Considerations for Regulatory Evaluation of Surface Coating on Cardiopulmonary Bypass Consumables
CAI Nana
GUO Yajuan
WANG Yunbing
HE Xiaofan
YANG Yuxi
JIAO Guohui
LUO Qingfeng
Abstract：Surface coating on cadiopulmonary bypass(CPB)consumables significantly reduces reactions such as throm-bosis,inflammation and hemolysis by improving the interaction between material and blood.However,they also raise concerns about long-term safety and associated risks.This article primarily elaborates on key aspects for the preclinical evaluation of surface coatings on CPB consumables,focusing on product description,raw material control,toxicology research,performance evaluation and production process,Corresponding evaluation methodologies for relevant properties are discussed.The aim is to enhance the scientific comprehensiveness of both the development and evaluation of these coatings,thereby reducing the clinical risks posed by coatings in related products.
Keywords：cadiopulmonary bypasssurface coatingconsumablesevaluation
Publication Date：2025-12-28
Online Publishing Date：2026-01-16(First online date of this platform, not the publication date of the document)
Pages：3( 549-551 )