Does It Need To Add Warning Information Related To DEHP To The Instructions For Use Of Infusion Set Products Made Of DEHP-plasticized Polyvinyl Chloride (PVC)?


Yes. It is required. The product IFU of the infusion set with DEHP-plasticized polyvinyl chloride (PVC) as the raw material for tubing should include the following:

  1. Clearly identify that the product contains DEHP;
  2. The warning information should clarify the following related information:① DEHP-related toxicity;②”This product is not suitable for storage and infusion of fat-soluble liquids and drugs such as fat emulsion”; (3) “Newborn, pre-pubertal men, pregnant and lactating women should not use this product for infusion of drugs.