ASTM F2503 - 23e1
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
| Aviso: | Las normas ASTM en lectura se visualizan a través del área de cliente. Los archivos no se pueden descargar |
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| Fecha edición: |
2023-04-01
Anulada
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| Fecha cancelación: | 2023-04-01 |
| Idiomas disponibles: | Inglés |
| Resumen: | |
| Keywords: | magnet; magnetic; medical devices; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety; |
| Scope: | 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. |
| ICS: | 11.040.01 - Equipo médico en general |
| CTN: | F04.15 - F04.15 |
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Otras Relaciones |
Es referenciada por F2213 - 25 Es referenciada por F1781-21 Es referenciada por F2665-21 Es referenciada por F2052-21 Es referenciada por F2182-19E02 Es referenciada por F3437-23 Es referenciada por F0366-24 Es referenciada por F1541-24 Es referenciada por F0384-24 Es referenciada por F2119-24 Es referenciada por F1264-24 Es referenciada por F3666 - 25 Es referenciada por F1831 - 24 Es referenciada por F3395/F3395M - 24 Es referenciada por F2943 - 25 Es referenciada por F0543-23 Es referenciada por F2978-20 Es referenciada por F2193-20 Es referenciada por F2180-24 Es referenciada por F2502-24 |
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