IEC 60601-2-33:2010
(Main)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. 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 been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate. The contents of the corrigenda of March 2012 and February 2016 have been included in this copy.
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
La CEI 60601-2-33:2010 établit des exigences particulières relatives à la sécurité de base et aux performances essentielles pour les appareils à résonance magnétique en matière de protection pour le patient et le personnel pour la résonance magnétique. Cette troisième édition annule et remplace la deuxième édition parue en 2002, son Amendement 1 (2005) et son Amendement 2 (2007), et constitue une révision technique. Cette troisième édition de la CEI 60601-2-33 est basée sur le deuxième amendement de l'Edition 2. Elle a également été adaptée à la troisième édition de la CEI 60601-1 (2005), des modifications techniques ayant été introduites le cas échéant. Le contenu du corrigendum de mars 2012 et février 2016 a été pris en considération dans cet exemplaire.
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IEC 60601-2-33 ®
Edition 3.0 2010-03
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
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IEC 60601-2-33 ®
Edition 3.0 2010-03
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
PRICE CODE
INTERNATIONALE
XE
CODE PRIX
ICS 11.040.55 ISBN 978-2-88910-221-1
– 2 – 60601-2-33 © IEC:2010
CONTENTS
FOREWORD.54
INTRODUCTION.6H6H7
201.1 Scope, object and related standards .7H7H8
201.2 Normative references.8H8H9
201.3 Terms and definitions.9H9H10
201.4 General requirements .10H10H15
201.5 General requirements for testing 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 SYSTEMS.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 fault 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 .24H24H48
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 .30H30H11
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 B stray field .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
EQUIPMENT.37H37H83
BODY MR
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-θ).39H39H88
Figure AA.5 – Gradient waveform 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 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 summation of the maximum output O per
i
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
Table 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 International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical 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 Specifications,
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, governmental and non-
governmental 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 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 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 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 clearly 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 mark
...
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
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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
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.
Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
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Restez informé sur les nouvelles publications de la CEI.
Just Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur
Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: csc@iec.ch.
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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical 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 Specifications,
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, governmental and non-
governmental 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 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 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 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 reg
...
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.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
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
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
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details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
15 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
La recherche avancée permet de trouver des publications IEC Plus de 60 000 entrées terminologiques électrotechniques, en
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des
CE 37, 77, 86 et CISPR de l'IEC.
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Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
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 .
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