Biological evaluation of medical devices — Part 11: Tests for 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.
Control charts — Part 5: Specialized control charts
ISO 7870-5:2014 establishes a guide to the use and understanding of specialized control charts in situations where commonly used Shewhart control chart approach to the methods of statistical control of a process may either be not applicable or less efficient in detecting unnatural patterns of variation of the process.
