ASTM F2503-20
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Standard No.
ASTM F2503-20
Release Date
2020
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM F2503-23
Latest
ASTM F2503-23e1
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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 F2503-20 Referenced Document

  • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*2021-10-01 Update
  • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants*2024-04-20 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

ASTM F2503-20 history

  • 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
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment



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