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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Frontiers Media S.A.
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9742234/ https://www.ncbi.nlm.nih.gov/pubmed/36518990 http://dx.doi.org/10.3389/fmedt.2022.1006984 |