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

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
Current Stage
PPUB - Publication issued
Completion Date
04-Aug-2022
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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
IEC 60601-2-33:2022-08(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 60601-2-33:2022 © IEC 2022 – 3 –
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

---------------------- Page: 5 ----------------------
– 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,

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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

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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

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any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of 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.

IEC 60601-2-33 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of

IEC technical committee 62: Electrical equipment in medical practice. It is an International

Standard.

This fourth edition 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;
---------------------- Page: 6 ----------------------
IEC 60601-2-33:2022 © IEC 2022 – 5 –
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 B 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 B stray field in 201.12.4.105.3.3 based on calculations only.

The text of this International Standard is based on the following documents:
Draft Report on voting
62B/1277/FDIS 62B/1284/RVD

Full information on the voting for its approval can be found in the report on voting indicated in

the above table.
The language used for the development of this International Standard is English.

This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in

accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available

at http://www.iec.ch/members_experts/refdocs. The main document types developed by IEC

are described in greater detail at www.iec.ch/standardsdev/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term

– "clause" means one of the eighteen 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

subclauses of Clause 7).

References to clauses within this document are preceded by the term "Clause" followed by the

clause number. References to subclauses within this document are by number only.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-33:2022 © IEC 2022

In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC

Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance with

this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "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 guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title:

Medical electrical equipment, can be found on the IEC website.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under webstore.iec.ch/?ref=menu in the data related

to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates that it

contains colours which are considered to be useful for the correct understanding of its

contents. Users should therefore print this document using a colour printer.
---------------------- Page: 8 ----------------------
IEC 60601-2-33:2022 © IEC 2022 – 7 –
* INTRODUCTION

This International Standard addresses technical aspects of medical diagnostic MR EQUIPMENT

and MR SYSTEMS, necessary to ensure the safety of PATIENTs, and to address electromagnetic

field (EMF) exposure concerns for MR WORKERs involved with the operation, development,

manufacturing, installation, and servicing of MR EQUIPMENT and MR SYSTEMS. Annex AA provides

rationales for requirements and limit values including references to peer-reviewed publications

used to establish the content of this document.

Exposure limits for PATIENTs and for MR WORKERs are selected to protect them from transient

adverse health effects and from unacceptable RISK. In addition, scientific consensus today is

that no experimental or theoretical basis exists to expect long-term adverse health effects in

humans from (repeated) EMF exposures.

Organizational aspects related to safety of operating the MR EQUIPMENT are the task of the

RESPONSIBLE ORGANIZATION. This task includes, but is not limited to:
– qualification of staff for decisions that are related to safety;
– adequate training of staff;
– definition of medical responsibility; including

• rules for screening the PATIENT for contraindications or for conditions that can affect

acceptable exposure;

• rules for ROUTINE MONITORING, and for MEDICAL SUPERVISION of the PATIENT during the MR

EXAMINATION;

• rules for access to and oversight of the MR ENVIRONMENT, and for hearing protection;

– demarcating, maintaining and controlling access to the B HAZARD AREA and the MR

ENVIRONMENT, including
• screening of any person entering this environment;

• confirming that no materials or equipment entering this environment pose a HAZARD.

– emergency procedures for (rapid) removal of the PATIENT who is in the B HAZARD AREA;

– emergency procedures related to a potential QUENCH of a superconductive magnet, when

applicable;
– rules to minimize and to limit the exposure of MR workers to EMF;
– establishing and ensuring adequate preventive maintenance;
– evaluation and implementation of local regulations.
This fourth edition aligns with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and

IEC 60601-1:2005/AMD2:2020 and the associated updates of the collateral standards.

---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-33:2022 © IEC 2022
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-33: Particular requirements for the basic safety and essential
performance of magnetic resonance equipment for medical diagnosis
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC
RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.

NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate

MR EQUIPMENT and 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.
201.1.2 Object
Replacement:

The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE

requirements for MR EQUIPMENT to provide protection for the PATIENT and the MR WORKER.

NOTE This document presumes that the MR WORKERs are screened, trained and instructed in their duties.

201.1.3 Collateral standards
Addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.

IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 applies as modified in Clause 202.

IEC 60601-1-3 [1], IEC 60601-1-9 [2], IEC 60601-1-10 [3], IEC 60601-1-11 [4] and

IEC 60601-1-12 [5] do not apply. All other published collateral standards in the IEC 60601-1

series apply as published.
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IEC 60601-2-33:2022 © IEC 2022 – 9 –
201.1.4 Particular standards
Addition:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard, viz.

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to that of the general

standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1

of the general standard) or applicable collateral standard with the prefix "20x" where x is the

final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses

the content of Clause 4 of the 60601-1-2 collateral standard, 208.4 in this document addresses

the content of Clause 4 of the 60601-1-8 collateral standard, etc.). The changes to the text of

the general standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text in this document.

"Addition" means that the text of this document is additional to the requirements of the general

standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However due to the fact that definitions in the general standard

are numbered 3.1 through 3.154, additional definitions in this document are numbered

beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items

aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to IEC 60601-1:2005,

IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral

standards and this document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subcl

...

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