Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states
Fleischer A, Braig J, Jüngst T, Schwer V, Schwer H, Schöffski O (2027)
Publication Type: Journal article, Review article
Publication year: 2027
Journal
Book Volume: 173
Article Number: 106265
DOI: 10.1016/j.yrtph.2026.106265
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 current ISO standards, European Union and US Food and Drug Administration sources, and peer-reviewed literature through September 2026 and propose a biological-safety-by-design framework structured as State-Exposure-Hazard-Evidence-Control (SEHEC). Seven device states, including a degradation-profile-defined mid-degradation state, are linked to four exposure compartments and to chemical, blood-interaction, local-tissue, particulate, systemic, and payload-related hazards. SEHEC uses question-specific representative worst cases, explicit rules for leveraging prior evidence across platform configurations, and predefined change triggers for materials, processing, sterilization, geometry, payload, packaging, and intended use. Applied to ENDOLEASE as a non-clinical boundary case, the framework produces a device-state sequence, exposure model, evidence-gap register, and change-impact logic without making a safety, performance, or regulatory-classification claim. The approach may help manufacturers separate a common scientific evidence core from jurisdiction-specific implementation while keeping biological evaluation approaches responsive to changing device and degradation states.
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Germany (DE)How to cite
APA:
Fleischer, A., Braig, J., Jüngst, T., Schwer, V., Schwer, H., & Schöffski, O. (2027). Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states. Regulatory Toxicology and Pharmacology, 173. https://doi.org/10.1016/j.yrtph.2026.106265
MLA:
Fleischer, Anna, et al. "Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states." Regulatory Toxicology and Pharmacology 173 (2027).
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