Biocompatibility Ratings: external_communicating#blood_contacting
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| external_communicating#blood_contacting | limited_lt_24hr | yes | no | no | blood_contacting | yes | no | external_communicating | yes | yes | no | yes | arterial catheters (single use), vascular access catheters, blood sample syringes | no | yes | no | no |
| external_communicating#blood_contacting | limited_lt_24hr_carcinogenicity_note | no | no | no | blood_contacting | no | no | external_communicating | no | no | no | no | Note: carcinogenicity (ISO 10993-3) typically waived for limited-contact blood-path devices via genotoxicity negative result plus risk assessment; required if leachable profiles indicate carcinogenic potential | no | no | no | no |
| external_communicating#blood_contacting | permanent_gt_30d | yes | yes | yes | blood_contacting | yes | yes | external_communicating | yes | yes | no | yes | ventricular assist device blood-contacting surfaces, chronic arteriovenous shunts | yes | yes | yes | yes |
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