Acute Systemic Toxicity test. UNE-EN ISO 10993-11. Biological evaluation of medical devices.

Test Accredited by ENAC (National Accreditation Entity).

Test with the Certificate of Good Laboratory Practices (GLPs).

The release of chemical components from a medical device in the body can cause systemic toxicity. The acute systemic toxicity test is designed to provide evidence of the existence of systemic adverse effects. For the evaluation, extracts of the product obtained with polar solvents (physiological saline solution, hydroalcoholic solution 5%, water) or non-polar (vegetable oil) are used, with their corresponding controls of the solvents without having been exposed to the product.

To carry out the test, groups of 5 mice are used, which are inoculated intravenously or intraperitoneally, with a single dose of each of the extracts or their corresponding controls. The mice are observed daily for three days. The test is considered negative if none of the animals inoculated with the extract of the product shows a significant biological reaction greater than that observed in the animals inoculated as controls with the solvent used to prepare the extract of the device. If two or more of the inoculated mice die, or show signs of toxicity (clinical observation), or three or more of the mice lose more than 2 grams of weight, the product tested does not meet the requirements of the test. If the animals only show signs of a mild biological reaction, and no more than one animal shows significant signs of biological reaction or dies, the test should be repeated with groups of 10 mice. In these 10 mice, none must show signs of significant involvement, compared with the respective controls.