YY 0645-2018 Continuous blood purification equipment

Scope

This standard specifies the terms and definitions, classification and marking, requirements, test methods, labels, user manuals, and packaging, transportation, and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as the equipment). The equipment does not have the function of preparing replacement fluid or dialysis fluid, and can be used for continuous blood filtration and other blood purification treatments for more than 24 hours. This standard does not apply to: -- water treatment devices; -- peritoneal dialysis equipment; -- equipment with only blood perfusion mode; -- equipment with only plasma therapy mode; -- hemodialysis equipment; -- other equipment with the function of preparing replacement fluid or dialysis fluid.

Development Information

Replace the following standards

Referenced Standards

Related Standards