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

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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Bibliographic Details
Main Authors: Frances K. Hsia, Alessia Stornetta, Nicole V. Soucy
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-11-01
Series:Frontiers in Medical Technology
Subjects:
medical device
biological risk evaluation
toxicological risk assessment
extractable
leachable
threshold of toxicological concern
Online Access:https://www.frontiersin.org/articles/10.3389/fmedt.2022.1006984/full

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https://www.frontiersin.org/articles/10.3389/fmedt.2022.1006984/full

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