IEC 62570:2014

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.

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.

General Information

• Status: Published
• Publication Date: 25-Feb-2014
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 45 - TC 62/SC 62B/WG 45
• Current Stage: PPUB - Publication issued
• Start Date: 28-Feb-2014
• Completion Date: 26-Feb-2014

Standards Content (Sample)

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

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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
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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
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the specific publication. At this date, the publication will be
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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 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 amen
...