EN 60601-2-33:2010/A2:2015

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

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.

Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Magnetresonanzgeräten für die medizinische Diagnostik

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 medical

Medicinska električna oprema - 2-33. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za magnetno resonanco za medicinsko diagnostiko - Dopolnilo A2

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MR OPREME in MR SISTEMOV, v nadaljevanju ME OPREME. Ta standard ne zajema uporabo MR OPREME zunaj PREDVIDENE UPORABE. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.

General Information

• Status: Published
• Publication Date: 17-Sep-2015
• Withdrawal Date: 22-Jul-2018
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 18-Sep-2015
• Completion Date: 18-Sep-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-33:2010/A2:2015 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Relations

• Amends: EN 60601-2-33:2010 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DPDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR
'RSROQLOR$
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical diagnosis
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik
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
Ta slovenski standard je istoveten z: EN 60601-2-33:2010/A2:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-33:2010/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2015
ICS 11.040.55
English Version
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/A2:2015)
Appareils électromédicaux - Partie 2-33: Exigences Medizinische elektrische Geräte - Teil 2-33: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à résonance magnétique utilisés wesentlichen Leistungsmerkmale von
pour le diagnostic medical Magnetresonanzgeräten für die medizinische Diagnostik
(IEC 60601-2-33:2010/A2:2015) (IEC 60601-2-33:2010/A2:2015)
This amendment A2 modifies the European Standard EN 60601-2-33:2010; it was approved by CENELEC on 2015-07-23. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-33:2010/A2:2015 E

European foreword
The text of document 62B/977/FDIS, future IEC 60601-2-33:2010/A2 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 approved by CENELEC as EN 60601-2-33:2010/A2:2015.

The following dates are fixed:
(dop) 2016-04-23
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-07-23
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-33:2010/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-33:2010/A2:2015 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard
indicated:
IEC 62570:2014 NOTE Harmonized as EN 62570:2015 (not modified).
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Annex ZA of EN 60601-2-33:2010 applies, except as follows:

Publication Year Title EN/HD Year
Replace the existing reference to IEC 60601-1-2:2007 by the following:
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2015
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
Addition:
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
+A1 2013 Part 1-6: General requirements for basic +A1 2015
safety and essential performance -
Collateral standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements + corr. March 2010
+A1 2012 for basic safety and essential performance +A1 2013
- Collateral Standard: General +A1/AC 2014
requirements, tests and guidance for alarm
systems in medical electrical equipment
and medical electrical systems

IEC 60601-2-33 ®
Edition 3.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AM ENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential performance

of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à résonance magnétique utilisés pour le diagnostic

médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-2700-8

– 2 – IEC 60601-2-33:2010/AMD2:2015
© IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic 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/977/FDIS 62B/987/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 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.
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.
_____________
INTRODUCTION TO AMENDMENT 2
This Amendment 2 has been developed to increase the FIRST LEVEL CONTROLLED OPERATING
MODE limit for the static field from 4 T to 8 T taking into account FDA, ICNIRP and other peer
reviewed scientific literature. In addition, a non-compulsory option, FIXED PARAMETER
OPTION:BASIC (FPO:B), is introduced to limit RF and gradient field outputs (peak and RMS) for
scanning PATIENTS with MR conditional implants. Consequently, text is proposed for the
Instructions for use to guide users in scanning PATIENTS with MR conditional implants.
Furthermore, references to newly published collateral standards have been updated.
201.1.3 Collateral standards
Replace, in the first sentence of the second paragraph, the reference to "IEC 60601-1-2:2007"
with "IEC 60601-1-2:2014”.
201.2 Normative references
Replace, under “Replacement”, the reference to "IEC 60601-1-2:2007" with the following:

IEC 60601-2-33:2010/AMD2:2015 – 3 –
© IEC 2015
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
Add, under “Replacement”, the following new references:
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006/AMD1:2012
201.3 Terms and definitions
* 201.3.201
B rms
1+
Delete, in the first line of the definition, “the MR relevant radiofrequency magnetic induction”.
Replace, in the last line of the definition, “evaluation time” with “integration time”.
Replace, in the last line of the definition “, and is estimated at the RF transmit coil centre”
with “, which shall be any 10 s period over the duration of the entire sequence”
Add the following new note to entry:
Note 1 to entry: B is derived from the flip angle averaged over an adjustment volume, which is typically
1+
represented by the axial central slab wherein MR signal is generated.
201.3.203
CONTROLLED ACCESS AREA
Replace the existing text of the definition with the following:
area around the MR SYSTEM, to which access is controlled to prevent HARM from the magnetic
field
Note 1 to entry: The CONTROLLED ACCESS AREA is not identical to the SPECIAL ENVIRONMENT or SPECIAL LOCATION
as defined in IEC 60601-1-2:2014.
201.3.234
TIME RATE OF CHANGE OF THE MAGNETIC FIELD
dB/dt
Add, at the end of the definition, the following note to entry:
Note 1 to entry: The time rate of change of the magnetic field dB/dt is assumed to be evaluated in a suitably low
frequency range (e.g. < 5 kHz) to disregard effects of switching amplifier ripple.
Add the following new terms:
201.3.242
FIXED PARAMETER OPTION
FPO
option within existing modes (i.e. NORMAL OPERATING MODE or FIRST LEVEL CONTROLLED
OPERATING MODE), which specifies a set of operational limit values for the allowable RF field
and GRADIENT OUTPUT and the specified B of the MR EQUIPMENT in a MR EXAMINATION
– 4 – IEC 60601-2-33:2010/AMD2:2015
© IEC 2015
201.3.243
FIXED PARAMETER OPTION:BASIC
FPO:B
“basic” denotes a specific implementation of FPO, exclusively for 1,5 T MR SYSTEMS
Note 1 to entry: The note to entry in French concerning the source of the abbreviation “FPO:B” concerns the French
text only.
201.3.244
B
1+
component of the RF field in the rotating frame that is effective for tilting of the nuclear
magnetization
201.3.245
B PEAK
1+
peak amplitude of B
1+
* 201.3.246
(|dB/dt| PEAK)
FPO
maximum time rate of change of the magnitude of the magnetic field during the MR
EXAMINATION, evaluated at the location defined for FPO, i.e. a surface providing 5 cm clearance
to the outline of the PATIENT accessible volume
* 201.3.247
(|dB/dt| RMS)
FPO
root mean square (rms) of the magnitude of the time rate of change of the magnetic field for
FPO
t
x dB
FPO
dt
| |
( )
∫
dB
dt
(| | RMS) =
FPO
dt t
x
Where t is time, and t is the integration time. dB /dt is a conservative model estimate of
x FPO
the magnetic field associated with the switching gradients
201.3.248
SLEW PERCENTAGE
fraction of time that any gradient is slewing at any rate
201.3.249
CIRCULARLY POLARIZED RF
RF excitation where the two principal electromagnetic modes of the VOLUME RF TRANSMIT COIL
are driven with equal amplitude and 90° phase difference
Note 1 to entry: This drive operation is denoted as “CP” on user interfaces and in ACCOMPANYING DOCUMENTS.
Note 2 to entry: Circularly polarized RF is also commonly referred to as quadrature drive
* 201.3.250
SPATIAL FIELD GRADIENT
SFG

∇B
spatial rate of change of the main magnetic field , expressed in [T/m]
Note 1 to entry: Attractive magnetic forces on magnetisable or saturated ferromagnetic objects scale linearly with
SFG.
IEC 60601-2-33:2010/AMD2:2015 – 5 –
© IEC 2015
Note 2 to entry: The note to entry
...