OUTPUT LEVELS AND BIOEFFECTS INDEXES FROM DIAGNOSTIC ULTRASOUND EXPOSURE DATA REPORTED TO THE FDA
OUTPUT LEVELS AND BIOEFFECTS INDEXES FROM DIAGNOSTIC ULTRASOUND EXPOSURE DATA REPORTED TO THE FDA
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DOI：
10.1109/58.285470
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发表时间：
1994-05-01
影响因子：
3.6
通讯作者：
PHILLIPS, RA
中科院分区：
文献类型：
--
作者：
PATTON, CA;HARRIS, GR;PHILLIPS, RA
作为联邦食品、药品和化妆品法案 1976 年医疗器械修正案第 510(k) 条要求的一部分，诊断超声设备的制造商向美国食品和药物管理局提交声学输出数据。由于此信息与评估超声暴露引起的任何潜在生物效应有关，因此我们总结了 1990 年和 1991 年期间处理的测量数据。总结了实时 B 型和 M 型、一般脉冲多普勒、外周血管 (PV) 脉冲多普勒和彩色血流多普勒的暴露数据。暴露量包括峰值稀疏和压缩压力、空间峰值脉冲平均和空间峰值时间平均强度（水和降额值）以及功率。此外，在数据允许的情况下，还计算了机械指数和热指数。对暴露数量和指数的范围、平均值、中位数和标准差进行了分类。一般来说，多普勒模式下的时间平均值（包括指数）高于 B/M 成像模式。尽管 PV 和彩色血流多普勒类别的值往往较高，但时间峰值暴露量和指数之间的差异不太明显。这些数据以及其他人收集的可比结果提供了一种将当前设备的输出与超声波引起的生物效应相关的暴露水平联系起来的方法。
As part of the Section 510(k) requirements of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, manufacturers of diagnostic ultrasound devices submit acoustic output data to the U.S. Food and Drug Administration. Because this information is pertinent to the assessment of any potential bioeffects due to ultrasound exposure, we have summarized the measurement data processed during 1990 and 1991. Exposure data were summarized for real-time B-mode and M-mode, general pulsed Doppler, peripheral vascular (PV) pulsed Doppler, and color flow Doppler. Exposure quantities included peak rarefactional and compressional pressures, spatial-peak pulse-average and spatial-peak temporal-average intensities (both water and derated values), and power. Also, where data permitted, mechanical and thermal indices were calculated. Ranges, means, medians, and standard deviations were categorized for the exposure quantities and indices. In general the temporal-average values (including indices) were higher in Doppler modes than in B/M imaging modes. Differences among the temporal-peak exposure quantities and indices were less distinct, although values tended to be higher in the PV and color flow Doppler categories. These data, along with comparable results collected by others, provide a means to relate the output of current devices to levels of exposure relevant to ultrasound-induced biological effects.