Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.
Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.
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DOI：
10.1016/j.brs.2023.05.008
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发表时间：
2023-05
影响因子：
7.7
通讯作者：
Unal, Gozde
中科院分区：
文献类型：
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作者：
Bikson, Marom;Ganho- Avila, Ana;Datta, Abhishek;Joensson, Morten Goertz;Gillick, Bernadette;Kim, Sungjin;Kim, Jinuk;Kirton, Adam;Lee, Kiwon;Marjenin, Timothy;Onarheim, Balder;Rehn, Erik M.;Sack, Alexander T.;Unal, Gozde
本 2023 年有限输出经颅电刺激 (LOTES-2023) 指南的目标和范围是更新之前的 LOTES-2017 指南。因此，这些文件应该一起考虑。 LOTES 为设备设计提供了清晰明确且透明的框架，为各种预期用途提供有限输出（指定低强度范围）经颅电刺激。这些指南可以为试验设计和监管决策提供信息，但最直接地为制造商活动提供信息 - 因此在 LOTES-2017 中作为“合规性受控有限输出 tES 设备的自愿行业标准”提出。在 LOTES-2023 中，我们强调这些标准在很大程度上与国际标准和国家法规（包括美国、欧盟和韩国的标准）保持一致，因此可以更好地理解为“合规性受控有限输出 tES 设备的行业标准”。因此，LOTES-2023 进行了更新，以反映新兴国际标准以及最佳可用科学证据之间的共识。 “警告”和“注意事项”已更新，以符合当前的生物医学证据和应用。 LOTES 标准适用于有限的设备剂量范围，但在此剂量范围内和针对不同的使用案例，制造商有责任进行特定于设备的风险管理。
The objective and scope of this Limited Output Transcranial Electrical Stimulation 2023 (LOTES-2023) guidance is to update the previous LOTES-2017 guidance. These documents should therefore be considered together. The LOTES provides a clearly articulated and transparent framework for the design of devices providing limited output (specified low-intensity range) transcranial electrical stimulation for a variety of intended uses. These guidelines can inform trial design and regulatory decisions, but most directly inform manufacturer activities - and hence were presented in LOTES-2017 as “Voluntary industry standard for compliance controlled limited output tES devices”. In LOTES-2023 we emphasize that these standards are largely aligned across international standards and national regulations (including those in USA, EU, and South Korea), and so might be better understood as “Industry standards for compliance controlled limited output tES devices”. LOTES-2023 is therefore updated to reflect a consensus among emerging international standards, as well as best available scientific evidence. “Warnings” and “Precautions” are updated to align with current biomedical evidence and applications. LOTES standards applied to a constrained device dose range, but within this dose range and for different use-cases, manufacturers are responsible to conduct device-specific risk management.
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DOI：
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发表时间：
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期刊：
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