SIST EN IEC 60601-2-33:2024

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2022)

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS.
NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2022)

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 60601-2-33:2022)

L'IEC 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
L'IEC 60601-2-33:2022 annule et remplace la troisième édition parue en 2010, l’Amendement 1:2013 et l’Amendement 2:2015. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente:
a) alignement sur l’IEC 60601-1:2005 et ses deux amendements IEC 60601 1:2005/AMD1:2012 et IEC 60601-1:2005/AMD2:2020;
b) ajout d’exigences de sécurité pour l'UNITE DE COUPURE D’URGENCE DU CHAMP;
c) clarification des mesures de protection acoustique pour le PATIENT et le PERSONNEL RM;
d) ajout d’une déclaration d'émission de bruit pour l’exposition à l'intérieur de la SALLE D’EXAMEN PAR RM, afin de soutenir l'évaluation de la santé au travail par L’ORGANISME RESPONSABLE;
e) ajout de méthodes de conformité pour la sécurité thermique des bobines RF;
f) ajout de définitions d’émission RF pour satisfaire aux exigences applicables à l’étiquetage à RM CONDITIONNELLE des DISPOSITIFS MEDICAUX;
g) clarification des exigences applicables à l’étiquetage à RM CONDITIONNELLE des ACCESSOIRES;
h) alignement de la limite de champ magnétique statique pour la zone de DANGER B0 sur les limites dans les autres normes de DISPOSITIFS MEDICAUX (notamment la limite pour les stimulateurs cardiaques, ISO 14117), avec une nouvelle valeur limite de 0,9 mT;
i) meilleure description des tracés relatifs aux champs magnétiques sur la fiche de spécifications techniques de compatibilité (CTSS);
j) la fourniture de séquences de compatibilité (sur la CTSS) pour l’essai de l'appareil auxiliaire par le FABRICANT RM est désormais facultative, et sa suppression est prévue dans une édition future;
k) présence d’une section distincte qui comporte les exigences relatives à un document d’aménagement du site contenant des informations de sécurité;
l) exigences pour la fonction d’avertissement (de PATIENT à OPERATEUR);
m) introduction de la fonctionnalité MROC obligatoire pour les systèmes 1,5 T et 3 T afin de faciliter le balayage des PATIENTs qui portent des DISPOSITIFS MEDICAUX étiquetés comme équipements à RM CONDITIONNELLE, à moins que ce balayage ne fasse l'objet d’une contre-indication explicite du FABRICANT RM;
n) les symboles pour bobines RF dans le Tableau 201.A.102 sont devenus obligatoires, et les signaux variants préférentiels ont été échangés par rapport à l’édition précédente, le signal avec couleur constituant désormais le signal préférentiel;
o) la détermination du champ parasite B₁ en 201.12.4.105.3.3 uniquement par des calculs.

Medicinska električna oprema - 2-33. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za magnetno resonanco za medicinsko diagnostiko (IEC 60601-2-33:2022)

General Information

• Status: Published
• Publication Date: 03-Oct-2024
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Sep-2024
• Due Date: 30-Nov-2024
• Completion Date: 04-Oct-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: EN IEC 60601-2-33:2024 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Relations

• Revised: 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
• Effective Date: 03-Aug-2020
• Revised: SIST 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 (IEC 60601-2-33:2010)
• Effective Date: 03-Aug-2020
• Revised: SIST EN 60601-2-33:2010/A1:2015 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 03-Aug-2020
• Revised: SIST EN 60601-2-33:2010/AC:2016 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 03-Aug-2020
• Revised: SIST EN 60601-2-33:2010/A12:2017 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 03-Aug-2020
• Revised: SIST EN 60601-2-33:2010/A11:2012 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• Effective Date: 03-Aug-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-33. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za magnetno resonanco za medicinsko diagnostiko (IEC
60601-2-33:2022)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical diagnosis (IEC
60601-2-33:2022)
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2022)
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 60601-2-33:2022)
Ta slovenski standard je istoveten z: EN IEC 60601-2-33:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-33

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.040.55 Supersedes EN 60601-2-33:2010/corrigendum Oct. 2010;
EN 60601-2-33:2010; EN 60601-2-33:2010/A11:2011; EN
60601-2-33:2010/A1:2015; EN 60601-2-33:2010/A2:2015;
EN 60601-2-33:2010/A12:2016; EN 60601-2-
33:2010/AC:2016-03
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 60601-2-33:2022)
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 von
essentielles des appareils à résonance magnétique utilisés Magnetresonanzgeräten für die medizinische Diagnostik
pour le diagnostic médical (IEC 60601-2-33:2022)
(IEC 60601-2-33:2022)
This European Standard was approved by CENELEC on 2022-09-08. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-33:2024 E

European foreword
The text of document 62B/1277/FDIS, future edition 4 of IEC 60601-2-33, prepared by SC 62B
"Medical imaging equipment, software, and systems" of IEC/TC 62 "Medical equipment, software, and
systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-03-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-09-20
document have to be withdrawn
This document supersedes EN 60601-2-33:2010 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-33:2022 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1-3 NOTE Approved as EN 60601-1-3
IEC 60601-1-9 NOTE Approved as EN 60601-1-9
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 60601-1-11 NOTE Approved as EN 60601-1-11
IEC 60601-1-12 NOTE Approved as EN 60601-1-12
IEC 62464-1 NOTE Approved as EN IEC 62464-1
IEC 60364-7-710 NOTE Approved as HD 60364-7-710
IEC 60601-2-62:2013 NOTE Approved as EN 60601-2-62:2015 (not modified)
ISO 14630:2012 NOTE Approved as EN ISO 14630:2012 (not modified)
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) +A11:2021
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where 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.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Replace:
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60695-11-10 2013 Fire hazard testing - Part 11-10: Test EN 60695-11-10 2013
flames - 50 W horizontal and vertical flame
test methods
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
IEC 61672-1 2013 Electroacoustics - Sound level meters - EN 61672-1 2013
Part 1: Specifications
IEC 61672-2 2013 Electroacoustics - Sound level meters - EN 61672-2 2013
Part 2: Pattern evaluation tests
IEC 62570 2014 Standard practice for marking medical EN 62570 2015
devices and other items for safety in the
magnetic resonance environment
ISO 3746 2010 Acoustics - Determination of sound power EN ISO 3746 2010
levels and sound energy levels of noise
sources using sound pressure - Survey
method using an enveloping measurement
surface over a reflecting plane
ISO 9614-1 - Acoustics - Determination of sound power EN ISO 9614-1 -
levels of noise sources using sound
intensity - Part 1: Measurement at discrete
points
NEMA MS 4 - Acoustic noise measurement procedure for - -
diagnostic Magnetic Resonance Imaging
(MRI) devices
NEMA MS 8 - Characterization of the specific absorption - -
rate (SAR) for magnetic resonance
imaging systems
NEMA MS 14 - Characterization of radiofrequency (RF) - -
coil heating in magnetic resonance imaging
systems
IEC 60601-2-33 ®
Edition 4.0 2022-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8322-3955-1

IEC 60601-2-33:2022/ISH1:2023 – 1 –
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
IEC 60601-2-33
Edition 4.0  2022-08
MEDICAL ELECTRICAL EQUIPMENT –

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

INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62B: Medical imaging equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62B/1315/DISH 62B/1319/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.

___________
Definition 201.3.214 (EFFECTIVE STIMULUS DURATION t )
s,eff
The definition is clarified by the following:
a) It is important to consider that the magnetic field gradient displayed in Figure 201.101 can
GRADIENT UNITS.
be realized by simultaneous activation of multiple
b) The concept of t applies both to cardiac stimulation and peripheral nerve stimulation.
s,eff
c) The appropriate timescale for evaluating the duration of monotonic increase or decrease of
the GRADIENT OUTPUT is in the order of the chronaxie. When a discrete time-segment based
approach is used for numerical evaluation, one or more discrete time segments deviating
from monotonic increase or decrease will likely not reset t nor modify the likelihood of
s,eff
stimulation. Application of a filter as suggested in Annex AA (Formula AA.22) can prevent
unintentional misinterpretation of monotonicity.
ICS 11.040.55
IEC 60601-2-33:2022-08/ISH1:2023-05(en)

– 2 – IEC 60601-2-33:2022/ISH1:2023
© IEC 2023
Definition 201.3.219 (HEAD SAR)
Note 1 to entry is clarified as follows:
Extent of the head as provided in the note to entry represents a common understanding of
medical professionals. Variation in assessment volume for HEAD SAR is acceptable for use by
the MR MANUFACTURER when implementing IEC 60601-2-33. For example, these volumes could
be (tilted) axial demarcations of cervical vertebrae C3, C5, or C7.

– 2 – IEC 60601-2-33:2022 © IEC 2022
CONTENTS
FOREWORD . 4
* INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 18
201.5 General requirements for testing of ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 36
201.9 Protection against MECHANICAL HAZARDs of ME EQUIPMENT and ME SYSTEMS . 37
201.10 Protection against unwanted and excessive radiation HAZARDS . 39
201.11 Protection against excessive temperatures and other HAZARDS . 39
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 39
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 60
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) . 61
201.15 Construction of ME EQUIPMENT . 61
201.16 ME SYSTEMS . 61
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 62
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests .
...