Sub-Acute/Sub-Chronic Toxicity Test
The Biocompatibility Sub-acute and Sub-chronic Toxicity test is used to discover the effects a material with repeat exposure would have on a patient, including any compound toxicity effects. It determines the systemic effect of repeated doses of materials or their extracts for no less than 24 hours and no greater than 10% of the total life span of the test animal. This Biocompatibility Sub-acute/Sub-chronic Toxicity testing complies with ISO 10993-11.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]
- ISO 10993
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|SCX410||Sub-Acute Toxicity: 14 day and 14 dose (mice)||Add|
|SCX420||Sub-Acute Toxicity: 14 day and 14 dose (rats)||Add|
SCX410 - Sub-Acute Toxicity: 14 day and 14 dose (mice)
TAT: 91 days
SCX420 - Sub-Acute Toxicity: 14 day and 14 dose (rats)
TAT: 91 days
SCX410: 14 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX420: 14 complete devices, each device must be 270 cm2 or 9 grams. CSS Approval is needed to meet TAT.