ASTM F2503-23 PDF

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.

ASTM F2503-23 Referenced Document

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*， 2024-04-21 Update
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
ISO 14971 Medical devices - Application of risk management to medical devices

2023 ASTM F2503-23e1 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2023 ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2020 ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2013 ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2008 ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2005 ASTM F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment