Kobayashi Kyo, Dong Ruhong, Nicolalde Roberto Javier, Williams Benjamin B, Du Gaixin, Swartz Harold M, Flood Ann Barry
EPR Center for the Study of Viable Systems, Radiology Department, Geisel School of Medicine at Dartmouth, HB 7785, Williamson Translational Research Bldg. Lebanon, NH, USA.
Nicolalde R&D, LLC, West Lebanon, NH, USA.
Radiat Prot Dosimetry. 2016 Dec;172(1-3):152-160. doi: 10.1093/rpd/ncw215. Epub 2016 Aug 22.
Testing and verification are an integral part of any cycle to design, manufacture and improve a novel device intended for use in humans. In the case of testing Dartmouth's electron paramagnetic resonance (EPR) in vivo tooth dosimetry device, in vitro studies are needed throughout its development to test its performance, i.e. to verify its current capability for assessing dose in individuals potentially exposed to ionizing radiation. Since the EPR device uses the enamel of human teeth to assess dose, models that include human teeth have been an integral mechanism to carry out in vitro studies during development and testing its ability to meet performance standards for its ultimate intended in vivo use. As the instrument improves over time, new demands for in vitro studies change as well. This paper describes the tooth models used to perform in vitro studies and their evolution to meet the changing demands for testing in vivo EPR tooth dosimetry.
测试和验证是设计、制造和改进用于人体的新型设备的任何周期中不可或缺的一部分。在测试达特茅斯体内电子顺磁共振（EPR）牙齿剂量测定设备时，在其整个开发过程中都需要进行体外研究以测试其性能，即验证其当前评估潜在暴露于电离辐射的个体剂量的能力。由于EPR设备使用人类牙齿的牙釉质来评估剂量，因此包含人类牙齿的模型一直是在开发过程中进行体外研究以及测试其满足最终体内使用性能标准能力的不可或缺的机制。随着仪器随时间改进，对体外研究的新需求也会发生变化。本文描述了用于进行体外研究的牙齿模型及其演变，以满足体内EPR牙齿剂量测定测试不断变化的需求。
