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Systemic Toxicity Test

Systemic Toxicity Test

The Biocompatibility Acute Systemic Toxicity test evaluates the potential adverse effects of a medical device on the body’s organs and tissues that are remote from the site of contact. Depending on the type of device being tested, the following applications may be observed for toxicity: topical, inhalation, intravenous, intra peritoneal or oral administration of extracts, or implantation of the device in the animal. This test is performed on any device that would contact the interior of a patient’s body and complies with ISO 10993-11.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ISO 10993

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SCX305 Systemic Toxicity: Systemic Injection (USP), 2 extracts 35 Add
SCX310 Systemic Toxicity: Systemic Injection (ISO), 2 extracts 40 Add
SCX315 Systemic Toxicity: Systemic Injection (ISO), liquid/chemical 35 Add
SCX320 Systemic Toxicity: Material Mediated Pyrogen, each 40 Add
SCX305 - Systemic Toxicity: Systemic Injection (USP), 2 extracts
TAT: 35 days
SCX310 - Systemic Toxicity: Systemic Injection (ISO), 2 extracts
TAT: 40 days
SCX315 - Systemic Toxicity: Systemic Injection (ISO), liquid/chemical
TAT: 35 days
SCX320 - Systemic Toxicity: Material Mediated Pyrogen, each
TAT: 40 days

Sample Specifications

SCX305: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX310: 2 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX315: 10 mL. CSS Approval is needed to meet TAT.
SCX320: 900 cm2 or 30 grams. CSS Approval is needed to meet TAT.

Study Outline

In the Biocompatibility Systemic Toxicity test, mice are injected intraperitoneally or intravenously with either extracts or solutions of the test article or control (vehicle without test article). The animals will be observed for signs of toxicity immediately after injection and at 4 ± 0.75, 24 ± 2, 48 ± 2 and 72 ± 2 hours post-injection. Body weights will be measured prior to injection and on all three subsequent days.
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