Biocompatibility Ratings

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.