Biocompatibility Ratings: implant#tissue_bone_implant
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.
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| implant#tissue_bone_implant | limited_lt_24hr | yes | no | no | tissue_bone_implant | yes | no | implant | no | no | yes | yes | temporary surgical sponges, short-term intraperitoneal lavage devices | no | yes | no | no |
| implant#tissue_bone_implant | permanent_gt_30d | yes | yes | yes | tissue_bone_implant | yes | yes | implant | yes | no | yes | yes | orthopaedic bone plates, screws, hip stems, knee components, spinal cages, dental implants | yes | yes | yes | yes |
| implant#tissue_bone_implant | permanent_gt_30d_degradation_note | no | no | no | tissue_bone_implant | no | no | implant | no | no | no | no | Note: degradation evaluation (ISO 10993-9/13/14/15) required for resorbable polymers (PLA/PGA/PCL), bioresorbable ceramics (TCP/HA), and metals (Mg alloys) when leachables/degradation products are anticipated | no | no | no | no |
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