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References from Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states. Local targets link to admitted publications; unresolved targets remain external evidence.
Foreign body reaction to biomaterials
10.1016/j.smim.2007.11.004 · 2008 · External reference
Material-mediated pyrogens in medical devices: myth or reality?
2026 · External reference
Development of a novel low-background noise blood loop model for testing blood-contacting biomaterials and medical devices in fresh human blood
10.1002/jbm.b.35130 · 2023 · External reference
Unresolved reference
2026 · External reference
Regulation (EU) 2017/745 of 5 April 2017 on medical devices
2017 · External reference
Use of international standard ISO 10993-1, "Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process"
2023 · External reference
Unresolved reference
2026 · External reference
Report on investigation of ISO 10993-12 extraction conditions
10.1016/j.yrtph.2022.105164 · 2022 · External reference
A case study: re-evaluating the biological risk following a processing aid change on a marketed cardiovascular implant device
10.3389/fmedt.2022.1006984 · 2022 · External reference
Unresolved reference
2017 · External reference
Unresolved reference
2017 · External reference
Unresolved reference
2018 · External reference
Unresolved reference
2019 · External reference
Unresolved reference
2019 · External reference
ISO 10993-18:2020, biological evaluation of medical devices - part 18: chemical characterization of medical device materials within a risk management process
2020 · External reference
ISO 10993-12:2021, biological evaluation of medical devices - part 12: sample preparation and reference materials
2021 · External reference
Unresolved reference
2021 · External reference
Unresolved reference
2023 · External reference
Unresolved reference
2025 · External reference
Unresolved reference
2026 · External reference
Genotoxicity evaluation of medical devices: a regulatory perspective
10.1016/j.mrrev.2021.108407 · 2022 · External reference
Strategy on biological evaluation for biodegradable/absorbable materials and medical devices
2018 · External reference
In vitro hemocompatibility testing of medical devices
10.1016/j.thromres.2020.07.027 · 2020 · External reference
Biocompatibility of resorbable polymers: a historical perspective and framework for the future
10.1021/acs.biomac.9b00159 · 2019 · External reference
Taring the scales: Weight-of-evidence framework for biocompatibility evaluations
10.1016/j.yrtph.2024.105590 · 2024 · External reference
Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?
10.1016/j.yrtph.2024.105622 · 2024 · External reference
Chemical characterization and non-targeted analysis of medical device extracts: a review of current approaches, gaps, and emerging practices
10.1021/acsbiomaterials.1c01119 · 2022 · External reference
Chemical characterization in medical device evaluation: current practices, regulatory requirements, and future directions
10.1007/s10439-025-03702-5 · 2025 · External reference
Blood-contacting biomaterials: in vitro evaluation of the hemocompatibility
10.3389/fbioe.2018.00099 · 2018 · External reference
Compositional profiling for biodegradable medical devices: a framework for degradation-informed exposure and risk assessment
10.3389/ftox.2026.1766769 · 2026 · External reference
