1、Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems PD IEC/TR 60601-4-2:2016 BSI Standards PublicationNational foreword This Published Document is the UK implementation of IEC/TR 60601
2、-4-2:2016. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice. A list of organizations represented on this committee can be obtained on
3、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 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 88577 8 ICS 11.040.01; 33.100.20 Compli
4、ance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 60601-4-
5、2:2016 IEC TR 60601-4-2 Edition 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
6、 978-2-8322-3414-3 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colour inside PD IEC/TR 60601-4-2:2016 2 IEC TR 60601-4-2:2016 IEC 2016 CONTENTS FOREWORD . 5 INTRODUCTION . 8 0.1 * General
7、8 0.2 Purpose of this document 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 conditi
8、ons 15 4.2.1 Configurations . 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
9、.13.2 c) is used . 17 5.2 ACCOMPANYING 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 te
10、sts 18 6.1 Test plan . 18 6.2 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 IN
11、STALLED LARGE ME EQUIPMENT 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 test
12、ing of connectors . 31 8.13.1 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
13、 DOCUMENTS, instructions for 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 metho
14、ds 42 C.5 Test plan . 42 C.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 EQUIPM
15、ENT used in an ME SYSTEM . 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 ultrason
16、ic diagnostic equipment 46 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
17、 1 RC element of the artificial 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
18、 power PORT . 28 Table 5 * 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 . 3
19、2 Table 9 * Testing of connectors 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 ACC
20、OMPANYING DOCUMENTS, instructions 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
21、 Table D.2 Example of IMMUNITY 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 ELECT
22、RICAL EQUIPMENT Part 4-2: Guidance 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 electrote
23、chnical committees (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 Specificatio
24、ns, Technical 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,
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26、ions or agreements 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 intern
27、ational use 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 ord
28、er to promote 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 cle
29、arly indicated 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
30、bodies. 6) All 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, prop
31、erty damage 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
32、this publication. 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
33、 or all such patent rights. The 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 Stand
34、ard, for example “state of the 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 6060
35、1-4-2:2016 IEC 2016 The text of this technical report is based on the following documents: Enquiry draft Report on voting 62A/1068/DTR 62A/1073A/RVC Full 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 public
36、ation has been drafted in accordance 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 reference
37、s: in smaller type. Normative 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, inclusiv
38、e of all subdivisions (e.g. Clause 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
39、 to subclauses within this technical 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
40、 ISO/IEC Directives, Part 2. For 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
41、 that compliance with a requirement 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 paragr
42、aph or table title indicates that 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 publicat
43、ion will remain unchanged until 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 reconfirmed, withdrawn, replaced by a revised edition, or PD IEC/TR 60601-4-2:2016IEC TR 60601-4-2:2016
44、 IEC 2016 7 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 therefor
45、e print this 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 INTEN
46、DED USE. If 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 docum
47、ent provides 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.
48、 See Annex 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
49、 SYSTEM was 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; accur
