Toxic or not toxic? The specifications of the standard ISO 10993-5 are not explicit enough to yield comparable results in the cytotoxicity assessment of an identical medical device

BackgroundMedical device manufacturers are obliged to prove the biocompatibility of their products when they come into contact with the human body. The requirements for the biological evaluation of medical devices are specified by the international standard series ISO 10993. Part five of this series...

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Bibliographic Details
Main Authors: Sarah Gruber, Angela Nickel
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-06-01
Series:Frontiers in Medical Technology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmedt.2023.1195529/full