Biological-Safety-by-Design for Bioresorbable Intravascular Drug-Delivery Implants: Operationalizing ISO 10993-1:2025 Across Device, Degradation, and Payload States.
PMID: 42815842 ·
Anna Fleischer, Johannes Braig, Tomasz Jüngst, Valentin Schwer, Heinz Schwer, Oliver Schöffski
JournalRegulatory toxicology and pharmacology : RTP
Year
PMID42815842
Abstract
Bioresorbable intravascular drug-delivery implants do not present a fixed biological test article: materials, surfaces, payload exposure, degradation products, particles, and tissue interactions evolve from deployment through resorption. ISO 10993-1:2025 strengthens lifecycle- and risk-management-based biological evaluation, but operationalization for such systems is complicated by time-dependent material change and asynchronous European Union and United States implementation. We reviewed curren
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