The biocompatibility systemic toxicity tests are in vivo systemic tests used to evaluate the impairment or activation of a system, rather than the impairment of individual cells or organs. Acute systemic toxicity tests and pyrogenicity tests are included in the systemic toxicity tests.

Acute Systemic Toxicity Testing

Acute toxicity is considered to be the adverse effects that occur after administration of a single dose or repeated doses of a test article given within 24 hours. Acute systemic toxicity test determines the systemic toxic effect followed by a single acute exposure of medical biomaterials to the body. The acute systemic test can provide extensive instruction on health hazards which may be induced by acute exposure from a medical device or chemical material. The animals are administrated with test material extracts or the liquid chemical; subsequently, observed at 24 ± 2, 48 ± 2, and 72 ± 2 hours for signs of toxicity.

Pyrogenicity Testing

Pyrogens are some chemical or bacterial-sources compounds which can cause a fever when present in the body at sufficiently high doses. Pyrogenicity test is used to detect the material-mediated fever-causing reactions caused by extracts of medical devices or chemical materials. The material-mediated pyrogen evaluates the potential of a chemical substance in/on a medical device to cause a pyrogenic response. Remarkably, no single test can differentiate pyrogenic reactions material-mediated from those caused by endotoxin contamination. The animals are dosed with the test article extract and observed for 3 hours.

Standard for Acute Systemic Toxicity and Pyrogenicity

"Tests for systemic toxicity", part eleven of the Biological evaluation of medical devices standards(ISO 10993-11), gives out the general considerations that should be taken into account when evaluating the potential of inducing acute systemic toxicity and pyrogenicity of a medical device. According to the study procedures mentioned in ISO 10993-11 for the assessing of the potential of medical devices and their constituent materials to induce systemic toxicity, STEMart offers the following systemic toxicity testing service:

Test Capabilities

For Acute Systemic Toxicity Test

· Test Methods

1) Acute oral toxicity test;

2) Acute dermal toxicity test;

3) Acute inhalation toxicity test;

4) Acute intravenous toxicity test;

5) Acute intraperitoneal toxicity test.

· Test Animals

Mice, rats, or rabbits

· Test Items

1) Visual observations of animals;

2) Routine hematology and serum chemistry tests with blood samples;

3) Microscopic examination with representative tissue samples.

For Pyrogenicity Test

· Test Method

Limulus amebocyte lysate (LAL) reagent test

STEMart offers Acute System Toxicity and Pyrogenicity testing following the biocompatibility guidelines modified for medical devices. If you have additional questions about systemic toxicity tests or would like to find out more about our services, please feel free to contact us.

Reference

Wallin, Richard F., et al. "A Practical Guide to IS0 10993-11: Systemic Effects." MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY 20: 98-101 (1998).