ASTM F2503:20 pdf download

ASTM F2503:20 pdf download.Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
4.2 Potential direct and indirect causes of hazards:
4.2.1 Direct causes:
4.2.1.1 mechanical causes. including magnetically induced displacement force, Lorque, and vibration
4.2.1.2 eleciromanetic causes, including induction (heating, stimulation) and discharge (spark gap)
4.2.1 .3 acoustic causes
4.2.2 Indirect causes:
4.2.2. 1 mallunction of items. [or example ol vital components such as valves, monitors and pumps
4.3 This practice provides a uniform system for marking to indicate the conditions for which it has been determined that a medical device or other item may he safely placed and used in the MR environment. It provides simple visual icons and terms which are intended to reduce injuries and other mishaps that occur when items that pose hazards in the MR environment are brought into the MR environmenL.
5. Requirements for Assessment of Potential Hazards Caused b’ Interactions of an Item and the MR
Environ in en I
5. 1 Perform testing sutlicient to characterize the behavior ot the item in the MR environment.
5.1.1 In particular, testing for items that may be placed in the MR environment should address magnetically induced displacement force (Test Method F2052), magnetically induced Lorque (Test Method F2213), and RF heating (Test Method F2 182 for passive implants and iSO TS 10974 for active implants). Additionally, electronic components shall be evaluated for nial function.
5.1.2 Other possible safety issues to consider for the hazard assessment include. bUt are not limited to. thermal injury. induced currents/voltages, interaction with the switched gradient field (dB/dt) for all items that may go inside the magnet bore, electromagnetic compatibility. neurostimulation. acoustic noise, interaction among devices, and the malfunction of the item and the malfunction of the MR equipment and accessories. See Table X 1 . I for some hazards and associated test methods. Also see section X 1.2.1 .4.
5.2 List any parameter that aliects the safl.ty of the item. Describe any condition that is known to produce an unsafe condition.
Nmi. I—These remarks do not claim to be complete. Therefore it is recommended that the user of this standard consider specific questions and topics that may be applicable to the specific item being evaluated. Some potential hazards to patients and others in the MR environment are given in X1.2.l and Table XI.l.
6. Methods of Marking
6. 1 The marking method shall not compromise performance or function of the marked item and should provide legibility over the anticipated service life of the item.