Systemic Injection (Acute Systemic Toxicity) Test

Systemic toxicity testing or acute systemic injection testing is a test method that provides general information on health hazards from acute exposure to a medical device or chemical. Animals are dosed with test sample extracts or liquid chemical by injection and then observed at 24 plus/minus 2, 48 plus/minus 2 and 72 plus/minus 2 hours for various signs of toxicity.

Material-mediated pyrogen assesses the ability of a chemical agent or other substance in or on a medical device to produce a pyrogenic response. Animals are given sample extract by injection and observed for 3 hours. During this observation period, a temperature change of less than plus 0.5 degrees Celsius is sought in each animal.

These tests are performed on any device that will touch the inside of the patient's body and comply with the following standards developed by the International Standards Organization (ISO):

• ISO 10993-11 Biological evaluation of medical devices - Part 11: Systemic toxicity tests. This standard describes requirements for procedures to be followed in assessing the potential of medical device materials to cause adverse systemic reactions.
• ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. This standard primarily describes the requirements for the selection of reference materials and procedures for the preparation of samples for medical device testing in biological test systems in accordance with one or more parts of the ISO 10993 series. This standard specifically addresses: test sample selection, selection of representative sections from a medical device, test sample preparation, experimental controls, selection and requirements of reference materials, and preparation of extracts.

Systemic toxicity refers to toxicity that is not limited to adverse effects at the point of contact between the body and the device. Systemic toxicity requires absorption and distribution of a toxic substance from the point of entry to a distant site where harmful effects are produced. Acute systemic toxicity refers to adverse effects occurring any time within 24 hours after a single, multiple or continuous exposure of a test sample over 72 hours.

Our organization also provides systemic injection (acute systemic toxicity) testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.