ASTM International - ASTM F2503-13

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

inactive

Organization:	ASTM International
Publication Date:	1 June 2013
Status:	inactive
Page Count:	9
ICS Code (Medical equipment in general):	11.040.01

significance And Use:

4.1 Interactions of medical devices and other items with the MR environment has resulted in serious injuries and death of patients and other individuals. Additionally, hazards stemming from... View More

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 and health practices and determine the applicability of regulatory limitations prior to use.