Biocompatibility Ratings: surface_device#mucosal_membrane
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| surface_device#mucosal_membrane | limited_lt_24hr | no | no | no | mucosal_membrane | yes | no | surface_device | no | no | no | yes | laryngoscope blades, tongue depressors, endoscope (brief contact) | no | yes | no | no |
| surface_device#mucosal_membrane | permanent_gt_30d | yes | yes | yes | mucosal_membrane | yes | no | surface_device | yes | no | no | yes | intrauterine devices (IUD), extended-wear contact lenses, nasal implants | no | yes | no | yes |
| surface_device#mucosal_membrane | prolonged_24hr_to_30d | yes | no | no | mucosal_membrane | yes | no | surface_device | no | no | no | yes | nasal cannula, urinary catheter (short-term), contact lens (daily) | no | yes | no | no |
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