ISO 10993-11 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. Systemic toxicity is a potential adverse effect of the use of medical devices. Generalized effects, as well as organ and organ system effects, can result from the absorption, distribution, and metabolism of leachates from the device or its materials to parts of the body with which they are not in direct contact.
Because of the broad range of medical devices, and their materials and intended uses, ISO 10993-11 is not overly prescriptive. While it addresses specific methodological aspects to be considered in the design of systemic toxicity tests, proper study design must be uniquely tailored to the nature of the device’s materials and its intended clinical application. Toxicology is an imperfect science. The outcome of any single test should not be the sole basis for deciding of whether a device is safe for its intended use. The text of ISO 10993-11:2017 has been approved in Europe as EN ISO 10993-11:2018 without any changes.