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Scope

1.1 This practice covers the marking of medical devices and other items to indicate their safety in the magnetic resonance (MR) environment.

1.2 The purpose of this practice is to (1) recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed, and (2) recommend information that should be included in the marking. It is recognized that direct marking on the item is not practical for implants and certain other medical devices. Where direct marking is not practical, this practice recommends that the marking be included in the labeling and on patient information cards (see 7.1).

1.3 Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).

1.4 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.

Significance and Use

Medical devices and other items have caused serious injuries and death for patients and other individuals in the MR environment.

This practice provides a uniform system for marking to indicate the MR conditions that have been determined to be acceptable for a medical device or other item. 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 environment.

Keywords

magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety; ICS Number Code 11.040.01 (Medical equipment in general)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.01 (Medical equipment in general)

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