10、.2 Test report 19 7 * EMISSIONS . 19 8 IMMUNITY recommendations 19 8.1 General . 19 8.2 PATIENT physiological simulation 20 8.3 Termination of PATIENT-COUPLED parts . 21 8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD . 21 8.5 Subsystems 21 8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT

11、and LARGE ME SYSTEMS . 21 8.7 Operating modes . 22 8.8 Non-ME EQUIPMENT 22 8.9 * Environments of INTENDED USE 22 8.10 * Performance criteria . 23 8.11 * IMMUNITY TEST LEVELS 23 8.12 * IMMUNITY to proximity fields from RF wireless communications equipment 30 8.13 * ESD testing of connectors . 31 8.13

12、.1 Application of ESD to connectors . 31 8.13.2 Exclusions . 32 PD IEC/TR 60601-4-2:2016IEC TR 60601-4-2:2016 IEC 2016 3 9 Test report. 33 Annex A (informative) General guidance and rationale 35 Annex B (informative) Guide to labelling recommendations . 40 B.1 ACCOMPANYING DOCUMENTS, instructions fo

13、r use . 40 B.2 ACCOMPANYING DOCUMENTS, technical description . 40 Annex C (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS 41 C.1 General . 41 C.2 EM DISTURBANCE level determination . 42 C.3 Assessment of EM DISTURBANCE sources 42 C.4 Test methods 42 C.5 Test plan . 42 C.

14、6 Examples of mitigations and special conditions 43 Annex D (informative) Identification of specific IMMUNITY performance criteria . 44 D.1 General . 44 D.2 IMMUNITY performance criteria principles 44 D.2.1 General . 44 D.2.2 IMMUNITY performance criteria for non-ME EQUIPMENT used in an ME SYSTEM .

15、44 D.2.3 IMMUNITY performance criteria determination . 44 D.3 IMMUNITY performance criteria examples 44 D.3.1 General examples 44 D.3.2 Example of immunity performance criteria for a radiological table system . 46 D.3.3 Example of immunity performance criteria for ultrasonic diagnostic equipment 46

16、Annex E (informative) Performance criteria specified by IEC 61000-6-x generic EMC standards . 48 Annex F (informative) Mapping between this document and the elements of IEC 60601-1-2:2014 49 Bibliography . 54 Index of defined terms used in this technical report . 56 Figure 1 RC element of the artifi

17、cial hand . 16 Figure 2 * PORTS of ME EQUIPMENT and ME SYSTEMS . 20 Figure 3 Examples of environments (locations) of INTENDED USE 25 Table 1 Recommended minimum test plan (1 of 2) 18 Table 2 * ENCLOSURE PORT . 26 Table 3 * Input AC power PORT (1 of 2) . 26 Table 4 Input DC power PORT . 28 Table 5 *

18、PATIENT COUPLING PORT . 29 Table 6 SIGNAL INPUT/OUTPUT PARTS PORT . 30 Table 7 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment . 31 Table 8 Parts of connectors to be tested for ESD, based on the connector shell and cover material . 32 Table 9 * Testing of conn

19、ectors and pins while connected and disconnected . 32 PD IEC/TR 60601-4-2:2016 4 IEC TR 60601-4-2:2016 IEC 2016 Table 10 Test report minimum contents (1 of 2) 33 Table A.1 Assumptions used in determining IMMUNITY TEST LEVELS specified in Table 7 (1 of 2) . 38 Table B.1 ACCOMPANYING DOCUMENTS, instru

20、ctions for use 40 Table B.2 ACCOMPANYING DOCUMENTS, technical description 40 Table C.1 Examples of adjusted IMMUNITY TEST LEVELS due to mitigations or special conditions . 43 Table D.1 Example of IMMUNITY performance criteria for a radiological table and gantry system . 46 Table D.2 Example of IMMUN

21、ITY performance criteria for ULTRASONIC DIAGNOSTIC EQUIPMENT 47 Table F.1 Mapping between the elements of IEC TR 60601-4-2 and IEC 60601-1-2:2014 (1 of 5) 49 PD IEC/TR 60601-4-2:2016IEC TR 60601-4-2:2016 IEC 2016 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 4-2: Gu

22、idance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC Nati

23、onal 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, Technical Reports, Publi

24、cly 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 and non-governm

25、ental 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 agreements of IEC on

26、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 and are accepted

27、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 u

28、niformity, 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.

29、 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) All users should e

30、nsure 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 or other damage o

31、f 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 publication. Use of the

32、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. T

33、he main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of th

34、e art“. IEC 60601-4-2, which is a technical report, has been prepared by IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. PD IEC/TR 60601-4-2:2016 6 IEC TR 60601-4-2:2016 IEC 2016 The text

35、of this technical report is based on the following documents: Enquiry draft Report on voting 62A/1068/DTR 62A/1073A/RVCFull information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in acco

36、rdance with the ISO/IEC Directives, Part 2. In this technical report, the following print types are used: Recommendations and definitions: roman type. Test instructions: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative

37、text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THIS TECHNICAL REPORT OR AS NOTED: SMALL CAPITALS. In referring to the structure of this technical report, the term “clause” means one of the numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Cl

38、ause 1 includes 1.1, 1.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 1.1, 1.2 and 1.3.1 are all subclauses of Clause 1). References to clauses within this technical report are preceded by the term “Clause” followed by the clause number. References to subclauses within this tec

39、hnical report are by number only. In this technical report, the 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 technical report conform to usage described in Annex H of the ISO/IEC Directives, Part 2. F

40、or the purposes of this technical report, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this technical report; however, we chose to use it in this technical report only as described in 0.3; “should” means that compliance with a requir

41、ement or a test is recommended but is not mandatory for compliance with this technical report; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates t

42、hat there is guidance or rationale related to that item in Annex A. A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged unti

43、l the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be g120 reconfirmed, g120 withdrawn, g120 replaced by a revised edition, or PD IEC/TR 60601-4-2:2016IEC TR 60601-4-2:2016 IEC 2016 7 g12

44、0 amended. A bilingual version of this publication may be issued at a later date. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print th

45、is document using a colour printer. PD IEC/TR 60601-4-2:2016 8 IEC TR 60601-4-2:2016 IEC 2016 INTRODUCTION 0.1 * General MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS are used in the practice of medicine because they provide needed functions that are associated with the INTENDED USE. I

46、f MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM does not provide these needed functions because of a lack of IMMUNITY to ELECTROMAGNETIC DISTURBANCES that are expected to occur in the environment(s) of INTENDED USE, this can interfere with the practice of medicine. This document provid

47、es guidance on assessing IMMUNITY, with regard to the INTENDED USE. Based on the INTENDED USE, MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS should have adequate IMMUNITY to provide the performance specified by the MANUFACTURER in the presence of ELECTROMAGNETIC DISTURBANCES. See Annex

48、 A for more information regarding performance. Guidance for IMMUNITY with regard to INTENDED USE can be useful for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for which the BASIC SAFETY AND ESSENTIAL PERFORMANCE do not include the purpose(s) for which the ME EQUIPMENT or ME SYSTEM wa

49、s purchased. It is important to the OPERATOR or RESPONSIBLE ORGANIZATION and to the delivery of healthcare that these functions operate as intended in the EM ENVIRONMENTS of INTENDED USE. Examples of performance that might not be BASIC SAFETY or ESSENTIAL PERFORMANCE but that might be INTENDED USE include the following: the ability to print an ultrasound image remotely; the ability of a scale to accurately measure PATIENT weight; accuracy of X-RAY TUBE V