ASTM F2503-23e1

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

ASTM International , 04/01/2023

Publisher: ASTM

File Format: PDF

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Description

Standard By:ASTM International , 04/01/2023

Published:04/01/2023

Pages:15

File Size:1 file , 710 KB

Language:English

Note:This product is unavailable in Russia, Ukraine, Belarus

1.1This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.

Note 1:"Medical devices and other items" will be referred to as "items" for the remainder of this practice.

1.2The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.

1.3MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination (see X1.12).

1.4The values stated in SI units are to be regarded as standard.

1.5This 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.

1.6This 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.

ASTM F2503-23e1

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

ASTM F2503-23e1 History

ASTM F2503-23e1

ASTM F2503-20

ASTM F2503-08

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