IEC 60601-2-33:2010

IEC 60601-2-33 ®
Edition 3.1 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-33: Particular requirements for the basic safety and essential performance
of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à résonance magnétique utilisés pour le diagnostic
médical
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IEC 60601-2-33 ®
Edition 3.1 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential performance

of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à résonance magnétique utilisés pour le diagnostic

médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-0783-3

– 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

201.4 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 mechanical 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 SITUATIONS 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 . 50
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 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 B stray field . 48
Figure 201.D.101 – Signs indicating a transmit only RF coil, transmit / 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 experimental 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-θ) . 90

Figure AA.5 – Gradient waveform G, stimulus waveform dB/dt and response value R,

for a trapezoid EPI waveform 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 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 O per
i
GRADIENT UNIT . 36
Table 201.104 – Temperature limits . 36
Table 201.105 – SAR limits for volume transmit 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: Particular requirements for the basic safety and essential

performance of magnetic resonance equipment for medical diagnosis

FOREWORD
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...

IEC 60601-2-33 ®
Edition 3.2 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-33: Particular requirements for the basic safety and essential performance
of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à résonance magnétique utilisés pour le diagnostic
médical
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from

either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or

your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

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CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
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iPad. Electrotechnical Vocabulary (IEV) online.

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and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

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IEC 60601-2-33 ®
Edition 3.2 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential

performance
of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les

performances
essentielles des appareils à résonance magnétique utilisés pour le diagnostic

médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-2743-5

IEC 60601-2-33 ®
Edition 3.2 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-33: Particular requirements for the basic safety and essential performance
of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à résonance magnétique utilisés pour le diagnostic
médical
– 2 – IEC 60601-2-33:2010
+AMD1:2013+AMD2:2015 CSV  IEC 2015

CONTENTS
FOREWORD . 4

* INTRODUCTION . 7

INTRODUCTION TO AMENDMENT 1 . 8

INTRODUCTION TO AMENDMENT 2 . 8

201.1 Scope, object and related standards . 9

201.2 Normative references . 10

201.3 Terms and definitions . 11
201.4 General requirements . 18
201.5 General requirements for testing of ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 32
201.9 Protection against mechanical HAZARDs of ME EQUIPMENT and ME SYSTEMS . 32
201.10 Protection against unwanted and excessive radiation HAZARDS . 33
201.11 Protection against excessive temperatures and other HAZARDS . 33
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 33
201.13 HAZARDOUS SITUATIONS and fault conditions . 54
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) . 54
201.15 Construction of ME EQUIPMENT . 54
201.16 ME SYSTEMS . 54
* 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 55
* 202 Electromagnetic compatibility – Requirements and tests. 55
Annexes . 57
Annex D (informative) Symbols on marking . 58
Annex AA (informative) Particular guidance and rationale . 62
Bibliography . 119
Index of defined terms used in this particular standard . 131

Figure 201.101 – Gradient waveform and EFFECTIVE STIMULUS DURATION . 12
Figure 201.102 – Limits for cardiac and peripheral nerve stimulation . 38
Figure 201.103 – Reduction of WHOLE BODY SAR limits at high temperatures . 42
Figure 201.104 – Volume for determining the spatial maximum of gradient output . 48
Figure 201.105 – Volume for determining the B stray field . 51
Figure 201.D.101 – Signs indicating a transmit only RF coil, transmit / receive RF coil
and a receive only coil  .
Figure AA.1 – Static magnetic fields: flow potentials and retardation . 88
Figure AA.2 – Experimental data on PNS threshold of human volunteers in WHOLE
BODY MR EQUIPMENT . 104
Figure AA.3 – Double logarithmic plot of experimental threshold values for peripheral
nerve stimulation . 105
Figure AA.4 – Response value R(t) generated by convolution of a rectangular
stimulus dB/dt and a nerve impulse response function n(t-θ) . 109

+AMD1:2013+AMD2:2015 CSV  IEC 2015

Figure AA.5 – Gradient waveform G, stimulus waveform dB/dt and response value R,

for a trapezoid EPI waveform starting at t = 0 . 110

Figure AA.6 – Threshold values dB/dt for two gradient waveforms, plotted against

EFFECTIVE STIMULUS DURATION . 110

Figure AA.7 – Threshold value of dB/dt for a sinusoid gradient waveform, as function
of the number of half periods in the waveform . 111

Figure AA.8 – SAR limits for the exposed mass of a PATIENT . 114

Table 201.101 – List of symbols and abbreviations . 17

Table 201.102 – Rheobase values per type of gradient system . 37
Table 201.103 – Weight factors for summation of the maximum output O per
i
GRADIENT UNIT . 39
Table 201.104 – Temperature limits . 39
Table 201.105 – SAR limits for volume transmit coils . 40
Table 201.106 – SAR limits for local transmit coils . 41
Table 201.107 – FPO limits applicable for cylindrical MR SYSTEMS . 52
Table 201.D.101 – Example of warning signs and prohibitive signs MR SAFETY SIGNS . 58
Table 201.D.102 – RF coil symbols . 60
Table 201.D.103 – MR conditional symbols . 61
Table AA.1 – Static field occupational standards .
...