EN 62570:2015
(Main)Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. 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. The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice. IEC 62570 is integrating the unmodified text of ASTM F2503-13. It has been developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM.
Standardverfahren für die Kennzeichnung medizinischer Geräte und anderer Gegenstände zur Sicherheit in der Umgebung von Magnetresonanzeinrichtungen
Pratiques normalisées relatives au marquage des appareils médicaux et des éléments de sûreté divers dédiés aux environnements de résonance magnétique
L'IEC 62570:2014 s'applique aux pratiques de marquage des éléments qui pourraient être utilisés dans des environnements de résonance magnétique (RM). L'objectif de cette pratique est de marquer les éléments qui peuvent ne pas être installés dans un environnement de RM, mais aussi d'indiquer les informations qu'il convient d'intégrer au marquage. La norme spécifie le marquage permanent des éléments utilisés dans un environnement de RM via des termes et symboles. Les artefacts d'image à RM ne constituent pas un problème de performance et ne sont donc pas abordés dans cette pratique internationale normalisée. Les valeurs indiquées dans des unités SI doivent être considérées comme normalisées. Aucune autre unité de mesure n'est utilisée dans cette norme. L'IEC 62570 comprend le texte non modifié de la ASTM F2503-13. Elle a été établie par le sous-comité 62B: Appareils d'imagerie de diagnostic, du comité d'études 62 de l'IEC: Equipements électriques dans la pratique médicale, en collaboration avec la ASTM.
Oprema z magnetno resonanco za medicinsko slikanje - Navodila za označevanje predmetov znotraj nadzorovanega območja
Ta standard se nanaša na prakso označevanja predmetov, ki bi se lahko uporabljali v okolju magnetne resonance (MR). Namen te prakse je označevanje predmetov, ki bi se lahko vnesli v okolje MR, in priporočiti informacije, ki bi jih bilo smiselno vključiti v oznako. Standard določa trajno označevanje predmetov, ki se uporabljajo v okolju MR, in sicer z izrazi in ikonami. Artefakti pri slikah v okviru MR se ne štejejo za težavo pri delovanju, zato niso obravnavani v praksi tega mednarodnega standarda (glej točko X1.5). Vrednosti, podane v enotah SI, se štejejo za standard. V tem standardu niso vključene druge merilne enote. Ta standard ne obravnava vseh morebitnih varnostnih težav, ki se nanašajo na njegovo uporabo. Za vzpostavitev ustreznih varnostnih in zdravstvenih praks ter za določitev uporabnosti regulativnih omejitev pred uporabo je odgovoren uporabnik tega standarda.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
2SUHPD]PDJQHWQRUHVRQDQFR]DPHGLFLQVNRVOLNDQMH1DYRGLOD]DR]QDþHYDQMH
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
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
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.
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
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
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,
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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.
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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
• 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.
F2503 - 13
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 - 13; the number immediately following the designatio
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