What Aspects Should Be Paid Attention To In Biocompatibility Evaluation Of Single Use Tubing Systems For Hemodialysis?

The biocompatibility evaluation study of such products should pay attention to the following: the administrative counterpart should provide a biological evaluation report that meets the requirements of GB/T 16886.1 according to the intended clinical use of the products. If biological test are conducted for such products, the relevant evaluation test should be carried out in accordance with the requirement that the product is in direct contact with circulating blood and the cumulative contact duration exceeds 30 days.