IEC 60601-2-33:2010/AMD2:2015

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
IEC 60601-2-33:2010-03/AMD2:2015-06(en-fr)

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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• withdrawn,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 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 2015
Note 2 to entry: The note to entry in French concerning the source of the abbreviation “SFG” concerns the French
text only.
Table 201.101 – List of symbols
Replace the existing title with the following:
Table 201.101 – List of symbols and abbreviations
201.7 ME EQUIPMENT identification, marking and documents
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.13 Physiological effects (safety signs and warning statements)
Replace, in the first sentence of the first paragraph, ”ISO 7010-W005 and ISO 7010-W006”
with ”ISO 7010-W005 (see Table 201.D.101, safety sign 1) and ISO 7010-W006 (see Table
201.D.101, safety sign 2)”
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
* 201.7.9.2.101 Instructions for use for MR EQUIPMENT
* d) Exposure of the PATIENT and MR WORKER to excessive acoustic noise
Add, at the end of the only sentence in Note 1, ”(see Table 201.D.101, safety sign 6)”
* f) Liquid and gaseous cryogens
Add, between the first and second bullet points under the last dash, the following new note:
NOTE Applicable safety signs ISO 7010-M004 (see Table 201.D.101, safety sign 7) and ISO 7010-M009 (see
Table 201.D.101, safety sign 8) are appropriate for placement near the locati
...