ISO/TC 194/WG 7 - Systemic toxicity

ISO 10993-11:2017 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.

ISO/TS 10993-20:2006 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices. ISO/TS 10993-20:2006 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.

ISO 10993-11:2006 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.

Specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. Includes, in addition, pyrogenicity testing. The methods cited are from international standards, national standards, directives and regulations.