How To Evaluate The Safety Of DEHP In Single Use Hemodialysis Tubing Made Of PVC Raw Materials Plasticized By DEHP?

When evaluate the safety of DEHP, suitable extraction solution (e.g. ethanol water) and test method should be adopted to detect the total amount of DEHP extractable in the product by using the tubing set with the highest DEHP content and simulating the most stringent clinical usage conditions (e.g. reference to the method of preparing test solution for chemical performance as specified in YY 0267, a flow rate of 200 mL/min or the maximum blood flow rate declared for the product in clinical use, circulation at 37°C for 5.5 hours). At the same time, the toxicity analysis, safety limit of human blood exposure to DEHP and the corresponding source basis should be provided, and intended population with different body weights should be evaluated respectively concerning their physiological characteristics for the safety of DEHP