Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.
PMID: 42815842 ·
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抄録
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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