YY 1493-2016 in English

This standard specifies the technical requirements, test methods, and marking for gravity-controlled peritoneal dialysis equipment. It covers aspects such as structural design, material selection, safety performance, and functional requirements. The standard also outlines the requirements for infection control, user interface, and operational instructions. Additionally, it includes requirements for electromagnetic compatibility, electrical safety, and mechanical stability. The document provides detailed information on performance verification, quality control, and packaging requirements. It is applicable to the design, manufacture, and testing of gravity-controlled peritoneal dialysis equipment intended for medical use. The standard aims to ensure the safety, effectiveness, and reliability of the equipment throughout its intended use and lifecycle.