IEC 60601-2-33:2002
(Main)Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
Establishes requirements for the safety of magnetic resonance equipment to provide protection for the patient. It establishes requirements to provide information to the operator, staff associated with magnetic resonance equipment and the general public. It also provides methods for demonstrating compliance with those requirements.
Appareils électromédicaux - Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance magnétique utilisés pour le diagnostic médical
Etablit les exigences de sécurité des appareils à rm afin d'assurer la protection du patient. Etablit des exigences pour fournir des informations à l'opérateur, au personnel associé aux appareils à rm et au grand public. Fournit également des méthodes pour démontrer la conformité à ces exigences.
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INTERNATIONAL IEC
STANDARD
60601-2-33
Second edition
2002-05
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety
of magnetic resonance equipment
for medical diagnosis
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives
aux appareils à résonance magnétique
pour diagnostic médical
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables
you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (www.iec.ch/JP.htm) is also
available by email. Please contact the Customer Service Centre (see below) for
further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: custserv@iec.ch
Tel: +41 22 919 02 11
Fax: +41 22 919 03 00
INTERNATIONAL IEC
STANDARD
60601-2-33
Second edition
2002-05
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety
of magnetic resonance equipment
for medical diagnosis
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives
aux appareils à résonance magnétique
pour diagnostic médical
IEC 2002 Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
XC
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue
– 2 – 60601-2-33 IEC:2002(E)
CONTENTS
FOREWORD .4
INTRODUCTION.6
SECTION ONE: GENERAL
1 Scope and object.7
2 Terminology and definitions.8
3 General requirements .13
6 Identification, marking and documents.13
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
26 Vibration and noise.21
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility .22
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
45 Pressure vessels and parts subject to PRESSURE .23
49 Interruption of the power supply.23
SECTION EIGHT: ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output.23
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .42
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout.42
Figures
101 Gradient waveform and EFFECTIVE STIMULUS DURATION .12
102 Gradient output waveform for performing measurements of acoustic noise .22
103 Limits for cardiac and peripheral nerve stimulation .27
104 Reduction of WHOLE BODY SAR at high temperatures and high humidity. .30
105 Hardware set-up for pulse-energy method for the measurement of SAR with
a quadrature RF transmit coil .36
60601-2-33 IEC:2002(E) – 3 –
106 Hardware set-up for pulse-energy method for the measurement of SAR
with a linear RF transmit coil .36
BB.1 Static magnetic fields: flow potentials and retardation.57
BB.2 Experimental data on PNS threshold of human volunteers in WHOLE BODY
MR EQUIPMENT.63
BB.3 Double logarithmic plot of experimental threshold values for peripheral nerve
stimulation.64
BB.4 Response value R(t) generated by convolution of a rectangular stimulus dB/dt
and a nerve impulse response function n(t-θ).68
BB.5 Gradient waveform G, stimulus waveform dB/dt and response value R,
for a trapezoid EPI waveform starting at t = 0 .69
BB.6 Threshold values dB/dt for two gradient waveforms, plotted against EFFECTIVE
STIMULUS DURATION .69
BB.7 Threshold value of dB/dt for a sinusoid gradient waveform, as function of the
number of half periods in the waveform .70
BB.8 SAR limits for the exposed mass of a PATIENT.73
Tables
101 List of symbols .12
102 Rheobase values per type of gradient system.27
103 Weight factors for summation of the maximum output O per gradient unit .28
i
104 Temperature limits.28
105 SAR limits.29
BB.1 Static field occupational standards .55
Appendix L References – Publications mentioned in this standard.43
Annex AA (informative) Examples of warning signs and prohibitive signs.44
Annex BB (informative) Guidance and rationale for particular subclauses .45
Bibliography.75
Index of defined terms .82
– 4 – 60601-2-33 IEC:2002(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-33 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1995 and constitutes
a technical revision.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62B/462/FDIS 62B/467/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annexes AA and BB are for information only.
60601-2-33 IEC:2002(E) – 5 –
In this standard, the following print types are used:
− requirements, compliance with which can be tested, and definitions: roman type;
− explanations, advice, notes, general statements and exceptions: smaller roman type;
− test specifications: italic type;
− TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD OR IN IEC 60788: SMALL CAPITALS
The committee has decided that the contents of this publication will remain unchanged
until 2005-06. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
– 6 – 60601-2-33 IEC:2002(E)
INTRODUCTION
This Particular Standard is written at a moment in which the technical evolution of MAGNETIC
RESONANCE EQUIPMENT is in rapid progress and the scientific foundation of its safe use is still
expanding.
The standard addresses technical aspects of the medical diagnostic MR SYSTEM and the MR
EQUIPMENT therein, related to safety of PATIENTS examined with this system and personnel
involved with its operation. Where limits of exposure of PATIENTS and medical staff are stated,
these limits do not imply that such levels of exposure can be assumed to be acceptable for
the population at large. Rather the implication is that the limits provide for the PATIENT a
sensible balance between risk and benefit and for the medical staff a balanced risk, given
their responsibility for the wellbeing of the PATIENT.
Organisational aspects of safety are the task of the USER. 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 organisational aspects are:
− operation in first controlled 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.
Extensive rationale is provided in Annex BB for some of the definitions and requirements in
order to provide the USER of this standard with a reasonably complete access to
...
NORME CEI
INTERNATIONALE
IEC
60601-2-33
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2002-05
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés
pour le diagnostic médical
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety of
magnetic resonance equipment for
medical diagnosis
Numéro de référence
Reference number
CEI/IEC 60601-2-33:2002
Numérotation des publications Publication numbering
Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are
sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For
devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.
Editions consolidées Consolidated editions
Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its
CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1
exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 refer, respectively, to the base publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
base incorporant l’amendement 1, et la publication de the base publication incorporating amendments 1
base incorporant les amendements 1 et 2. and 2.
Informations supplémentaires Further information on IEC publications
sur les publications de la CEI
Le contenu technique des publications de la CEI est The technical content of IEC publications is kept
constamment revu par la CEI afin qu'il reflète l'état under constant review by the IEC, thus ensuring that
actuel de la technique. Des renseignements relatifs à the content reflects current technology. Information
cette publication, y compris sa validité, sont dispo- relating to this publication, including its validity, is
nibles dans le Catalogue des publications de la CEI available in the IEC Catalogue of publications
(voir ci-dessous) en plus des nouvelles éditions, (see below) in addition to new editions, amendments
amendements et corrigenda. Des informations sur les and corrigenda. Information on the subjects under
sujets à l’étude et l’avancement des travaux entrepris consideration and work in progress undertaken by the
par le comité d’études qui a élaboré cette publication, technical committee which has prepared this
ainsi que la liste des publications parues, sont publication, as well as the list of publications issued,
également disponibles par l’intermédiaire de: is also available from the following:
• Site web de la CEI (www.iec.ch) • IEC Web Site (www.iec.ch)
• Catalogue des publications de la CEI • Catalogue of IEC publications
Le catalogue en ligne sur le site web de la CEI The on-line catalogue on the IEC web site
(www.iec.ch/searchpub) vous permet de faire des (www.iec.ch/searchpub) enables you to search by a
recherches en utilisant de nombreux critères, variety of criteria including text searches,
comprenant des recherches textuelles, par comité technical committees and date of publication. On-
d’études ou date de publication. Des informations en line information is also available on recently
ligne sont également disponibles sur les nouvelles issued publications, withdrawn and replaced
publications, les publications remplacées ou retirées, publications, as well as corrigenda.
ainsi que sur les corrigenda.
• IEC Just Published • IEC Just Published
Ce résumé des dernières publications parues This summary of recently issued publications
(www.iec.ch/online_news/justpub) est aussi dispo- (www.iec.ch/online_news/justpub) is also available
nible par courrier électronique. Veuillez prendre by email. Please contact the Customer Service
contact avec le Service client (voir ci-dessous) Centre (see below) for further information.
pour plus d’informations.
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Si vous avez des questions au sujet de cette If you have any questions regarding this
publication ou avez besoin de renseignements publication or need further assistance, please
supplémentaires, prenez contact avec le Service contact the Customer Service Centre:
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Tél: +41 22 919 02 11 Tel: +41 22 919 02 11
Fax: +41 22 919 03 00 Fax: +41 22 919 03 00
.
NORME CEI
INTERNATIONALE
IEC
60601-2-33
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2002-05
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés
pour le diagnostic médical
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety of
magnetic resonance equipment for
medical diagnosis
IEC 2002 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
XD
PRICE CODE
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International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
– 2 – 60601-2-33 CEI:2006
SOMMAIRE
AVANT-PROPOS .6
INTRODUCTION.10
SECTION UN: GÉNÉRALITÉS
1 Domaine d’application et objet.12
2 Terminologie et définitions.14
3 Exigences générales .24
6 Identification, marquage et documentation .26
SECTION DEUX: CONDITIONS D’ENVIRONNEMENT
SECTION TROIS: PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
SECTION QUATRE: PROTECTION CONTRE LES RISQUES MÉCANIQUES
26 Vibrations et bruit .42
SECTION CINQ: PROTECTION CONTRE LES RISQUES DUS AUX
RAYONNEMENTS NON DESIRÉS OU EXCESSIFS
36 Compatibilité électromagnétique.46
SECTION SIX: PROTECTION CONTRE LES RISQUES D’IGNITION DE
MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION SEPT: PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
45 Réservoirs et parties sous PRESSION.48
49 Coupure de l’alimentation.48
SECTION HUIT: PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
51 Protection contre les caractéristiques de sortie présentant des risques .48
SECTION NEUF: FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut .90
SECTION DIX: RÈGLES DE CONSTRUCTION
59 Construction et montage.90
Annexe L Références – Publications mentionnées dans la présente norme .92
Annexe AA (informative) Exemples de signaux d’avertissement et de signaux
d’interdiction .94
Annexe BB (informative) Guide et justifications pour des paragraphes particuliers.96
Bibliographie.164
Index des termes définis .180
60601-2-33 IEC:2006 – 3 –
CONTENTS
FOREWORD .7
INTRODUCTION.11
SECTION ONE: GENERAL
1 Scope and object.13
2 Terminology and definitions.15
3 General requirements .25
6 Identification, marking and documents.27
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
26 Vibration and noise.43
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility.47
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
45 Pressure vessels and parts subject to PRESSURE .49
49 Interruption of the power supply .49
SECTION EIGHT: ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output.49
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .91
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout.91
Appendix L References – Publications mentioned in this standard.93
Annex AA (informative) Examples of warning signs and prohibitive signs.95
Annex BB (informative) Guidance and rationale for particular subclauses.97
Bibliography.165
Index of defined terms .181
– 4 – 60601-2-33 CEI:2006
Figure 101 – Forme d’onde de gradient et DURÉE DE STIMULATION EFFECTIVE.22
Figure 102 – Forme d’onde de gradient d’amplitude de sortie du champ magnétique
pour effectuer les mesures de bruit acoustique .46
Figure 103 – Limites de stimulation cardiaque et du système nerveux périphérique .58
Figure 104 – Réduction des limites du TAS POUR LE CORPS ENTIER pour des
températures et une humidité élevées.64
Figure 105 – Montage matériel pour la méthode à impulsion d'énergie pour la mesure
du TAS avec une bobine d’émission RF en quadrature .78
Figure 106 – Montage matériel pour la méthode à impulsion d'énergie pour la mesure
du TAS avec une bobine d’émission RF linéaire .78
Figure BB.2 – Données expérimentales sur le seuil de PNS de volontaires humains
dans les APPAREILS À RM POUR LE CORPS ENTIER .138
Figure BB.3 – Tracé logarithmique double des valeurs de seuil expérimentales pour la
stimulation du nerf périphérique.140
Figure BB.4 – Valeur de réponse R(t) produite par convolution d’un stimulus
rectangulaire dB/dt et d’une fonction de réponse d’impulsion nerveuse n(t-θ).150
Figure BB.5 – Forme d’onde de gradient G, forme d’onde de stimulus dB/dt et valeur
de réponse R, pour une forme d'onde trapézoïdale d’EPI commençant à t = 0 .150
Figure BB.6 – Valeurs de seuil dB/dt pour deux formes d’ondes de gradient, tracées
par rapport à la DURÉE DE STIMULATION EFFECTIVE .152
Figure BB.7 – Valeur de seuil de dB/dt pour une forme d’onde de gradient sinusoïdale,
en fonction du nombre de demi-périodes dans la forme d’onde.152
Figure BB.8 – Limites du TAS pour la masse exposée d’un PATIENT.160
Tableau 101 – Liste des symboles .24
Tableau 102 – Valeurs de rhéobase par type de système de gradient.58
Tableau 103 – Coefficients de pondération pour la sommation de la sortie maximale O
i
par UNITÉ DE GRADIENT.60
Tableau
...
NORME CEI
INTERNATIONALE
IEC
60601-2-33
INTERNATIONAL
Edition 2.1
STANDARD
2006-02
Edition 2:2002 consolidée par l'amendement 1:2005
Edition 2:2002 consolidated with amendment 1:2005
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés
pour le diagnostic médical
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety
of magnetic resonance equipment
for medical diagnosis
Numéro de référence
Reference number
CEI/IEC 60601-2-33:2002+A1:2005
Numérotation des publications Publication numbering
Depuis le 1er janvier 1997 , les publications de la CEI As from 1 January 1997 all IEC publications are
sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For
devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.
Editions consolidées Consolidated editions
Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its
CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1
exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 re fer, respectively, to the ba se publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
base incorporant l’amendement 1, et la publication de the base pu blication incorporating amendments 1
base incorporant les amendements 1 et 2. and 2.
Informations supplémentaires Further information on IEC publications
sur les publications de la CEI
Le contenu technique des publications de la CEI est The technical content of IEC publications is kept
constamment revu par la CEI afin qu'il reflète l'état under constant review by the IEC, thus ensuring that
actuel de la technique. Des renseignements relatifs à the content reflects current technology. Information
cette publication, y compris sa validité, sont dispo- relating to this publication, including its validity, is
nibles dans le Catalogue des publications de la CEI available in the IEC C atalogue of pu blications
(voir ci-dessous) en plus des nouvelles éditions, (see below) in addition to new editions, amendments
amendements et corrigenda. Des informations sur les and corrigenda. Information on the subjects under
sujets à l’étude et l’avancement des travaux entrepris consideration and work in progress undertaken by the
par le comité d’études qui a élaboré cette publication, technical committee which has prepared this
ainsi que la liste des publications parues, sont publication, as well as the list of publications issued,
également disponibles par l’intermédiaire de: is also available from the following:
• Site web de la CEI (www.iec.ch) • IEC Web Site (www.iec.ch)
• Catalogue des publications de la CEI • Catalogue of IEC publications
Le catalogue en ligne sur le site web de la CEI The on-line catalogue on the IEC w eb site
(www.iec.ch/searchpub) vous permet de faire des (www.iec.ch/searchpub) enables you to search by a
recherches en utilisant de nombreux critères, variety of cr iteria including text searches,
comprenant des re cherches textuelles, par comité technical committees and date of publication. On-
d’études ou date de publication. Des informations en line information is a lso available on re cently
ligne sont également disponibles sur les nouvelles issued publications, withdrawn and repla ced
publications, les publications remplacées ou retirées, publications, as well as corrigenda.
ainsi que sur les corrigenda.
• IEC Just Published • IEC Just Published
Ce résumé des dernières publications parues This summary of re cently issued pu blications
(www.iec.ch/online_news/justpub) est aussi dispo- (www.iec.ch/online_news/justpub) is also available
nible par courrier électronique. Veuillez prendre by email. Plea se contact the Customer Se rvice
contact avec le Service client (voir ci-dessous) Centre (see below) for further information.
pour plus d’informations.
• Service clients • Customer Service Centre
Si vous avez des qu estions au sujet de cette If you have any questions regarding this
publication ou avez be soin de rense ignements publication or need furth er assistance, please
supplémentaires, prenez contact avec le Service contact the Customer Service Centre:
clients:
Email: custserv@iec.ch Email: custserv@iec.ch
Tél: +41 22 919 02 11 Tel: +41 22 919 02 11
Fax: +41 22 919 03 00 Fax: +41 22 919 03 00
.
NORME CEI
INTERNATIONALE
IEC
60601-2-33
INTERNATIONAL
Edition 2.1
STANDARD
2006-02
Edition 2:2002 consolidée par l'amendement 1:2005
Edition 2:2002 consolidated with amendment 1:2005
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés
pour le diagnostic médical
Medical electrical equipment –
Part 2-33:
Particular requirements for the safety
of magnetic resonance equipment
for medical diagnosis
IEC 2006 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
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CODE PRIX
CR
Commission Electrotechnique Internationale
PRICE CODE
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
– 2 – 60601-2-33 CEI:2002+A1:2005
SOMMAIRE
AVANT-PROPOS .6
INTRODUCTION.10
SECTION UN: GÉNÉRALITÉS
1 Domaine d’application et objet.12
2 Terminologie et définitions.14
3 Exigences générales .24
6 Identification, marquage et documentation .26
SECTION DEUX: CONDITIONS D’ENVIRONNEMENT
SECTION TROIS: PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
SECTION QUATRE: PROTECTION CONTRE LES RISQUES MÉCANIQUES
26 Vibrations et bruit .46
SECTION CINQ: PROTECTION CONTRE LES RISQUES DUS AUX
RAYONNEMENTS NON DESIRÉS OU EXCESSIFS
36 Compatibilité électromagnétique.48
SECTION SIX: PROTECTION CONTRE LES RISQUES D’IGNITION DE
MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION SEPT: PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
45 Réservoirs et parties sous PRESSION.50
49 Coupure de l’alimentation.50
SECTION HUIT: PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
51 Protection contre les caractéristiques de sortie présentant des risques .50
SECTION NEUF: FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut .92
SECTION DIX: RÈGLES DE CONSTRUCTION
59 Construction et montage.92
Annexe L Références – Publications mentionnées dans la présente norme .94
Annexe AA (informative) Exemples de signaux d’avertissement et de signaux
d’interdiction .96
Annexe BB (informative) Guide et justifications pour des paragraphes particuliers.98
Bibliographie.178
Index des termes définis .194
60601-2-33 IEC:2002+A1:2005 – 3 –
CONTENTS
FOREWORD .7
INTRODUCTION.11
SECTION ONE: GENERAL
1 Scope and object.13
2 Terminology and definitions.15
3 General requirements .25
6 Identification, marking and documents.27
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
26 Vibration and noise.47
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility.49
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
45 Pressure vessels and parts subject to PRESSURE .51
49 Interruption of the power supply .51
SECTION EIGHT: ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output.51
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .93
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout.93
Appendix L References – Publications mentioned in this standard.95
Annex AA (informative) Examples of warning signs and prohibitive signs.97
Annex BB (informative) Guidance and rationale for particular subclauses.99
Bibliography.179
Index of defined terms .195
– 4 – 60601-2-33 CEI:2002+A1:2005
Figure 101 – Forme d’onde de gradient et DURÉE DE STIMULATION EFFECTIVE.22
Figure 102 – Forme d’onde de gradient d’amplitude de sortie du champ magnétique
pour effectuer les mesures de bruit acoustique .48
Figure 103 – Limites de stimulation cardiaque et du système nerveux périphérique .60
Figure 104 – Réduction des limites du TAS POUR LE CORPS ENTIER pour des
températures et une humidité élevées.66
Figure 105 – Montage matériel pour la méthode à impulsion d'énergie pour la mesure
du TAS avec une bobine d’émission RF en quadrature .80
Figure 106 – Montage matériel pour la méthode à impulsion d'énergie pour la mesure
du TAS avec une bobine d’émission RF linéaire .80
Figure BB.1 – Champs magnétiques statiques: potentiels de flux et réaction .124
Figure BB.2 – Données expérimentales sur le seuil de PNS de volontaires humains
dans les APPAREILS À RM POUR LE CORPS ENTIER .152
Figure BB.3 – Tracé logarithmique double des valeurs de seuil expérimentales pour la
stimulation du nerf périphérique.154
Figure BB.4 – Valeur de réponse R(t) produite par convolution d’un stimulus
rectangulaire dB/dt et d’une fonction de réponse d’impulsion nerveuse n(t-θ).164
Figure BB.5 – Forme d’onde de gradient G, forme d’onde de stimulus dB/dt et valeur
de réponse R, pour une forme d'onde trapézoïdale d’EPI commençant à t = 0 .164
Figure BB.6 – Valeurs de seuil dB/dt pour deux formes d’ondes de gradient, tracées
par rapport à la DURÉE DE STIMULATION EFFECTIVE .166
Figure BB.7 – Valeur de seuil de dB/dt pour une forme d’onde de gradient sinusoïdale,
en fonction du nombre de demi-périodes dans la forme d’onde.166
Figure BB.8 – Limites du TAS pour la masse exposée d’un PATIENT.174
Tableau 101 – Liste des symboles .
...
IEC 60601-2-33
Edition 2.2 2008-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-33: Particular requirements for the safety of magnetic resonance
equipment for medical diagnosis
Appareils électromédicaux –
Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance
magnétique utilisés pour le diagnostic médical
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IEC 60601-2-33
Edition 2.2 2008-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-33: Particular requirements for the safety of magnetic resonance
equipment for medical diagnosis
Appareils électromédicaux –
Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance
magnétique utilisés pour le diagnostic médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CT
CODE PRIX
ICS 11.040.55 ISBN 2-8318-9626-6
– 2 – 60601-2-33 © IEC:2002+A1:2005
+A2:2007
CONTENTS
FOREWORD.4
INTRODUCTION.6
INTRODUCTION (to Amendment 2) .7
SECTION ONE: GENERAL
1 Scope and object.8
2 Terminology and definitions.9
3 General requirements .14
6 Identification, marking and documents.15
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
26 Vibration and noise.25
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility.26
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
45 Pressure vessels and parts subject to PRESSURE .27
49 Interruption of the power supply .27
SECTION EIGHT: ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output.27
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .51
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
59 Construction and layout.51
Appendix L References – Publications mentioned in this standard.52
Annex AA (informative) Examples of warning signs and prohibitive signs.53
Annex BB (informative) Guidance and rationale for particular subclauses.55
Bibliography.98
Index of defined terms .106
60601-2-33 © IEC:2002+A1:2005 – 3 –
+A2:2007
Figure 101 – Gradient waveform and EFFECTIVE STIMULUS DURATION.13
Figure 102 – Gradient output waveform for performing measurements of acoustic noise.26
Figure 103 – Limits for cardiac and peripheral nerve stimulation .32
Figure 104 – Reduction of WHOLE BODY SAR limits at high temperatures and humidity.35
Figure 105 – Hardware set-up for pulse-energy method for the measurement of SAR
with a quadrature RF transmit coil .43
Figure 106 – Hardware set-up for pulse-energy method for the measurement of SAR
with a linear RF transmit coil.43
Figure 107 – Determination of the spatial maximum of the gradient output.40
Figure 108 – Determination of the B stray field.50
Figure BB.1 – Static magnetic fields: flow potentials and retardation.69
Figure BB.2 – Experimental data on PNS threshold of human volunteers in WHOLE
BODY MR EQUIPMENT.84
Figure BB.3 – Double logarithmic plot of experimental threshold values for peripheral
nerve stimulation .85
Figure BB.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 BB.5 – Gradient waveform G, stimulus waveform dB/dt and response value R,
for a trapezoid EPI waveform starting at t = 0 .90
Figure BB.6 – Threshold values dB/dt for two gradient waveforms, plotted against
EFFECTIVE STIMULUS DURATION .91
Figure BB.7 – Threshold value of dB/dt for a sinusoid gradient waveform, as function
of the number of half periods in the waveform.91
Figure BB.8 – SAR limits for the exposed mass of a PATIENT.95
Table 101 – List of symbols .14
Table 102 – Rheobase values per type of gradient system.32
Table 103 – Weight factors for summation of the maximum output O per GRADIENT UNIT.33
i
Table 104 – Temperature limits.33
Table 105 – SAR limits .34
Table BB.1 – Static field occupational standards.68
– 4 – 60601-2-33 © IEC:2002+A1:2005
+A2:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis
FOREWORD
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