Glossary Term
Toxicology Testing
Definition
Toxicology testing is the process of assessing the potential harmful effects of substances, materials, or products on human health. In the context of the MedTech industry, it refers to the evaluation of medical devices, materials, or components to determine whether they pose any toxicological risks to patients or healthcare providers. This type of testing evaluates factors such as cytotoxicity, genotoxicity, carcinogenicity, and irritation potential, ensuring that medical devices are safe for use in clinical environments. Toxicology testing is essential for regulatory approvals, ensuring that products meet safety standards before they are marketed to the public.
Relevance to the MedTech Industry
Toxicology testing is a critical component of the product development process. It ensures that medical devices, biomaterials, and drug delivery systems do not cause harm to patients when used as intended. Regulatory bodies like the FDA, EMA, and ISO standards require comprehensive toxicological assessments before approving devices for use. Medical device manufacturers must prove that their products are biocompatible and do not release harmful substances that could affect patients. Toxicology testing can also help identify potential risks associated with new materials or devices, enabling the development of safer products.
Additional Information & Related Terms
Related Terms
Biocompatibility: The ability of a material or device to interact safely with biological systems, including its impact on cells, tissues, and organs.
Regulatory Testing: A series of tests required by regulatory agencies like the FDA or EMA to confirm that a medical device meets safety and performance standards.
In Vitro Testing: Laboratory tests conducted on cells or tissues outside of a living organism, often used in toxicology testing to assess the cytotoxicity or genotoxicity of materials.
Preclinical Testing: Studies conducted on animal models before clinical trials to evaluate the safety and efficacy of a medical device or drug, including toxicology testing.
ISO 10993: An international standard for evaluating the biocompatibility of medical devices, which includes guidelines for toxicological testing of materials used in devices.