EN 60601-2-33:2002/A1:2005
(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
Superseded by EN 60601-2-33:2010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 zahteve za varnost opreme za magnetno resonanco za medicinsko diagnostiko (IEC 60601-2- 33:2002/A1:2005)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2007
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DYDUQRVWRSUHPH]D
PDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR ,(& $
Medical electrical equipment - Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis (IEC 60601-2- 33:2002/A1:2005)
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-
33:2002/A1:2005)
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/A1:2005)
Ta slovenski standard je istoveten z: EN 60601-2-33:2002/A1:2005
ICS:
11.040.55
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60601-2-33/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2005
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/A1:2005)
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 für die medizinische Diagnostik
pour diagnostic médical (IEC 60601-2-33:2002/A1:2005)
(CEI 60601-2-33:2002/A1:2005)
This amendment A1 modifies the European Standard EN 60601-2-33:2002; it was approved by
CENELEC on 2005-11-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and 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
© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-33:2002/A1:2005 E
Foreword
The text of document 62B/573/FDIS, future amendment 1 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 A1 to
EN 60601-2-33:2002 on 2005-11-01.
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) 2006-08-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2008-11-01
__________
Endorsement notice
The text of amendment 1:2005 to the International Standard IEC 60601-2-33:2002 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
NORME CEI
INTERNATIONALE
IEC
60601-2-33
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
2005-08
Amendement 1
Appareils électromédicaux –
Partie 2-33:
Règles particulières de sécurité relatives aux
appareils à résonance magnétique utilisés
pour le diagnostic médical
Amendment 1
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
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
J
Commission Electrotechnique Internationale
PRICE CODE
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
60601-2-33 Amend. 1 IEC:2006 – 3 –
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
This bilingual version (2006-02) replaces the English version.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/573/FDIS 62B/586/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 French version of this amendment has not been voted upon.
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.
___________
Page 13
6.8.2 INSTRUCTIONS FOR USE
Replace, on page 18, the existing item pp) by the following:
pp) Recommended training
INSTRUCTIONS FOR USE shall recommend that training is needed for physicians and the
OPERATOR to operate the MR EQUIPMENT safely and effectively. This training shall include
emergency procedures, including those for the issues described in this subclause under
− cc) Emergency medical procedures
− ee) CONTROLLED ACCESS AREA
− mm) EMERGENCY FIELD SHUT DOWN UNIT
− nn) Fire precautions
− ss) Emergency actions in the event of a QUENCH.
Add, on page 18, the following new item ss):
* ss) Emergency actions in case of a QUENCH
The INSTRUCTIONS FOR USE shall include instructions on how to identify a QUENCH and how
to act in the event of a QUENCH, especially when the venting system of the
superconducting magnet system fails.
60601-2-33 Amend. 1 IEC:2006 – 5 –
Page 19
6.8.3 Technical description
Replace, on page 20, the existing item cc) by the following:
* cc) Safety provisions in the event of a quench
For MR EQUIPMENT equipped with superconducting magnets, the ACCOMPANYING
DOCUMENTS shall
– state the requirements for a venting system for the superconducting magnet which
connects the cryostat of the magnet to the outside atmosphere and which is designed
to withstand a QUENCH and to protect nearby persons in the event of a QUENCH;
– provide guidelines for the construction (dimensions, position, assembly and material to
be applied) of the venting system for the superconducting magnet inside and outside
the examination room;
– recommend a preventive maintenance program, which states that regular checks of the
adequateness of the function of the venting system for the superconducting magnet
are to be made;
– state requirements for the design of the examination room to increase safety of the
patient and other persons inside and outside the examination room in the event of
failure of the venting system during a quench. The suggested design shall address the
issues of reducing pressure build-up, temperature decrease and oxygen depletion
during a quench. A number of acceptable solutions for such provisions, demonstrated
to be effective by simulation or test, shall be listed, so that even when the venting
system of the superconducting magnet fails to work adequately, the chance of a
hazard for the PATIENT or other persons inside as well as outside the examination
room, as caused by PRESSURE build-up, temperatures decrease or oxygen depletion
during the QUENCH, is reduced considerably;
– state the need for the USER to establish an emergency plan for a quench, including a
situation in which the venting system for the superconducting magnet fails to function
adequately;
– state the need for possible extra control measures for the PATIENT ventilation system in
order not to expose the PATIENT to additional helium transported to the PATIENT via the
PATIENT ventilation system. The PATIENT ventilation system should have its inlet
opening in a safe place (such as at a low level in the examination room or directly
connected to the air-conditioning of the examination room), or be connected to a
QUENCH detector, so that the PATIENT ventilation system can be automatically controlled
when a QUENCH occurs and will not transport helium to the PATIENT inside the scanner.
NOTE 1 The venting system for the superconducting magnet is considered to be the cryogenic vent pipe and all
the extra components necessary to safely accommodate a QUENCH.
NOTE 2 Examination room configurations demonstrated by simulation or test that are acceptable include:
− configurations in which the RF door opens outwards or is a sliding RF door;
− configurations in which the RF door opens inwards, if these include extra precautions to prevent PRESSURE
build up. This can be realized by one of the following
• an extra examination room ventilator system, which can be switched on (possibly automatically via an
oxygen monitor in the ceiling of the examination room to detect the escape of helium gas) in the
event of a QUENCH; or
• an opening in the wall or ceiling of the examination room, venting towards an open area; or
60601-2-33 Amend. 1 IEC:2006 – 7 –
• a possibility of opening the observation window in the examination room outward or by sliding; or
• a second independent venting system for the superconducting magnet that remains operational in
case the regular venting system for the superconducting magnet is obstructed; or
• equivalent methods demonstrated to be effective by simulation or test.
Page 45
Annex BB – Guidance and rationale for particular subclauses
Add, on page 57, a rationale for subclause item 6.8.2 ss) as follows:
Concerning 6.8.2 ss)
In addition to the information given in item cc) of 6.8.2 on emergency medical procedures and
item ff) of 6.8.2 on liquid and gaseous cryogens, this item provides information pertinent to
emergencies present in the event that magnet helium gas escapes from the magnet into the
examination room or other adjacent rooms during a QUENCH. This situation may be present
when the venting system of the superconducting magnet fails either in part or fully during a
magnet QUENCH. In this case, hazards may be present for the personnel involved. The
information provided here will be useful for the OPERATOR in establishing an emergency plan
adapted to local requirements.
While a QUENCH as such is a rare event, the additional failure of a venting system of the
magnet is even more unlikely. Although thousands of MR SYSTEMS are in operation, there
have been only a few reports to date regarding accidents or near accidents involving personal
injuries in relationship to a QUENCH. Nevertheless, the MANUFACTURERS are required to point
out the potential hazard of the combined event and to provide information pertinent to this
type of emergency. Note that the information covers the highly unlikely, yet possibly serious
event of a malfunctioning venting system at the time of a quench of the superconducting
magnet.
What is a QUENCH?
During a QUENCH, the magnet loses its super-conductivity. The magnetic field ramps down in a
matter of seconds – typically lasting approximately 20 seconds. The magnet begins to warm
up. Liquid helium boils off at a rate of 500 to 1 500 l within a few minutes and expands
quickly. The exact boil-off rate amount depends on the fill level as well as the field strength of
the magnet. A 3 T magnet may have a higher boil-off rate than a 1,5 T magnet. One litre of
liquid helium translates into approximately 700 l of gaseous helium. During maximum
conditions this means approximately 1 000 m of gas. A manual QUENCH may be initiated by
activating the Emergency field shut down unit. Another source for quenching is when the
helium fill level decreases to a point where the magnet begins to warm up. In rare instances,
a spontaneous QUENCH may be observed that cannot be explained by the presence of obvious
causes.
Hissing or whistling noises caused by the quickly escaping stream of cold helium gas may
accompany a QUENCH. Plumes of white fog sink to the floor mainly from the upper part of the
magnet from the vicinity of the QUENCH line due to condensation of both water vapour and air.
The stream of helium gas diminishes in a matter of minutes. Air near the non-insulated
components of the magnet and the QUENCH line condenses into liquid air and drips to the
floor.
60601-2-33 Amend. 1 IEC:2006 – 9 –
Risks associated with a failing venting system
The purpose of the venting system of the superconducting magnet is to securely exhaust
gaseous helium to the outside. The main element of this system is a conduit that is designed
to transport the escaping helium gas to a safe open area. The possibility of a QUENCH should
be taken into careful consideration during the design of both the magnet and the venting
system of the superconducting magnet. As a result, a QUENCH should be completely harmless
to personnel. Also, neither the magnet nor the MR installations as such should be subject to
damage during a QUENCH.
An emergency situation will arise if a quench venting system fails. Helium is lighter than air,
and is non-poisonous and non-flammable. However, since it displaces oxygen, the risk of
suffocation exists. Cryogenic helium escaping into the ambient air leads to white clouds
caused by condensation. These clouds will adversely affect visibility.
Persons may be rendered unconscious by the amount of helium ent
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