Safety and Performance Evaluation Method for Wearable Artificial Kidney Systems

Abstract

This paper focuses on international standards and guidelines related to evaluating the safety and performance of wearable dialysis systems and devices. The applicable standard and evaluation indices for safety and performance are determined, and the relevant international standards and guidelines are provided in a table. In addition, example experiments using a triaxial accelerometer and robot arm are presented for testing the endurance and safety of wearable artificial kidneys. The findings in this paper can be used to suggest new guidelines for the mechanical safety and performance evaluation of wearable artificial kidney systems.