Provides general requirements for evaluating the interactions of medical devices with blood. It describes a classification of medical and dental devices that are intended for use in contact with blood, the fundamental principles governing the evaluation of the interaction of devices with blood, the rationale for structured selection of tests according to specific categories and the principles and scientific basis of these tests. It describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
SANS 10993-4:2004 history
2004SANS 10993-4:2004 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood