Biocompatibility Ratings: implant#blood_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#blood_implant | limited_lt_24hr | yes | no | no | blood_implant | yes | no | implant | yes | yes | yes | yes | temporary intravascular devices (diagnostic), aortic punch biopsy devices | no | yes | no | no |
| implant#blood_implant | permanent_gt_30d | yes | yes | yes | blood_implant | yes | yes | implant | yes | yes | yes | yes | coronary stents, aortic stent-grafts, heart valve prostheses, pacemaker leads, VAD impellers | yes | yes | yes | yes |
| implant#blood_implant | permanent_gt_30d_pyrogen_note | no | no | no | blood_implant | no | no | implant | no | no | no | no | Note: pyrogen/endotoxin testing (ISO 10993-11; ISO 10993-25 for pyrogenicity) and sterility/bioburden evaluation (ISO 11135/11137) always required for implantable blood-contacting devices even though not explicitly listed in Table A.1 | no | no | no | no |
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