ASTM F2503-13
(Practice)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
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:
4.2.2.1 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.
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 this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F2503 − 13
Standard Practice for
Marking Medical Devices and Other Items for Safety in the
1
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.
1. Scope Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts
1.1 This international standard applies to the practice of
from Passive Implants
marking of items that might be used in the magnetic resonance
F2182 Test Method for Measurement of Radio Frequency
(MR) environment.
Induced Heating On or Near Passive Implants During
1.2 The purpose of this practice is to mark items that might
Magnetic Resonance Imaging
be brought into the MR environment and to recommend
F2213 Test Method for Measurement of Magnetically In-
information that should be included in the marking.
duced Torque on Medical Devices in the Magnetic Reso-
1.3 The standard specifies the permanent marking of items, nance Environment
which are used in an MR environment, by means of terms and
2.3 Other Standards:
icons.
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33:
Particular Requirements for the Safety of Magnetic Reso-
1.4 MR image artifacts are not considered to be a perfor-
3
mance issue and so are not addressed in this international nance Equipment for Medical Diagnosis
ISO 14971 Medical Devices—Application of Risk Manage-
standard practice (see X1.5).
4
ment to Medical Devices
1.5 The values stated in SI units are to be regarded as
ISO/IEC Guide 51 Safety Aspects—Guidelines for their
standard. No other units of measurement are included in this
4
Inclusion in Standards
standard.
ISO TS 10974 Assessment of the Safety of Magnetic Reso-
1.6 This standard does not purport to address all of the
nance Imaging for Patients with an Active Implantable
safety concerns, if any, associated with its use. It is the 4
Medical Device
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3. Terminology
bility of regulatory limitations prior to use.
3.1 Definitions:
2. Referenced Documents
3.1.1 harmful interaction—unintended direct or indirect in-
teraction of items with MR equipment, especially with the
2.1 The following referenced documents are indispensable
static magnetic field, the gradient fields and the RF fields of the
for the application of this document. For dated references, only
MR equipment, that can pose hazards to patients or other
the edition cited applies. For undated references, the latest
persons.
edition of the referenced document (including any amend-
ments) applies.
NOTE 1—In this context, the affected image quality or image artifacts
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are not considered to be a harmful interaction.
2.2 ASTM Standards:
3.1.2 hazard—potential source of harm. ISO/IEC Guide 51
F2052 Test Method for Measurement of Magnetically In-
duced Displacement Force on Medical Devices in the
3.1.3 item—object that might be brought into the MR
environment.
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ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3.1.4 magnetically induced displacement force—force pro-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
ducedwhenamagneticobjectisexposedtothespatialgradient
F04.15 on Material Test Methods.
CurrenteditionapprovedJune1,2013.PublishedJuly2013.Originallyapproved
in2005.Lastpreviouseditionapprovedin2008asF2503–08.DOI:10.1520/F2503-
13.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Electrotechnical Commission (IEC), 3, rue de
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2503 − 13
of a static magnetic field. This force will tend to cause the 3.1.14 MR Unsafe—an item which poses unacceptable risks
object to translate in the spatial gradient of the static magnetic to the patient, medical staff or other persons within the MR
field. environment.
3.1.5 magnetically induced torque—torque produced when
NOTE 4—ISO 14971 Medical devices–Application of risk management
a magnetic object is exposed to a magnetic field. This tor
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2503 − 08 F2503 − 13
Standard Practice for
Marking Medical Devices and Other Items for Safety in the
1
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.
1. Scope
1.1 This practice covers the marking of medical devices and other items to indicate their safetyinternational 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 (1)mark recommend that items that maymight be brought into the MR environment be
permanently marked to indicate the MR environment to which a specific item may safely be exposed, and (2)to recommend
information that should be included in the marking. It is recognized that direct marking on the item is not practical for implants
and certain other medical devices. Where direct marking is not practical, this practice recommends that the marking be included
in the labeling and on patient information cards (see 7.1).
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 Image artifact is MR image artifacts are not considered to be a safetyperformance issue and so isare 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 this 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.
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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:
ISO 3864-1:2002(E)IEC 60601-2-33 Graphical Symbols—Safety Colours and Safety Signs—Part 1: Design Principles for
Safety Signs in Workplaces and Public AreasMedical Electrical Equipment—Part 2-33: Particular Requirements for the Safety
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of Magnetic Resonance Equipment for Medical Diagnosis
ISO 13485:2003(E)ISO 14971 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes,
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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, 2008June 1, 2013. Published November 2008July 2013. Originally approved in 2005. Last previous edition approved in 20052008 as
F2503 – 05.F2503–08. DOI: 10.1520/F2503-08.10.1520/F2503-13.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.International Electrotechnical Commission (IEC), 3, rue
de Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2503 − 13
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definition 3.7Devices—Application of Risk Management to Medical Devices
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ISO/IEC Guide 51 Guide 51:1999, definition 3.5Safety Aspects—Guidelines for their Inclusion in Standards
IEC 60601-2-33, Ed. 2.0ISO TS 10974 Medical Electrical Equipment—Part 2: Particular Requirements f
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