IEC 60601-2-33 Edition 3.1-2013 Medical electrical equipment - Part 2-33 Particular requirements for the basic safety and essential performance of magnetic reso.pdf

1、 IEC 60601-2-33 Edition 3.1 2013-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis Appareils lectromdicaux Partie 2-33: Exigences particul

2、ires pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdical IEC60601-2-33:2010+A1:2013 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no p

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16、ez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-33 Edition 3.1 2013-04 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance

17、 of magnetic resonance equipment for medical diagnosis Appareils lectromdicaux Partie 2-33: Exigences particulires pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTE

18、CHNIQUE INTERNATIONALE ICS 11.040.55 ISBN 978-2-8322-0783-3 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vo

19、us assurer que vous avez obtenu cette publication via un distributeur agr. colourinside 2 60601-2-33 IEC:2010+A1:2013 CONTENTS FOREWORD . 4 INTRODUCTION . 7 INTRODUCTION TO AMENDMENT 1 . 8 201.1 Scope, object and related standards . 9 201.2 Normative references 10 201.3 Terms and definitions 11 201.

20、4 General requirements . 16 201.5 General requirements for testing of ME EQUIPMENT 16 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 17 201.7 ME EQUIPMENT identification, marking and documents . 17 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 29 201.9 Protection against mecha

21、nical HAZARDs of ME EQUIPMENT and ME SYSTEMS 29 201.10 Protection against unwanted and excessive radiation HAZARDS . 30 201.11 Protection against excessive temperatures and other HAZARDS . 30 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 30 201.13 HAZARDOUS S

22、ITUATIONS and fault conditions 49 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) . 49 201.15 Construction of ME EQUIPMENT . 49 201.16 ME SYSTEMS 49 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 49 202 Electromagnetic compatibility Requirements and tests . 50 Annexes . 5

23、0 Annex D (informative) Symbols on marking 51 Annex AA (informative) Particular guidance and rationale 53 Bibliography 98 Index of defined terms used in this particular standard 106 Figure 201.101 Gradient waveform and EFFECTIVE STIMULUS DURATION . 12 Figure 201.102 Limits for cardiac and peripheral

24、 nerve stimulation 35 Figure 201.103 Reduction of WHOLE BODY SAR limits at high temperatures 39 Figure 201.104 Volume for determining the spatial maximum of gradient output 45 Figure 201.105 Volume for determining the B1stray field 48 Figure 201.D.101 Signs indicating a transmit only RF coil, transm

25、it / receive RF coil and a receive only RF coil . 52 Figure AA.1 Static magnetic fields: flow potentials and retardation . 70 60601-2-33 IEC:2010+A1:2013 3 Figure AA.2 Experimental data on PNS threshold of human volunteers in WHOLE BODY MR EQUIPMENT. 85 Figure AA.3 Double logarithmic plot of experim

26、ental threshold values for peripheral nerve stimulation 86 Figure AA.4 Response value R(t) generated by convolution of a rectangular stimulus dB/dt and a nerve impulse response function n(t-) . 90 Figure AA.5 Gradient waveform G, stimulus waveform dB/dt and response value R, for a trapezoid EPI wave

27、form starting at t = 0 . 91 Figure AA.6 Threshold values dB/dt for two gradient waveforms, plotted against EFFECTIVE STIMULUS DURATION . 91 Figure AA.7 Threshold value of dB/dt for a sinusoid gradient waveform, as function of the number of half periods in the waveform . 92 Figure AA.8 SAR limits for

28、 the exposed mass of a PATIENT 95 Table 201.101 List of symbols 16 Table 201.102 Rheobase values per type of gradient system . 34 Table 201.103 Weight factors for summation of the maximum output Oiper GRADIENT UNIT . 36 Table 201.104 Temperature limits 36 Table 201.105 SAR limits for volume transmit

29、 coils . 37 Table 201.106 SAR limits for local transmit coils . 38 Table 201.D.101 Examples of warning signs and prohibitive signs . 51 Table AA.1 Static field occupational standards . 69 4 60601-2-33 IEC:2010+A1:2013 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-33

30、: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC Nati

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41、his consolidated version of IEC 60601-2-33 consists of the third edition (2010) documents 62B/777/FDIS and 62B/782/RVD, its corrigendum 1 of March 2012 and its amendment 1 (2013) documents 62B/884/CDV and 62B/904/RVC. It bears the edition number 3.1. The technical content is therefore identical to t

42、he base edition and its amendment and has been prepared for user convenience. A vertical line in the margin shows where the base publication has been modified by amendment 1. Additions and deletions are displayed in red, with deletions being struck through. 60601-2-33 IEC:2010+A1:2013 5 Internationa

43、l standard IEC 60601-2-33 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of I

44、EC 60601-1 (2005), with technical modifications being introduced where appropriate. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. I

45、nformative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of t

46、his standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7).

47、 References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of t

48、he conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “sh

49、ould” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “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 that there is guidance or rationale related to that item i