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    ASTM F2503-23e1

    Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    • 발행일 : 2023-04-01
    • 발행기관 : ASTM
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상세정보

분야 13.02 : 긴급 의료 서비스; 수색 및 구조
적용범위

1.1?This 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.

1.2?The 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.

1.3?MR 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).

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

1.5?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.

1.6?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.
국제분류(ICS)코드 11.040.01 : 일반 의료장비
페이지수 15
Edition 23e1

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F2503-23e1상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2023-04-01 표준
2 ASTM F2503-23상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2023-04-01 구판
3 ASTM F2503-23 REDLINE상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2023-04-01 구판
4 ASTM F2503-20상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2020-02-01 구판
5 ASTM F2503-20 REDLINE상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2020-02-01 구판
6 ASTM F2503-13 REDLINE상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2013-06-01 구판
7 ASTM F2503-13상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2013-06-01 구판
8 ASTM F2503-08상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2008-10-01 구판
9 ASTM F2503-05상세보기 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 2005-08-01 구판

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