This part of ISO 10993 specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. In addition, it includes pyrogenicity testing.

The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachebles be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.