A case study: Re-evaluating the biological risk following a processing aid change on a marketed cardiovascular implant device

Per ISO 10993-1:2018, a processing change to a medical device requires re-evaluation of biological risk. Here, we present the biological evaluation of a marketed cardiovascular implant following a detergent formulation change. This change was initially assessed through a qualitative toxicological ri...

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Principais autores:	Frances K. Hsia, Alessia Stornetta, Nicole V. Soucy
Formato:	Artigo
Idioma:	Inglês
Publicado em:	Frontiers Media S.A. 2022-11-01
Colecção:	Frontiers in Medical Technology
Assuntos:	medical device biological risk evaluation toxicological risk assessment extractable leachable threshold of toxicological concern
Acesso em linha:	https://www.frontiersin.org/articles/10.3389/fmedt.2022.1006984/full
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