IEC 60601-2-33:2022
(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 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
IEC 60601-2-33:2022 cancels and replaces the third edition published in 2010, Amendment 1:2013 and Amendment 2:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) aligned with IEC 60601-1:2005 and its two amendments IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) addition of safety requirements for the EMERGENCY FIELD SHUT DOWN UNIT;
c) clarification of acoustic protection measures for the PATIENT and MR WORKER;
d) addition of noise emission declaration for exposure inside the MR EXAMINATION ROOM, to support occupational health assessment by the RESPONSIBLE ORGANIZATION;
e) addition of compliance methods for thermal safety of RF coils;
f) addition of RF transmit definitions to match MR CONDITIONAL labelling requirements for MEDICAL DEVICES;
g) clarification of requirements for MR CONDITIONAL labelling of ACCESSORIES;
h) alignment of static magnetic field limit for B0 HAZARD area to limits in other MEDICAL DEVICE standards (especially that for pacemakers, ISO 14117), the new limit value being 0,9 mT;
i) improved description of the magnetic field related plots in the Compatibility Technical Specification Sheet (CTSS);
j) provision of compatibility sequences (in the CTSS) to test auxiliary equipment by the MR manufacturer has become optional, and is expected to be eliminated in a future edition;
k) a separate section with requirements for a site-planning document containing safety information;
l) requirements for the alerting function (PATIENT to OPERATOR);
m) introduction of MROC as mandatory functionality for 1,5 T and 3 T systems to facilitate scanning of PATIENTs with MEDICAL DEVICES labelled as MR CONDITIONAL, unless such scanning is explicitly contra-indicated by the MR MANUFACTURER;
n) RF coil symbols in Table 201.A.102 have become mandatory, and the preferred and alternate signs have been swapped relative to the previous edition, with preferred now being the sign with color;
o) determination of the B1 stray field in 201.12.4.105.3.3 based on calculations only
The contents of the Interpretation Sheet 1 of May 2023 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
L'IEC 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
L'IEC 60601-2-33:2022 annule et remplace la troisième édition parue en 2010, l’Amendement 1:2013 et l’Amendement 2:2015. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente:
a) alignement sur l’IEC 60601-1:2005 et ses deux amendements IEC 60601 1:2005/AMD1:2012 et IEC 60601-1:2005/AMD2:2020;
b) ajout d’exigences de sécurité pour l'UNITE DE COUPURE D’URGENCE DU CHAMP;
c) clarification des mesures de protection acoustique pour le PATIENT et le PERSONNEL RM;
d) ajout d’une déclaration d'émission de bruit pour l’exposition à l'intérieur de la SALLE D’EXAMEN PAR RM, afin de soutenir l'évaluation de la santé au travail par L’ORGANISME RESPONSABLE;
e) ajout de méthodes de conformité pour la sécurité thermique des bobines RF;
f) ajout de définitions d’émission RF pour satisfaire aux exigences applicables à l’étiquetage à RM CONDITIONNELLE des DISPOSITIFS MEDICAUX;
g) clarification des exigences applicables à l’étiquetage à RM CONDITIONNELLE des ACCESSOIRES;
h) alignement de la limite de champ magnétique statique pour la zone de DANGER B0 sur les limites dans les autres normes de DISPOSITIFS MEDICAUX (notamment la limite pour les stimulateurs cardiaques, ISO 14117), avec une nouvelle valeur limite de 0,9 mT;
i) meilleure description des tracés relatifs aux champs magnétiques sur la fiche de spécifications techniques de compatibilité (CTSS);
j) la fourniture de séquences de compatibilité (sur la CTSS) pour l’essai de l'appareil auxiliaire par le FABRICANT RM est désormais facultative, et sa suppression est prévue dans une édition future;
k) présence d’une section distincte qui comporte les exigences relatives à un document d’aménagement du site contenant des informations de sécurité;
l) exigences pour la fonction d’avertissement (de PATIENT à OPERATEUR);
m) introduction de la fonctionnalité MROC obligatoire pour les systèmes 1,5 T et 3 T afin de faciliter le balayage des PATIENTs qui portent des DISPOSITIFS MEDICAUX étiquetés comme équipements à RM CONDITIONNELLE, à moins que ce balayage ne fasse l'objet d’une contre-indication explicite du FABRICANT RM;
n) les symboles pour bobines RF dans le Tableau 201.A.102 sont devenus obligatoires, et les signaux variants préférentiels ont été échangés par rapport à l’édition précédente, le signal avec couleur constituant désormais le signal préférentiel;
o) la détermination du champ parasite B1 en 201.12.4.105.3.3 uniquement par des calculs.
General Information
Relations
Standards Content (Sample)
IEC 60601-2-33 ®
Edition 4.0 2022-08
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 Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@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.
Recherche de publications IEC - Découvrez notre puissant moteur de recherche et consultez
webstore.iec.ch/advsearchform gratuitement tous les aperçus des publications. Avec un
La recherche avancée permet de trouver des publications IEC abonnement, vous aurez toujours accès à un contenu à jour
en utilisant différents critères (numéro de référence, texte, adapté à vos besoins.
comité d’études, …). Elle donne aussi des informations sur les
projets et les publications remplacées ou retirées. Electropedia - www.electropedia.org
Le premier dictionnaire d'électrotechnologie en ligne au monde,
IEC Just Published - webstore.iec.ch/justpublished
avec plus de 22 300 articles terminologiques en anglais et en
Restez informé sur les nouvelles publications IEC. Just
français, ainsi que les termes équivalents dans 19 langues
Published détaille les nouvelles publications parues.
additionnelles. Egalement appelé Vocabulaire
Disponible en ligne et une fois par mois par email.
Electrotechnique International (IEV) en ligne.
Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
IEC Products & Services Portal - products.iec.ch
IEC 60601-2-33 ®
Edition 4.0 2022-08
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 978-2-8322-3955-1
– 2 – IEC 60601-2-33:2022 © IEC 2022
CONTENTS
FOREWORD . 4
* INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
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 . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 36
201.9 Protection against MECHANICAL HAZARDs of ME EQUIPMENT and ME SYSTEMS . 37
201.10 Protection against unwanted and excessive radiation HAZARDS . 39
201.11 Protection against excessive temperatures and other HAZARDS . 39
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 39
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 60
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) . 61
201.15 Construction of ME EQUIPMENT . 61
201.16 ME SYSTEMS . 61
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 62
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 62
Annexes . 65
Annex A (informative) Symbols on marking . 66
Annex AA (informative) Particular guidance and rationale . 70
Bibliography . 130
Index of defined terms used in this document . 142
Figure 201.101 – Gradient waveform and EFFECTIVE STIMULUS DURATION . 13
Figure 201.102 – Limits for cardiac and peripheral nerve stimulation . 44
Figure 201.103 – Applicable WHOLE BODY SAR limit values in FIRST LEVEL CONTROLLED
OPERATING MODE as function of AMBIENT TEMPERATURE . 47
Figure 201.104 – Volume for determining the spatial maximum of GRADIENT OUTPUT . 54
Figure 201.105 – Volume for determining the B stray field. 56
Figure AA.1 – SAR limits for the exposed mass of a PATIENT . 76
Figure AA.2 – Static magnetic fields: flow potentials and retardation . 93
Figure AA.3 – Bulls eye view for SFG at multiple equidistant cylinders . 105
Figure AA.4 – Experimental data on PNS THRESHOLD LEVEL of human volunteers in
WHOLE BODY GRADIENT SYSTEM . 114
Figure AA.5 – Double logarithmic plot of experimental threshold values for peripheral
nerve stimulation . 115
Figure AA.6 – Response value R(t) generated by convolution of a rectangular
stimulus dB/dt and a nerve impulse response function n(t-θ) . 120
Figure AA.7 – Gradient waveform G, stimulus waveform dB/dt and response value R,
for a trapezoid EPI waveform starting at t = 0 . 120
Figure AA.8 – Threshold values dB/dt for two gradient waveforms, plotted against
EFFECTIVE STIMULUS DURATION . 121
Figure AA.9 – Threshold value of dB/dt for a sinusoid gradient waveform, as function of
the number of half periods in the waveform . 121
Figure AA.10 – Schematic overview of various possible hardware configurations of a
birdcage coil and their appropriate classification . 126
Table 201.101 – Units outside the SI units system that may be used on MR EQUIPMENT . 20
Table 201.102 – Rheobase values per type of gradient system . 43
Table 201.103 – Weighting factors for PNS evaluation per GRADIENT UNIT . 45
Table 201.104 – SAR limits for VOLUME RF TRANSMIT COILS . 46
Table 201.105 – SAR limits for LOCAL RF TRANSMIT COILs . 46
+
Table 201.106 – Maximum B PEAK values for MROC implementation . 58
Table 201.107 – User selectable control parameters for MROC implementation . 59
Table 201.A.101 – MR SAFETY SIGNs . 66
Table 201.A.102 – RF coil symbols . 68
Table 201.A.103 – MR CONDITIONAL symbols . 69
Table 201.AA.101 – Overview of quantities, and their SI units . 80
Table 201.AA.102 – Overview physiological effects in humans, animals and model
systems, for magnetic-field exposures at field strengths relevant for MRI . 83
Table 201.AA.103 – CORE TEMPERATURE limits . 122
– 4 – IEC 60601-2-33:2022 © IEC 2022
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 in
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.