IEC 60601-2-33:2022

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

• Status: Published
• Publication Date: 03-Aug-2022
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 40 - TC 62/SC 62B/MT 40
• Current Stage: PPUB - Publication issued
• Start Date: 29-Jul-2022
• Completion Date: 04-Aug-2022

Relations

• Revises: IEC 60601-2-33:2010/COR2:2016 - Corrigendum 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-33:2022/ISH1:2023 - Interpretation Sheet 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-33:2010/COR1:2012 - Corrigendum 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-33:2010/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-33:2010/AMD2:2015 - Amendment 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-33:2010 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 05-Sep-2023

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
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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
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all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
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