ASTM F2503-08
(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
Medical devices and other items have caused serious injuries and death for patients and other individuals in the MR environment.
This practice provides a uniform system for marking to indicate the MR conditions that have been determined to be acceptable for a medical device or other item. 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
p id="s00002">1.1 This practice covers the marking of medical devices and other items to indicate their safety in the magnetic resonance (MR) environment.
1.2 The purpose of this practice is to (1) recommend that items that may 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) 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 Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 − 08
StandardPractice 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 from Passive Implants
F2182 Test Method for Measurement of Radio Frequency
1.1 This practice covers the marking of medical devices and
Induced Heating On or Near Passive Implants During
other items to indicate their safety in the magnetic resonance
Magnetic Resonance Imaging
(MR) environment.
F2213 Test Method for Measurement of Magnetically In-
1.2 The purpose of this practice is to (1) recommend that
duced Torque on Medical Devices in the Magnetic Reso-
items that may be brought into the MR environment be
nance Environment
permanently marked to indicate the MR environment to which
2.2 Other Standards:
a specific item may safely be exposed, and (2) recommend
ISO 3864-1:2002(E) Graphical Symbols—Safety Colours
information that should be included in the marking. It is
and Safety Signs—Part 1: Design Principles for Safety
recognized that direct marking on the item is not practical for 3
Signs in Workplaces and Public Areas
implants and certain other medical devices. Where direct
ISO 13485:2003(E) Medical Devices—Quality Manage-
marking is not practical, this practice recommends that the
ment Systems—Requirements for Regulatory Purposes,
3
marking be included in the labeling and on patient information
definition 3.7
cards (see 7.1). 4
ISO/IEC Guide 51:1999, definition 3.5
IEC 60601-2-33, Ed. 2.0 Medical Electrical Equipment—
1.3 Image artifact is not considered to be a safety issue and
so is not addressed in this practice (see X1.5). Part2:ParticularRequirementsfortheSafetyofMagnetic
4
Resonance Equipment for Medical Diagnosis
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard.
3.1 Definitions:
1.5 This standard does not purport to address all of the
3.1.1 hazard—potential source of harm. ISO/IEC Guide 51
safety concerns, if any, associated with its use. It is the
3.1.2 item—medical device or other object that may be
responsibility of the user of this standard to establish appro-
brought into the MR environment.
priate safety and health practices and determine the applica-
3.1.3 magnetically induced displacement force— force pro-
bility of regulatory limitations prior to use.
ducedwhenamagneticobjectisexposedtothespatialgradient
2. Referenced Documents of a static magnetic field. This force will tend to cause the
2
object to translate in the spatial gradient of the static magnetic
2.1 ASTM Standards:
field.
F2052 Test Method for Measurement of Magnetically In-
duced Displacement Force on Medical Devices in the 3.1.4 magnetically induced torque—torque produced when
a magnetic object is exposed to a magnetic field. This torque
Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts will tend to cause the object to align itself along the magnetic
field in an equilibrium direction that induces no torque.
3.1.5 magnetic induction or magnetic flux density (B in
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
T)—that magnetic vector quantity which at any point in a
Surgical Materials and Devices and is the direct responsibility of Subcommittee
magnetic field is measured either by the mechanical force
F04.15 on Material Test Methods.
experiencedbyanelementofelectriccurrentatthepoint,orby
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 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036.
4
Standards volume information, refer to the standard’s Document Summary page on Available from International Electrotechnical Commission (IEC), 3 rue de
the ASTM website. Varembé, Case postale 131, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2503 − 08
the electromotive force induced in an elementary loop during 3.1.13 radio frequency (RF) magnetic field—the magnetic
any change in flux linkages with the loop at the point. The field in MRI that is used to flip the magnetic m
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2503–05 Designation:F2503–08
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 F 2503; 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 safety in the magnetic resonance (MR)
environment.
1.2 The purpose of this practice is to (1) recommend that items that may 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) 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 Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).
1.4
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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
2.1 ASTM Standards:
F 2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
F 2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F 2182 TestMethodforMeasurementofRadioFrequencyInducedHeatingNearPassiveImplantsDuringMagneticResonance
Imaging
F 2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
2.2 Other Standards:
ISO 3864-1:2002(E) Graphical Symbols—Safety Colours and Safety Signs—Part 1: Design Principles for Safety Signs in
3
Workplaces and Public Areas
3
ISO 13485:2003(E) Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes, definition 3.7
4
ISO/IEC Guide 51:1999, definition 3.5
IEC 60601-2-33, Ed. 2.0 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Magnetic Resonance
4
Equipment for Medical Diagnosis
3. Terminology
3.1 Definitions:
3.1.1 hazard—potential source of harm. ISO/IEC Guide 51
3.1.2 item—medical device or other object that may be brought into the MR environment.
3.1.3 magnetically induced displacement force— force produced when a magnetic object is exposed to the spatial gradient of
1
This practice is under the jurisdiction ofASTM 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 Aug. 1, 2005. Published August 2005.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2005. Last previous edition approved in 2005 as F 2503 – 05.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
4
Available from International Electrotechnical Commission (IEC), 3 rue de Varembé, Case postale 131, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2503–08
a static magnetic field. This force will tend to cause the object to translate in the spatial gradient of the static magnetic field.
3.1.4 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.
3.1.5 magnetic induction or magnetic flux density (B in T)—that magnetic vector quantity which at any point in
...
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