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.
SANS 10993-11:2003 history
2008SANS 10993-11:2008 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
2003SANS 10993-11:2003 Biological evaluation of medical devices Part 11: Tests for systemic toxicity