1.1 该测试方法表征了被动植入物（在没有供电或外部电源的情况下工作的植入物）在磁共振（MR）图像中产生的失真和信号损失伪影。不包括任何未确定为MR安全或MR有条件的情况。 1.2 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.3 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 该测试方法提供了在一组标准扫描条件下产生的图像伪影的量化测量。 5.2 此测试方法仅适用于已确定为MR安全或MR条件的被动植入物。

1.1 This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or external power). Anything not established to be MR-Safe or MR-Conditional is excluded. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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. ====== Significance And Use ====== 5.1 This test method provides a quantified measure of the image artifact produced under a standard set of scanning conditions. 5.2 This test method applies only to passive implants that have been established to be MR-Safe or MR-Conditional.