Utilize este identificador para referenciar este registo: https://hdl.handle.net/10316/113402
Título: 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
Autor: Bikson, Marom
Ganho-Ávila, Ana 
Datta, Abhishek
Gillick, Bernadette
Joensson, Morten Goertz
Kim, Sungjin
Kim, Jinuk
Kirton, Adam
Lee, Kiwon
Marjenin, Timothy
Onarheim, Balder
Rehn, Erik M
Sack, Alexander T
Unal, Gozde
Data: 2023
Editora: Elsevier
Título da revista, periódico, livro ou evento: Brain Stimulation
Volume: 16
Número: 3
Resumo: 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.
URI: https://hdl.handle.net/10316/113402
ISSN: 1935861X
DOI: 10.1016/j.brs.2023.05.008
Direitos: openAccess
Aparece nas coleções:FPCEUC - Artigos em Revistas Internacionais
I&D CINEICC - Artigos em Revistas Internacionais

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