ASTM F2503-23
(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 items with the MR environment have resulted in serious injuries and death of patients and other individuals. This practice lists hazards that may be present in the MR environment. It specifies marking of items anticipated to enter the MR environment and recommends information that should be included in the associated labeling.
4.2 This practice provides a uniform system of visual icons and terms for marking items for use in the MR environment.
SCOPE
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
Note 1: “Medical devices and other items” will be referred to as “items” for the remainder of this practice.
1.2 The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
1.3 MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination (see X1.12).
1.4 The values stated in SI units are to be regarded as 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2503 − 23
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.
2
1. Scope 2.2 ASTM Standards:
F2052 Test Method for Measurement of Magnetically In-
1.1 This practice applies to medical devices and other items
duced Displacement Force on Medical Devices in the
that are anticipated to enter the magnetic resonance (MR)
Magnetic Resonance Environment
environment.
F2119 Test Method for Evaluation of MR Image Artifacts
3
NOTE 1—“Medical devices and other items” will be referred to as
from Passive Implants (Withdrawn 2022)
“items” for the remainder of this practice.
F2182 Test Method for Measurement of Radio Frequency
1.2 The practice specifies the marking of items anticipated
Induced Heating On or Near Passive Implants During
to enter the MR environment by means of terms and icons, and
Magnetic Resonance Imaging
recommends information that should be included in the label-
F2213 Test Method for Measurement of Magnetically In-
ing.
duced Torque on Medical Devices in the Magnetic Reso-
nance Environment
1.3 MR image artifacts are not in the scope of the manda-
2.3 Other Standards and Documents:
tory portions of this practice because they do not present a
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33:
direct safety issue resulting from specific characteristics of the
Particular Requirements for the Basic Safety and Essential
MR examination (see X1.12).
Performance of Magnetic Resonance Equipment for
1.4 The values stated in SI units are to be regarded as
4
Medical Diagnosis
standard.
ISO 14971 Medical Devices—Application of Risk Manage-
5
1.5 This standard does not purport to address all of the
ment to Medical Devices
safety concerns, if any, associated with its use. It is the
ISO/IEC Guide 51 Safety Aspects—Guidelines for their
5
responsibility of the user of this standard to establish appro-
Inclusion in Standards
priate safety, health, and environmental practices and deter-
ISO TS 10974 Assessment of the Safety of Magnetic Reso-
mine the applicability of regulatory limitations prior to use.
nance Imaging for Patients with an Active Implantable
5
1.6 This international standard was developed in accor-
Medical Device
dance with internationally recognized principles on standard-
3. Terminology
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3.1 Definitions:
mendations issued by the World Trade Organization Technical
3.1.1 active item—an item that serves its functions with the
Barriers to Trade (TBT) Committee.
supply of electrical power (definition modified from Test
Method F2213, passive implant).
2. Referenced Documents
3.1.2 cylindrical MR system—MR system with a substan-
2.1 The following referenced documents are indispensable
tially cylindrical patient aperture, and a static magnetic field
for the application of this practice. For dated references, only
(B ) aligned with the long axis of the cylinder. IEC 60601-2-33
0
the edition cited applies. For undated references, the latest
edition of the referenced document (including any amend-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ments) applies.
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.
1 3
This practice is under the jurisdiction of ASTM Committee F04 on Medical and The last approved version of this historical standard is referenced on
Surgical Materials and Devices and is the direct responsibility of Subcommittee www.astm.org.
4
F04.15 on Material Test Methods. Available from International Electrotechnical Commission (IEC), 3, rue de
Current edition approved April 1, 2023. Published May 2023. Originally Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
5
approved in 2005. Last previous edition approved in 2020 as F2503 – 20. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2503-23. 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
---------------------- Page: 1 ----------------------
F2503 − 23
3.1.2.1 Discussi
...
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 − 20 F2503 − 23
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 international standard applies to the practice of marking of items that might be used inpractice applies to medical devices
and other items that are anticipated to enter the magnetic resonance (MR) environment.
NOTE 1—“Medical devices and other items” will be referred to as “items” for the remainder of this practice.
1.2 The purpose of this practice is to mark items that might be brought into practice specifies the marking of items anticipated
to enter the MR environment and to recommend by means of terms and icons, and recommends information that should be included
in the marking.labeling.
1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons.
1.3 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice
in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific
characteristics of the MR examination (see X1.5X1.12).
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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 The following referenced documents are indispensable for the application of this document.practice. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 Feb. 1, 2020April 1, 2023. Published February 2020May 2023. Originally approved in 2005. Last previous edition approved in 20132020 as
F2503F2503 – 20.–13. DOI: 10.1520/F2503-20.10.1520/F2503-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2503 − 23
2
2.2 ASTM Standards:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
3
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)
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:Standards and Documents:
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety Basic Safety and Essential
4
Performance of Magnetic Resonance Equipment for Medical Diagnosis
5
ISO 14971 Medical Devices—Application of Risk Management to Medical Devices
5
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
5
Device
3. Terminology
3.1 Definitions:
3.1.1 active item—an item that serves its functions with the supply of electrical power (definition modified from Test Method
F2213, passive implant).
3.1.2 harmful interaction—cylindrical MR system—unintended direct or indirect interaction of items with MR equipment,
especially with the static magnetic
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2503 − 23
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.
2
1. Scope 2.2 ASTM Standards:
F2052 Test Method for Measurement of Magnetically In-
1.1 This practice applies to medical devices and other items
duced Displacement Force on Medical Devices in the
that are anticipated to enter the magnetic resonance (MR)
Magnetic Resonance Environment
environment.
F2119 Test Method for Evaluation of MR Image Artifacts
3
NOTE 1—“Medical devices and other items” will be referred to as
from Passive Implants (Withdrawn 2022)
“items” for the remainder of this practice.
F2182 Test Method for Measurement of Radio Frequency
1.2 The practice specifies the marking of items anticipated
Induced Heating On or Near Passive Implants During
to enter the MR environment by means of terms and icons, and
Magnetic Resonance Imaging
recommends information that should be included in the label-
F2213 Test Method for Measurement of Magnetically In-
ing.
duced Torque on Medical Devices in the Magnetic Reso-
nance Environment
1.3 MR image artifacts are not in the scope of the manda-
2.3 Other Standards and Documents:
tory portions of this practice because they do not present a
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33:
direct safety issue resulting from specific characteristics of the
Particular Requirements for the Basic Safety and Essential
MR examination (see X1.12).
Performance of Magnetic Resonance Equipment for
1.4 The values stated in SI units are to be regarded as
4
Medical Diagnosis
standard.
ISO 14971 Medical Devices—Application of Risk Manage-
5
1.5 This standard does not purport to address all of the
ment to Medical Devices
safety concerns, if any, associated with its use. It is the
ISO/IEC Guide 51 Safety Aspects—Guidelines for their
5
responsibility of the user of this standard to establish appro-
Inclusion in Standards
priate safety, health, and environmental practices and deter-
ISO TS 10974 Assessment of the Safety of Magnetic Reso-
mine the applicability of regulatory limitations prior to use.
nance Imaging for Patients with an Active Implantable
5
1.6 This international standard was developed in accor-
Medical Device
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 3. Terminology
Development of International Standards, Guides and Recom-
3.1 Definitions:
mendations issued by the World Trade Organization Technical
3.1.1 active item—an item that serves its functions with the
Barriers to Trade (TBT) Committee.
supply of electrical power (definition modified from Test
Method F2213, passive implant).
2. Referenced Documents
3.1.2 cylindrical MR system—MR system with a substan-
2.1 The following referenced documents are indispensable
tially cylindrical patient aperture, and a static magnetic field
for the application of this practice. For dated references, only
(B ) aligned with the long axis of the cylinder. IEC 60601-2-33
0
the edition cited applies. For undated references, the latest
edition of the referenced document (including any amend-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ments) applies.
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.
1 3
This practice is under the jurisdiction of ASTM Committee F04 on Medical and The last approved version of this historical standard is referenced on
Surgical Materials and Devices and is the direct responsibility of Subcommittee www.astm.org.
4
F04.15 on Material Test Methods. Available from International Electrotechnical Commission (IEC), 3, rue de
Current edition approved April 1, 2023. Published May 2023. Originally Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
5
approved in 2005. Last previous edition approved in 2020 as F2503 – 20. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2503-23. 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
---------------------- Page: 1 ----------------------
F2503 − 23
3.1.2.1 Discussion—This is inclusive of elliptical patient which an item might pose a hazard from exposure to the
aperture systems. electromagnetic fields produced by
...
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