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Normas ASTM – AENOR
ASTM F2503-20

ASTM F2503-20

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

Fecha:
2020-03-04 /Active
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 equipment malfunction are of concern. Section 4.2 lists possible direct and indirect causes of hazards in the MR 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, torque, and vibration

4.2.1.2 electromagnetic causes, including induction (heating, stimulation) and discharge (spark gap)

4.2.1.3 acoustic causes

4.2.2 Indirect causes:

4.2.2.1 malfunction of items, for example of 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 be 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 environment.

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.

Keywords:
magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety;
43,7
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