ISO 10993-4 specifies general requirements for evaluating the interactions of medical devices with blood. The selection and design of test methods for the interactions of medical devices with blood should consider device design, materials, clinical utility, usage environment and risk-benefit. This level of specificity can only be covered in standards. The initial source for developing ISO 10993-4 was the publication, Guidelines for blood/material interactions, Report of the National Heart, Lung, and Blood Institute.
ISO 10993-4 describes:
a) classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for the structured selection of tests according to specific categories and the principles and scientific basis of these tests.
The text of ISO 10993-4:2017 has been approved in Europe as EN ISO 10993-4:2017 without any changes.
