ISO 10993-4:2017

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ISO 10993-4:2017 is a standard that outlines the general requirements for evaluating the interaction between medical devices and blood. It focuses on the biological evaluation of medical devices, specifically in situations where they come into contact with blood. The standard provides guidelines for classifying medical devices based on their intended use and duration of contact with blood. It also outlines the fundamental principles for evaluating these interactions and provides a rationale for selecting specific tests for different device categories.