SIST EN 62570:2015

SLOVENSKI STANDARD
SIST EN 62570:2015
01-september-2015
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SUHGPHWRY]QRWUDMQDG]RURYDQHJDREPRþMD
Magnetic resonance equipment for medical imaging - Instructions for marking items
within the controlled access area
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer
Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen
Appareils à résonance magnétique utilisés pour l'imagerie médicale - Instructions pour le
marquage des éléments à l'intérieur de la zone à accès contrôlé
Ta slovenski standard je istoveten z: EN 62570:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 62570:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62570:2015

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SIST EN 62570:2015


EUROPEAN STANDARD EN 62570

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.50; 11.040.55

English Version
Standard practice for marking medical devices and other items
for safety in the magnetic resonance environment
(IEC 62570:2014)
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 62570:2014) (IEC 62570:2014)
This European Standard was approved by CENELEC on 2015-04-14. 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, 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 62570:2015 E

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SIST EN 62570:2015
EN 62570:2015
Foreword
The text of document 62B/933/FDIS, future edition 1 of IEC 62570, 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 62570:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national 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(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 62570:2014 was approved by CENELEC as a European
Standard without any modification.
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SIST EN 62570:2015
EN 62570:2015
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.

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 On or
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 2010 Medical electrical equipment - EN 60601-2-33 2010
Part 2-33: Particular requirements for the
- - + corrigendum Oct. 2010
basic safety and essential performance of
magnetic resonance equipment for medical
- - + A11 2011
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

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SIST EN 62570:2015
EN 62570:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
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SIST EN 62570:2015




IEC 62570

®


Edition 1.0 2014-02




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Standard practice for marking medical devices and other items for safety in the

magnetic resonance environment




Pratiques normalisées relatives au marquage des appareils médicaux et des

éléments de sûreté divers dédiés aux environnements de résonance

magnétique















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX Q


ICS 11.040.50; 11.040.55 ISBN 978-2-8322-1443-5



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 62570:2015
CONTENTS

FOREWORD . 3
1 Scope . 5
2 Referenced Documents . 5
3 Terminology . 6
4 Significance and Use . 7
5 Requirements for assessment of potential hazards caused by interactions of an item
and the MR Environment . 7
6 Methods of Marking. 7
7 Information Included in MR Marking . 8
8 Keywords . 10
APPENDIX . 13
X1. RATIONALE . 13


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SIST EN 62570:2015
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62570, integrating the unmodified text of ASTM F2503 - 13, has been
developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62:
Medical equipment in medical practice, in collaboration with ASTM.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/933/FDIS 62B/934/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
The committee has decided that the contents of this 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
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SIST EN 62570:2015
• 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 publication using a colour printer.


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SIST EN 62570:2015
F2503 - 13
Standard Practice for
Marking Medical Devices and Other Items for Safety in the Magnetic
1
Resonance Environment
This standard is issued under the fixed designation F2503 - 13; 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 (ε) indicates an editorial change since the last revision or
reapproval.

1. Scope
1.1 This international standard applies to the practice of marking of items that might be used in the magnetic
resonance (MR) environment.
1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to
recommend information that should be included in the marking.
1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of
terms and icons.
1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international
standard practice (see X1.5).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in
this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the
responsibility of the user of his standard to establish appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
2. Referenced Documents
2.1 The following referenced documents are indispensable for the application 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.
2
2.2 ASTM Standards:
   F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment
   F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
   F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging
   F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic
Resonance Environment
2.3 Other Standards:
   IEC 60601-2-33 Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic
4
Resonance Equipment for Medical Diagnosis
   ISO 14971 Medical Devices — Application of Risk 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


1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct
responsibility of Subcommittee F04.15 on Material Test Methods.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2005. Last previous edition approved in 2005 as
F2503 – 05. DOI: 10.1520/F2503 - 08.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For
Annual Book of ASTM Standards volume information, refer to the standard's Document Summary page on the ASTM website.
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SIST EN 62570:2015
F2503 - 13
3. Terminology
3.1 Definitions:
3.1.1 harmful interaction— unintended direct or indirect interaction of items with MR equipment,
especially with the static magnetic field, the gradient fields and the RF fields of the MR equipment, that
can pose hazards to patients or other persons.
NOTE 1- In this context, the affected image quality or image artifacts are not considered to be a harmful
interaction.

3.1.2 hazard—potential source of harm. [ISO/IEC Guide 51]
3.1.3 item—object that might be brought into the MR environment.
3.1.4 magnetically induced displacement force—force produced when a magnetic object is exposed to the spatial
gradient of a static magnetic field. This force will tend to cause the object to translate in the spatial gradient of the
static magnetic field.
3.1.5 magnetically induced torque—torque produced when a magnetic object is exposed to a magnetic field. This
torque will tend to cause the object to align itself along the magnetic field in an equilibrium direction that induces no
torque.
3.1.6 magnetic induction or magnetic flux density (B in T)—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force experienced by an element of electric current at the point,
or by the electromotive force induced in an elementary loop during any change in flux linkages with the loop at the
point. The magnetic induction is frequently referred to as the magnetic field. B is the static field in an MR
0
equipment and accessories. Plain type indicates a scalar (for example, B) and bold type indicates a vector (for
example, B).
3.1.7 magnetic resonance (MR)—resonant absorption of electromagnetic energy by an ensemble of
atomic nuclei situated in a magnetic field. IEC 60601-2-33, definition 201.3.217
3.1.8 magnetic resonance (MR) equipment—medical electrical equipment which is intended for in vivo
magnetic resonance examination of a patient comprising all parts in hardware and software from the
supply mains to the display monitor.
NOTE 2- The MR equipment is a programmable electrical medical system (PEMS) IEC 60601-2-33,
definition 201.3.218
3.1.9 magnetic resonance (MR) examination—process of acquiring data by magnetic resonance from a
patient IEC 60601-2-33, definition 201.3.219
3.1.10 magnetic resonance (MR) environment—the three dimensional volume of space surrounding the MR
magnet that contains both the Faraday shielded volume and the 0.50 mT field contour (5 gauss (G) line). This
volume is the region in which an item might pose a hazard from exposure to the electromagnetic fields produced by
the MR equipment and accessories.
3.1.11 MR Conditional–an item with demonstrated safety in the MR environment within defined conditions. At a
minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and the
radiofrequency fields. Additional conditions, including specific configurations of the item, may be required.
3.1.12 Supplementary Marking—additional information that, in association with a marking as “MR Conditional,”
states via additional language the conditions in which an item can be used safely within the MR environment.
3.1.13 MR Safe—an item that poses no known hazards resulting from exposure to any MR environment. MR
Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic
Note 3- An item composed entirely of electrically nonconductive, nonmetallic and nonmagnetic materials may be
determined to be MR Safe by providing a scientifically based rationale rather than test data. Examples of MR Safe items are
a cotton blanket or a silicone catheter.
3.1.14 MR Unsafe—an item which poses unacceptable risks to the patient, medical staff or other persons within
the MR environment.
NOTE 4— ISO 14971 Medical devices - Application of risk management to medical devices, includes a process for evaluating
risks, including identifying unacceptable risks. MR Unsafe items include items such as a pair of ferromagnetic scissors.
3.1.15 medical device—any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or
calibrator, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific purpose(s) of:
(1) diagnosis, prevention, monitoring, treatment, or alleviation of disease;
(2) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
(3) investigation, replacement, modification, or support of the anatomy or of a physiological process;
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SIST EN 62570:2015
F2503 - 13
(4) supporting or sustaining life;
(5) control of conception;
(6) disinfection of medical devices;
(7) providing information for medical purposes by means of in vitro examination of specimens derived from the
human body, and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological, or metabolic means, but which may be assisted in its function by such means. [ISO 13485]
3.1.16 radio frequency (RF) magnetic field—the magnetic field in MRI that is used to flip the magnetic moments.
The frequency of the RF field is γB where γ is the gyromagnetic constant, 42.56 MHz/T for protons, and B is the
0 0
static magnetic field in Tesla.
3.1.17 safety—freedom from unacceptable risk.
3.1.18 specific absorption rate (SAR)—radio frequency power absorbed per unit of mass (W/kg). [IEC
60601-2-33]
4
3.1.19 tesla, (T)—the SI unit of magnetic induction equal to 10 gauss (G).
4. Significance and Use
4.1 Interactions of medical devices and other items with the MR environment has resulted in serious injuries and
death of patients and other individuals. Additionally, hazards stemming from equipment malfunction are of concern.
Section 4.2 lists possible direct and indirect causes of hazards in the MR environment.
4.2 Potential direct and indirect causes of hazards
4.2.1 Direct causes:
4.2.1.1 mechanical causes, including magnetically induced displacement force, torque, and vibration
4.2.1.2 electromagnetic causes, including induction (heating, stimulation) and discharge (spark gap)
4.2.1.3 acoustic causes
4.2.2 Indirect causes:
4.2.2 malfunction of items, for example of vital components such as valves, monitors and pumps
4.3 This practice provides a uniform system for marking to indicate the conditions for which it has been
determined that a medical device or other item may be safely placed and used in the MR environment. It provides
simple visual icons and terms which are intended to reduce injuries and other mishaps that occur when items that
pose hazards in the MR environment are brought into the MR environment.
5. Requirements for assessment of potential hazards caused by interactions of an item and the MR
Environment

5.1 Perform testing sufficient to characterize the behavior of the item in the MR environment.
5.1.1 In particular, testing for items that may be placed in the MR environment should address magnetically
induced displacement force (Test Method F2052), magnetically induced torque (Test Method F2213), and RF
heating (Test Method F2182 for passive implants and ISO TS 10974 for active implants).  Additionally, electronic
components shall be evaluated for malfunction.
5.1.2 Other possible safety issues to consider for the hazard assessment include, but are not limited to, thermal
injury, induced currents/voltages, interaction with the switched gradient field, dB/dt, for all items that may go inside
the magnet bore, electromagnetic compatibility, neurostimulation, acoustic noise, interaction among devices, and the
malfunction of the item and the malfunction of the MR equipment and accessories. See Table X.1.1 for some
hazards and associated test methods. Also see Section X1.2.1.4.
5.2 List any parameter that affects the safety of the item. Describe any condition that is known to produce an
unsafe condition.
NOTE 5 - These remarks do not claim to be complete. Therefore it is recommended that the user of this standard consider specific questions and
topics that may be applicable to the specific item being evaluated. Some potential hazards to patients and others in the MR environment are given
in X1.2.1 and Table X1.1.
6. Methods of Marking
6.1 The marking method shall not compromise performance or function of the marked item and should provide
legibility over the anticipated service life of the item. For all items external to the body of a person for which it is
technically feasible, labeling for MR Conditional items shall appear on the item and include the conditions for safety
in the MR environment.
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SIST EN 62570:2015
F2503 - 13
7. Information Included in MR Marking
7.1 Medical devices and other items vary widely in size, and the amount of information that practically can be
included in marking varies accordingly.  For implants, the MR marking shall be included in the labeling (including
the instructions for use, package inserts, patient and physician manuals) and on the patient information card. Non-
implanted items, where feasible, shall have MR marking on the item as well as in the labeling. Some items (for
example, small or very thin ones) do not provide any surfaces which can be marked practically. For items for which
direct marking is not practical, the MR marking shall be included in the labeling. For both implants and non-
implanted items, the MR marking may be placed on the product packaging label (e.g. on the box), however the
package label should clearly indicate the item(s) inside the packaging to which the MR marking applies (e.g.,
implant only or implant and delivery system).

7.2 The marking method shall not compromise performance or function of the marked item and should remain
readable over the anticipated service life of the item.
7.3 Minimum Information—As a result of the testing described in Section 5, mark the item as MR Safe, MR
Conditional, or MR Unsafe using the icons as shown in Tables 1 and 2.
7.3.1 The MR Safe icon consists of the letters “MR” surrounded by a green square (Table 1 and Figures 1 and 2).
Two options are given. When color reproduction is not practical, the icon may be printed in black and white (Table 2
and Figures 3 and 4). The use of the colored icon is strongly encouraged for the added visibility and information
provided by the color. For both color and black and white options in Tables 1 and 2, the option that is most visible
for the individual application should be chosen.
7.3.2 The MR Conditional icon consists of the letters “MR” within a yellow equilateral triangle with a thick black
band around the perimeter (Table 1 and Figure 5). The triangle is oriented with its horizontal side below the letters
“MR.” When color reproduction is not practical, the icon may be printed in black and white (Table 2 and Figure 6).
The use of the colored icon is strongly encouraged for the added visibility and information provided by the color.
7.3.2.1 For MR Conditional items, the item labeling (instructions for use, package inserts, operator manual,
patient information card, patient and physician information pamphlets, as appropriate) shall include appropriate
information from Section 5. (1) The MR Conditional icon may be supplemented by supplementary marking which
includes the appropriate information from Section 5 and describes the conditions for which
...