Biocompatibility Ratings: external_communicating#blood_path_indirect

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: external_communicating#blood_path_indirect3 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
external_communicating#blood_path_indirect	limited_lt_24hr	yes	no	no	blood_path_indirect	yes	no	external_communicating	no	yes	no	yes	solution administration sets, IV tubing, blood-collecting tubes	no	yes	no	no
external_communicating#blood_path_indirect	permanent_gt_30d	yes	yes	yes	blood_path_indirect	yes	no	external_communicating	yes	yes	no	yes	permanent central venous catheters, implantable ports, long-term haemodialysis components	yes	yes	yes	yes
external_communicating#blood_path_indirect	prolonged_24hr_to_30d	yes	no	no	blood_path_indirect	yes	no	external_communicating	yes	yes	no	yes	IV infusion sets (multi-day), enteral feeding tubes, short-term haemodialysis lines	no	yes	yes	no

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Biocompatibility Ratings: external_communicating#blood_path_indirect

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