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.

General Information

Status
Published
Publication Date
09-Mar-2010
Current Stage
PPUB - Publication issued
Start Date
10-Mar-2010
Completion Date
10-Mar-2010
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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
IEC 60601-2-33:2010
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
CODE PRIX
ICS 11.040.55 ISBN 978-2-88910-221-1
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

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

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

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with the International Organization for Standardization (ISO) in accordance with conditions determined by

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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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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

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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.

International standard IEC 60601-2-33 has been prepared by IEC subcommittee 62B:

Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

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.
---------------------- Page: 6 ----------------------
60601-2-33 © IEC:2010 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62B/777/FDIS 62B/782/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the seventeen 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 standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC

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

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

with this standard;

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

mandatory for compliance with this standard;

– “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 series, published under the general title: Medical electrical

equipment, can be found on the IEC website.
---------------------- Page: 7 ----------------------
– 6 – 60601-2-33 © IEC:2010

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.

The contents of the corrigenda 1 (March 2012) and 2 (February 2016) have been included in

this copy.

IMPORTANT – The 'colour inside' logo on the cover page of this publication 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 ----------------------
60601-2-33 © IEC:2010 – 7 –
* INTRODUCTION

This particular standard is written at a moment in which the technical evolution of

MR EQUIPMENT is in rapid progress and the scientific foundation of its safe use is still

expanding.

This International Standard addresses technical aspects of the medical diagnostic MR SYSTEM

and the MR EQUIPMENT therein related to the safety of PATIENTS examined with this system, the

safety of the MR WORKER involved with its operation and the safety of the MR WORKER involved

with the development, manufacturing, installation, and servicing of the MR SYSTEM. Where

limits of electromagnetic fields (EMF) exposure of PATIENTS and MR WORKERS are stated, these

limits do not imply that such levels of exposure can be assumed to be acceptable for workers

in other professional settings and for the population at large. The limits provide a sensible

balance between RISKS for the PATIENTS and MR WORKERS and benefits for the PATIENTS.

Organizational aspects of safety are the task of the RESPONSIBLE ORGANIZATION. This task

includes adequate training of staff, rules of access to the MR SYSTEM, qualification of staff for

decisions that are related to safety, definition of medical responsibility and specific

requirements for personnel following from that responsibility when the PATIENT is in or near

the MR SYSTEM.
Examples of such organizational aspects are:
− operation in FIRST LEVEL CONTROLLED OPERATING MODE;
− emergency procedures for resuscitation of the PATIENT who is in the MR SYSTEM;

− emergency procedures after a QUENCH of the superconductive magnet when present;

− set-up and maintenance of a protocol for screening the PATIENT for contraindications or for

conditions that may affect acceptable exposure;

− rules for ROUTINE MONITORING and for MEDICAL SUPERVISION of the PATIENT during the exam.

− rules to minimize and to limit the exposure of MR WORKERS to EMF.

Extensive rationale is provided in Annex AA for some of the definitions and requirements in

order to provide the user of this standard with a reasonably complete access to the source

material that was used in support of the considerations during drafting.

The relationship of this particular standard with IEC 60601-1 and the collateral standards is

explained in subclauses 201.1.3 and 201.1.4.

The introduced EMF exposure limits required in this standard for an MR WORKER will never

exceed those allowed for PATIENTS All exposure limits allowed for a PATIENT and for an MR

WORKER are expected to protect them against negative health effects and unacceptable RISKS.

For the exposure to static magnetic fields, subjective short-term physiological and sensory

effects are expected. These influence the well being of the MR WORKER marginally and only

during or shortly after exposure.

For the exposure to GRADIENT OUTPUT and RF transmit fields, normally no short-term

physiological and sensory effects are expected for MR WORKERS.

In addition no experimental or theoretical basis for cumulative biological effects in humans,

resulting from exposure at the allowed levels has been generally accepted.

The requirements for acoustic noise exposure are different for PATIENTS and MR WORKERS.

---------------------- Page: 9 ----------------------
– 8 – 60601-2-33 © IEC:2010
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 the general standard 1F0F applies, except as follows:
201.1.1 Scope
Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.

This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to

ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.

The standard does not formulate ESSENTIAL PERFORMANCE requirements related to
INTERVENTIONAL MR EXAMINATIONS.
201.1.2 Object
Replacement:

The object of this particular standard 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 standard presumes that the MR WORKERS are properly medically screened, and properly trained and

instructed in their duties.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2007 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10

do not apply. All other published collateral standards in the IEC 60601-1 series apply as

published.
201.1.4 Particular standards
Replacement:
—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance
---------------------- Page: 10 ----------------------
60601-2-33 © IEC:2010 – 9 –

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.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix “201” (e.g. 201.1 in this standard 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

particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,

203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 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 of this particular standard.

"Addition" means that the text of this particular standard 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 particular standard.

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 3.139, additional definitions in this standard 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 standard" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references

NOTE Informative references are listed in the bibliography beginning on page 52H52H96.

Clause 2 of the general standard applies except as follows:
Replacement:
---------------------- Page: 11 ----------------------
– 10 – 60601-2-33  IEC:2010

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic compatibility –

Requirements and tests
Addition:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
NEMA MS 4:2006, Acoustic noise measurements procedure for diagnostic magnetic
resonance imaging devices

NEMA MS 8:2008, Characterization of the specific absorption rate (SAR) for magnetic

resonance imaging systems
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and

the following apply:

NOTE An index of defined terms is found beginning on page 53H104. A list of symbols used in the document is

provided in Table 201.101.
Addition:
* 201.3.201
B RMS
root mean square (rms) of B , the MR relevant radiofrequency magnetic induction
(B (t)) dt
B RMS .

where t is time, and t is the evaluation time, and is estimated at the RF transmit coil centre.

201.3.202
COMPLIANCE VOLUME
PATIENT accessible space in which compliance of GRADIENT OUTPUT is inspected

In MR EQUIPMENT with a cylindrical WHOLE BODY MAGNET, the COMPLIANCE VOLUME is a cylinder

with its axis coinciding with the magnet axis and with a radius of 0,20 m. and with a length

equal to the gradient coil

In MR EQUIPMENT with a TRANSVERSE FIELD MAGNET and a WHOLE BODY GRADIENT SYSTEM, the

COMPLIANCE VOLUME is a cylinder aligned with the patient’s axis, of length equal to the

...

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