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.
SANS 10993-11:2008 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