Fed Regist. 2005 Jun 10;70(111):33997-4042.
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
美国食品药品监督管理局（FDA）正在发布一项最终规则，以修订诊断X射线系统及其主要部件的联邦性能标准（性能标准）。该机构采取这一行动是为了更新性能标准，以适应射线照相和荧光透视X射线系统技术和使用方面的变化，并在性能标准中充分利用国际单位制来描述与辐射相关的量及其单位。为清晰易懂起见，FDA正在重新发布性能标准法规三个部分经修订后的完整内容，并对第四部分进行修订但不全文重新发布。此行动是根据经1990年《安全医疗器械法案》（SMDA）修订的《联邦食品、药品和化妆品法案》（该法案）采取的。
