Biocompatibility Ratings: surface_device#breached_surface

ISO 10993-1:2018 biological evaluation requirements for medical devices. For each combination of device category (surface_device, external_communicating, implant), contact type (skin, mucosal_membrane, breached_surface, tissue_bone, blood_path_indirect, blood_contacting, tissue_bone_implant, blood_implant), and contact duration (limited_lt_24hr, prolonged_24hr_to_30d, permanent_gt_30d), specifies which biocompatibility tests are required per ISO 10993-1:2018 Table A.1 and FDA Guidance (September 2020). Test endpoints include cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute/subchronic/chronic toxicity, genotoxicity, implantation, hemocompatibility, carcinogenicity, reproductive toxicity, and degradation. Supplementary note records document key footnotes and risk-based exceptions from ISO 10993-1:2018 Annex A.

Materials Sciencebiocompat_key: surface_device#breached_surface3 rows

biocompat key	contact duration	acute systemic toxicity required	carcinogenicity required	chronic toxicity required	contact type	cytotoxicity required	degradation required	device category	genotoxicity required	hemocompatibility required	implantation required	irritation required	material examples	reproductive toxicity required	sensitization required	subacute toxicity required	subchronic toxicity required
surface_device#breached_surface	limited_lt_24hr	yes	no	no	breached_surface	yes	no	surface_device	no	no	no	yes	wound-contact layers of burn dressings, post-surgical adhesive drapes	no	yes	no	no
surface_device#breached_surface	permanent_gt_30d	yes	yes	yes	breached_surface	yes	no	surface_device	yes	no	no	yes	skin substitutes/grafts, permanent wound-care devices	yes	yes	yes	yes
surface_device#breached_surface	prolonged_24hr_to_30d	yes	no	no	breached_surface	yes	no	surface_device	yes	no	no	yes	burn dressings (extended), ulcer wound fillers, haemostatic agents	no	yes	yes	no

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Biocompatibility Ratings: surface_device#breached_surface

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