YY 1274-2016 in English

This standard specifies the technical requirements, test methods, and marking for pressure-controlled peritoneal dialysis devices. It covers aspects such as design, performance, safety, and reliability to ensure the device functions properly under various operating conditions. The standard outlines the requirements for materials used in the device, as well as the procedures for verification and validation. It also includes guidelines for labeling, user instructions, and packaging to facilitate proper use and handling. The scope of the standard includes both the device itself and its associated components, ensuring that all parts meet the necessary quality and safety criteria. The standard provides detailed information on the performance evaluation of the device, including pressure control accuracy, flow rate stability, and alarm systems. It is applicable to manufacturers, testing institutions, and regulatory bodies involved in the production and evaluation of such medical devices.