关于聚氯乙烯材质医疗器械细胞毒性可能风险点及检测方法的几点思考  

Some Thoughts on Possible Risk Points and Detection Methods of Cytotoxicity of PVC Material Medical Devices

作　　者：伍锡栋 林引花 WU Xi-dong;LIN Yin-hua(Department of the Fourth Inspection,Jiangxi Testing Center of Medical Instrumenta,Jiangxi Nanchang 330000;School of Pharmacy,Nanchang University,Jiangxi Nanchang 330000)

机构地区：[1]江西省医疗器械检测中心,江西南昌330000 [2]南昌大学药学院,江西南昌330000

出　　处：《中国医疗器械信息》2022年第21期24-26,66,共4页China Medical Device Information

基　　金：江西省市场监督管理局(项目编号:GSJK201913)。

摘　　要：聚氯乙烯(Polyvinyl Chloride,PVC)因为性能稳定、价格低廉而广泛应用于医疗器械领域。PVC需要根据使用的需求不同而加入不同比例的增塑剂、热稳定剂、色素等添加剂,但是因为添加剂的使用会造成一定的生物毒性,对人体健康造成危害。在PVC材料加工时增塑剂和热稳定剂的使用量最大。文章主要分析PVC材质中增塑剂、热稳定剂的生物毒性,概述PVC材质医疗器械的生物安全性评价及检测方法,医疗器械的材质、状态、组成及添加物质均决定了生物毒性检测方法的选择,在实际检测过程中细胞毒性的检测应尽可能综合2种以上方法的结果进行评价。PVC is widely used in the field of medical devices because of its stable performance and low price.PVC needs to add different proportions of plasticizer,heat stabilizers,pigments and other additives according to different needs,but the use of additives will cause certain biological toxicity and cause harm human health.The use of plasticizer and thermal stabilizers in the processing of PVC materials are the two additives.This paper mainly analyzes the influence of plasticizer and heat stabilizer on biotoxicity in PVC material,and describes the biosafety evaluation and detection methods of PVC material medical devices.The material,state,composition and added substances of medical devices all determine the selection of biological toxicity detection methods.In the actual detection process,the detection of cytotoxicity should be evaluated by integrating the results of more than two methods as far as possible.

关 键 词：聚氯乙烯(PVC) 增塑剂 热稳定剂 琼脂扩散法 MTT法 

分 类 号：TB324[一般工业技术—材料科学与工程]