SIST EN IEC 62570:2026
(Main)Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2025)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2025)
IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen (IEC 62570:2025)
Pratiques normalisées relatives au marquage des appareils médicaux et des éléments de sûreté divers dédiés aux environnements de résonance magnétique (IEC 62570:2025)
L'IEC 62570:2025 s'applique aux appareils médicaux et éléments divers qui sont présumés entrer dans l'environnement de résonance magnétique (RM).
Ce document spécifie le marquage des éléments présumés entrer dans l'environnement de RM à l'aide de termes et d'icônes, et recommande les informations qu'il convient d'intégrer à l'étiquetage.
Les artefacts d'image à RM ne relèvent pas du domaine d'application des parties obligatoires de cette pratique, car ils ne constituent pas un problème de sécurité résultant directement des caractéristiques spécifiques de l'examen par RM.
Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov za varno uporabo v okolju magnetne resonance (IEC 62570:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2026
Nadomešča:
SIST EN 62570:2015
Standardna praksa za označevanje medicinskih pripomočkov in drugih predmetov
za varno uporabo v okolju magnetne resonance (IEC 62570:2025)
Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment (IEC 62570:2025)
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer
Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen (IEC
62570:2025)
Pratiques normalisées relatives au marquage des appareils médicaux et des éléments
de sûreté divers dédiés aux environnements de résonance magnétique (IEC
62570:2025)
Ta slovenski standard je istoveten z: EN IEC 62570:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
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 62570
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2025
ICS 11.040.50; 11.040.55 Supersedes EN 62570:2015
English Version
Standard practice for marking medical devices and other items
for safety in the magnetic resonance environment
(IEC 62570:2025)
Pratiques normalisées relatives au marquage des appareils Standardverfahren für die Kennzeichnung medizinischer
médicaux et des éléments de sûreté divers dédiés aux Geräte und anderer Gegenstände zur Sicherheit in der
environnements de résonance magnétique Umgebung von Magnetresonanzeinrichtungen
(IEC 62570:2025) (IEC 62570:2025)
This European Standard was approved by CENELEC on 2025-10-23. 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
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62570:2025 E
European foreword
The text of document 62B/1381/CDV, future edition 2 of IEC 62570, 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) 2026-11-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-11-30
document have to be withdrawn
This document supersedes EN 62570:2015 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 62570:2025 was approved by CENELEC as a European
Standard without any modification.
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.
Publication Year Title EN/HD Year
ASTM F2052 - Standard Test Method for Measurement of - -
Magnetically Induced Displacement Force
on Medical Devices in the Magnetic
Resonance Environment
ASTM F2119 - Standard Test Method for Evaluation of - -
MR Image Artifacts from Passive Implants
ASTM F2182 - Standard Test Method for Measurement of - -
Radio Frequency Induced Heating Near
Passive Implants During Magnetic
Resonance Imaging
ASTM F2213 - Standard Test Method for Measurement of - -
Magnetically Induced Torque on Medical
Devices in the Magnetic Resonance
Environment
IEC 60601-2-33 - Medical electrical equipment - Part 2-33: EN IEC 60601-2-33 -
Particular requirements for the basic safety
and essential performance of magnetic
resonance equipment for medical
diagnosis
ISO 14971 - Medical devices - Application of risk EN ISO 14971 -
management to medical devices
ISO/IEC Guide 51 - Safety aspects - Guidelines for their - -
inclusion in standards
ISO/TS 10974 - Assessment of the safety of magnetic - -
resonance imaging for patients with an
active implantable medical device
IEC 62570 ®
Edition 2.0 2025-09
INTERNATIONAL
STANDARD
Standard practice for marking medical devices and other items for safety in the
magnetic resonance environment
ICS 11.040.50; 11.040.55 ISBN 978-2-8327-0717-3
IEC 62570:2025-09(en)
,(& ‹,(&
CONTENTS
Foreword . 2
1 Scope . 4
2 Referenced documents . 4
3 Terminology . 4
4 Significance and use . 5
5 Hazards pertaining to items entering the MR environment . 6
6 MR marking . 6
7 Keywords . 9
Appendix. 9
,(& ‹,(&
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Standard practice for marking medical devices and other items for safety
in the magnetic resonance environment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 62570 has been prepared by subcommittee 62B: Medical imaging equipment, software,
and systems, of IEC technical committee 62: Medical equipment, software, and systems. It is
an International Standard.
It is based on ASTM F2503-23 and was submitted as a Fast-Track document.
The text of this International Standard is based on the following documents:
Draft Report on voting
%//&'9 %//RV&
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
,(& ‹,(&
The structure and editorial rules used in this publication reflect the practice of the organization
which submitted it.
This document was developed in accordance with ISO/IEC Directives, Part 1 and ISO/IEC
Directives, IEC Supplement, available at www.iec.ch/members_experts/refdocs. The main
document types developed by IEC are described in greater detail at www.iec.ch/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
x reconfirmed,
x withdrawn, or
x revised.
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
,(& ‹,(&
´1
Designation: F2503 −23
Standard Practice for
Marking Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment
This standard is issued under the fixed designation F2503; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—References in 6.3.3 were editorially corrected in October 2023.
1. Scope the edition cited applies. For undated references, the latest
edition of the referenced document (including any amend-
1.1 This practice applies to medical devices and other items
ments) applies.
that are anticipated to enter the magnetic resonance (MR)
2.2 ASTM Standards:
environment.
F2052 Test Method for Measurement of Magnetically In-
NOTE 1—“Medical devices and other items” will be referred to as
duced Displacement Force on Medical Devices in the
“items” for the remainder of this pract
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.