1、 IEC 60601-2-33Edition 3.0 2010-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical 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 particulire
2、s pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdical IEC60601-2-33:2010 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2010 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this
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17、E INTERNATIONALEMedical 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 particulires pour la scurit de base et les performances essentielles des
18、 appareils rsonance magntique utiliss pour le diagnostic mdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XEICS 11.040.55 PRICE CODECODE PRIXISBN 2-8318-1081-8 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commissi
19、on Electrotechnique Internationale colourinside 2 60601-2-33 IEC:2010 CONTENTS FOREWORD.54 INTRODUCTION.6H6H7 201.1 Scope, object and related standards .7H7H8 201.2 Normative references8H8H9 201.3 Terms and definitions 9H9H10 201.4 General requirements . 10H10H15 201.5 General requirements for testi
20、ng of ME EQUIPMENT 11H11H15 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12H12H15 201.7 ME EQUIPMENT identification, marking and documents . 13H13H16 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14H14H27 201.9 Protection against mechanical HAZARDs of ME EQUIPMENT and ME SYS
21、TEMS 15H15H28 201.10 Protection against unwanted and excessive radiation HAZARDS . 16H16H28 201.11 Protection against excessive temperatures and other HAZARDS . 17H17H28 201.12 Accuracy of controls and instruments and protection against hazardous outputs .18H18H29 201.13 HAZARDOUS SITUATIONS and fau
22、lt conditions 19H19H47 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS). 20H20H47 201.15 Construction of ME EQUIPMENT. 21H21H47 201.16 ME SYSTEMS 22H22H47 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23H23H47 202 Electromagnetic compatibility Requirements and tests . 24H
23、24H48 Annexes . 25H25H48 Annex D (informative) Symbols on marking 26H26H49 Annex AA (informative) Particular guidance and rationale 27H27H51 Bibliography 28H28H96 Index of defined terms used in this particular standard 29H29H104 Figure 201.101 Gradient waveform and EFFECTIVE STIMULUS DURATION . 30H3
24、0H11 Figure 201.102 Limits for cardiac and peripheral nerve stimulation 31H31H33 Figure 201.103 Reduction of WHOLE BODY SAR limits at high temperatures 32H32H37 Figure 201.104 Volume for determining the spatial maximum of gradient output 33H33H43 Figure 201.105 Volume for determining the B1stray fie
25、ld 34H34H46 Figure 201.D.101 Signs indicating a transmit only RF coil, transmit / receive RF coil and a receive only RF coil. 35H35H50 Figure AA.1 Static magnetic fields: flow potentials and retardation. 36H36H68 Figure AA.2 Experimental data on PNS threshold of human volunteers in WHOLE BODY MR EQU
26、IPMENT. 37H37H83 Figure AA.3 Double logarithmic plot of experimental threshold values for peripheral nerve stimulation 38H38H84 Figure AA.4 Response value R(t) generated by convolution of a rectangular stimulus dB/dt and a nerve impulse response function n(t-). 39H39H88 Figure AA.5 Gradient waveform
27、 G, stimulus waveform dB/dt and response value R, for a trapezoid EPI waveform starting at t = 0 . 40H40H89 60601-2-33 IEC:2010 3 Figure AA.6 Threshold values dB/dt for two gradient waveforms, plotted against EFFECTIVE STIMULUS DURATION . 41H41H89 Figure AA.7 Threshold value of dB/dt for a sinusoid
28、gradient waveform, as function of the number of half periods in the waveform. 42H42H90 Figure AA.8 SAR limits for the exposed mass of a PATIENT 43H43H93 Table 201.101 List of symbols 44H44H15 Table 201.102 Rheobase values per type of gradient system. 45H45H32 Table 201.103 Weight factors for summati
29、on of the maximum output Oiper GRADIENT UNIT .46H46H34 Table 201.104 Temperature limits 47H47H34 Table 201.105 SAR limits for volume transmit coils . 48H48H35 Table 201.106 SAR limits for local transmit coils . 49H49H36 Table 201.D.101 Examples of warning signs and prohibitive signs):. 50H50H49 Tabl
30、e AA.1 Static field occupational standards. 51H51H67 4 60601-2-33 IEC:2010 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis FOREWORD 1) The
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41、 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 60601-2-33 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: El
42、ectrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also be
43、en adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate. 60601-2-33 IEC:2010 5 The text of this particular standard is based on the following documents: FDIS Report on voting 62B/777/FDIS 62B/782/RVDFull information on the voting for the
44、 approval of this particular standard can be found in the report on voting indicated in the above table. 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 specifica
45、tions: italic type. Informative 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
46、to the structure of this 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 sub
47、clauses of Clause 7). 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
48、 any combination of the 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 wi
49、th this standard; “should” 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 guid
