Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 8-528
Standard
ASTM  F2503-20
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Scope/Abstract
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).
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2503-20 [Rec# 8-528] will be superseded by recognition of ASTM F2503-23 [Rec# 8-602]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-528] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-528] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 801 Labeing, medical devices, reporting and recordkeeping requirements.
21 CFR Part 809 Labeling, medical devices.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Issued December 2014.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
-
-