EN 60601-2-33:2002/A2:2008
(Amendment)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
Corrigendum to EN issued November 2008 * Superseded by EN 60601-2-33:2010
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik
Appareils électromédicaux - Partie 2-33: Règles particulières de sécurité relatives aux appareils à résonance magnétique utilisés pour le diagnostic médical
Medicinska električna oprema - 2-33. del: Posebne varnostne zahteve za opremo za magnetno resonanco za medicinsko diagnostiko (IEC 60601-2-33:2002/A2:2007)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR
]DPDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR ,(& $
Medical electrical equipment - Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002/A2:2007)
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-
33:2002/A2:2007)
Appareils électromédicaux - Partie 2-33: Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-
33:2002/A2:2007)
Ta slovenski standard je istoveten z: EN 60601-2-33:2002/A2:2008
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-2-33/A2
NORME EUROPÉENNE
March 2008
EUROPÄISCHE NORM
ICS 11.040.55
English version
Medical electrical equipment -
Part 2-33: Particular requirements for the safety
of magnetic resonance equipment for medical diagnosis
(IEC 60601-2-33:2002/A2:2007)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-33: Règles particulières Teil 2-33: Besondere Festlegungen für die
de sécurité relatives aux appareils Sicherheit von Magnetresonanzgeräten
à résonance magnétique utilisés für die medizinische Diagnostik
pour le diagnostic médical (IEC 60601-2-33:2002/A2:2007)
(CEI 60601-2-33:2002/A2:2007)
This amendment A2 modifies the European Standard EN 60601-2-33:2002; it was approved by CENELEC on
2008-02-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-33:2002/A2:2008 E
Foreword
The text of document 62B/663/FDIS, future amendment 2 to IEC 60601-2-33:2002, prepared by SC 62B,
Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to
the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A2 to
EN 60601-2-33:2002 on 2008-02-01.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2008-11-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2011-02-01
__________
Endorsement notice
The text of amendment 2:2007 to the International Standard IEC 60601-2-33:2002 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
IEC 60601-2-33
Edition 2.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 2
AMENDEMENT 2
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
R
CODE PRIX
ICS 11.040.55 ISBN 2-8318-9358-5
– 2 – 60601-2-33 Amend.2 © IEC:2007
FOREWORD
This amendment has been prepared by subcommittee 62B: Medical imaging equipment, of
IEC Technical Committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/663/FDIS 62B/675/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the maintenance result 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.
_____________
INTRODUCTION to Amendment 2
This second amendment to IEC 60601-2-33 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. The new aspect introduced in this second amendment addresses
the fact that in some countries electromagnetic field (EMF) exposure of workers is or will be
limited by law.
Page 11
INTRODUCTION
Replace the second paragraph by the following:
SYSTEM
This International Standard addresses technical aspects of the medical diagnostic MR
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 WORKER 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.
60601-2-33 Amend.2 © IEC:2007 – 3 –
Add, after the second paragraph, the following new text:
The introduced EMF exposure limits required in this standard for an MR WORKER are equal to
those allowed for PATIENTS. All exposure levels allowed for a PATIENT and for an MR WORKER
protect them against negative instantaneous and long-term health effects.
Subjective short-term physiological and sensory effects are expected for the exposure to
static magnetic fields only, 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.
Add, to the list of examples of organisational aspects in the fourth paragraph, the following
new item:
− rules to minimize and to limit the exposure of MR WORKERS.
Page 13
1 Scope and object
1.2 Object
Replace the first paragraph by the following:
This particular standard establishes requirements for the safety of MR EQUIPMENT to provide
protection for the PATIENT and the MR WORKER.
NOTE This standard presumes that the MR WORKERS are properly screened medically, and properly trained and
instructed in their duties.
Page 15
2 Terminology and definitions
2.12 Miscellaneous
Add, on page 21, the following new definition:
2.12.107
MR WORKER
person that because of his/her profession has to enter the CONTROLLED ACCESS AREA or
equivalent of the MAGNETIC RESONANCE SYSTEM
NOTE Other persons like MR volunteers and PATIENT carers are not covered by this definition, however
OPERATORS and staff are included in this definition (see rationale)
Page 27
6.8.2 INSTRUCTIONS FOR USE
aa) Pre-screening prior to an MR EXAMINATION
Replace the title of 6.8.2 aa) by:
aa) Pre-screening of the PATIENT and MR WORKER
– 4 – 60601-2-33 Amend.2 © IEC:2007
Replace the first paragraph of 6.8.2 aa) as follows:
INSTRUCTIONS FOR USE shall provide clear recommendations to the USER regarding pre-
screening of PATIENTS and MR WORKERS. This specifically applies to those PATIENTS and MR
WORKERS who could be placed at risk due to their professional activity, past medical history,
present medical state and/or the physical environment of the MR EQUIPMENT. These
instructions shall indicate the need for a pre-screening program to identify such PATIENTS and
MR WORKERS at risk, and shall provide recommendations to adequately safeguard these
PATIENTS and MR WORKERS from injury. For the MR WORKER especially the risk due to the past
professional activity, which may have caused accidental implantation of ferromagnetic
materials, shall be considered.
dd) Excessive acoustic noise
Replace the title of 6.8.2 dd) by:
dd) Exposure of the PATIENT and MR WORKER to excessive acoustic noise
Replace the existing last dashed item by the following:
– shall draw attention to the fact that in some countries legislation may exist covering the
exposure of MR WORKERS to noise.
Add a last dash to 6.8.2 dd):
– shall state that for tasks in the CONTROLLED ACCESS AREA during scanning, the MR
WORKER shall wear adequate hearing protection to reach compliance with the rules for
protection of workers to noise.
hh) Static magnetic field
Replace the title of item hh) by:
hh) Exposure of the PATIENT and MR WORKER to the static magnetic field
Replace the first bullet of 6.8.2 hh) by:
– explain the possible effects that PATIENTS and MR WORKERS may experience when the
static magnetic field is above the level of NORMAL OPERATION MODE, paying particular
attention to the effects that may be experienced if the PATIENT or MR WORKER’S head is
moved rapidly while inside or close to the MR EQUIPMENT, including dizziness, vertigo,
and a metallic taste in the mouth;
Add the following dashed items:
– explain that when the main static magnetic field is higher than 2 T and not exceeding
4 T, the MR SYSTEM is continuously operating in the FIRST LEVEL CONTROLLED
OPERATION MODE and therefore ensure that MEDICAL SUPERVISION is provided for all
PATIENTS
– explain that adequate training shall be given to MR WORKERS to minimise adverse
health effects arising from the high static magnetic field. Explain the health effects
related to the increased static magnetic fields and explain the possible changes in the
MR compatibility of the tools and accessories used by the MR WORKER, as a function of
the value of the static magnetic field.
– explain that when the main static magnetic field is higher than 4 T, the MR system is
continuously operating in the SECOND LEVEL CONTROLLED OPERATION MODE and
therefore ensure that MEDICAL SUPERVISION is provided for all PATIENTS. Explain that in
this situation MR WORKERS shall not be allowed to access the MR EQUIPMENT without
local approval as required.
60601-2-33 Amend.2 © IEC:2007 – 5 –
ii) Time varying magnetic fields
Replace the title of item ii) by the following:
ii) Exposure of the PATIENT to time varying magnetic fields
Replace the first paragraph by the following:
For MR EQUIPMENT that is capable of operation at levels of GRADIENT OUTPUT above the
NORMAL OPERATING MODE, the INSTRUCTIONS FOR USE shall draw attention to risk factors, which
may increase the potential for peripheral nerve stimulation for the PATIENT and they shall
describe ways for the USER to mitigate these risk factors. The INSTRUCTIONS FOR USE shall:
jj) Radio frequency magnetic fields
Replace title of the item jj) by:
jj) Exposure of the PATIENT to radio frequency magnetic fields
Replace the first paragraph by the following:
The INSTRUCTIONS FOR USE shall draw attention to risk factors, which may increase the
potential for local excessive RF heating of the PATIENT and they shall describe ways for the
USER to mitigate these risk factors. These factors include:
kk) Occupational exposure
Replace the existing text of this item by the following new text:
The INSTRUCTIONS FOR USE shall draw attention to the fact that MR WORKERS can be exposed
to the electromagnetic fields (EMF) emitted by the MR EQUIPMENT. They shall provide
sufficient information relating to the risks from these exposures to enable safe working
procedures for the MR WORKER. The relevant requirements of 6.8.2 ii) and jj) for the PATIENT
shall also apply for the MR WORKER. This information shall also include
– specification of areas to which access by the MR WORKER is restricted, if any;
– the actual levels of the exposure in all areas accessible to the MR WORKER, expressed in
proper units for the static magnetic field (see 6.8.2 hh) and 51.104), the GRADIENT OUTPUT
(see 6.8.2.ii) and 51.102) and the RF transmit field (see 6.8.2 jj) and 51.103) generated by
the MR EQUIPMENT;
– instructions that the MR WORKER shall be informed and trained sufficiently so that they can
perform all their tasks safely in a way that minimizes their exposure to EMF emitted by the
MR EQUIPMENT;
– a statement that there is a possibility that mild peripheral nerve stimulation (PNS) may be
induced in the PATIENT and MR WORKER when exposed to the gradients in the FIRST LEVEL
CONTROLLED OPERATION MODE;.
The risk factors associated with the expected exposure levels for the MR WORKER shall be
explained. A description of ways for the MR WORKER to mitigate these risk factors shall be
given.
Known factors to draw attention to are the following:
– The possible physiological
...
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