4707 Highway 61 N, Suite 250, White Bear Lake, MN 55110
A science that deals with poisons and their effect and with the problems involved (such as clinical, industrial, or legal problems).(1)
Toxicology is an important field of study, as it ensures the safety of product consumers. According to Green Chemistry: An Inclusive Approach, toxicology is important to, “design safer chemicals, for planning safer chemical synthesis, and to ensure that industrial processes employ safer, healthier, and sustainable chemistries”.(2) Technological advances in medical devices must come with assurance that products do not adversely affect the individuals using them.
Toxicology has historically been synonymous with the study of poison and development of antidotes but has evolved to encompass several disciplines. Toxicologists are now involved in the study of environmental and occupational toxic substances among other applications. In the medical industry, toxicology has evolved to encompass public health risks in foods, cosmetics, and drugs.(3) A common, global standard for toxicology and its relation to medical devices is ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity. Part 18 MicroBio Consulting stays informed with ISO 10993-11 along with other relevant ISO standards, as new updates arise.
Toxicological testing occurs during the developmental stage of a product, or there is a design change. Toxicologists analyze and test medical devices, along with other products in the medical device industry around the world. With the establishment of ISO 10993-11, testing required around the world is more consistent.
Validation of medical devices, drugs, and cosmetic products requires toxicological risk assessments conducted by various test labs. For medical devices, possible testing required includes acute systemic toxicity and repeated exposure systemic toxicity, but testing differs by contact type of the device.(4) Our team works directly with ISO 10993-accredited test labs to ensure our clients meet the requirements laid out in that standard, again ensuring consumer safety for medical devices.