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.
ISO 10993-11:1993 history
2017ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
2006ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
1993ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity