医疗器械中DEHP替代增塑剂的应用与暴露研究概述  

Overview of the Application and Exposure to DEHP Alternative Plasticisers in Medical Devices

作　　者：李丹 田甜 补亚忠 LI Dan;TIAN Tian;BU Ya-zhong(Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA,Shanghai 201210;Institute of Medical Engineering,Department of Biophysics,School of Basic Medical Sciences,Health Science Center,Xi’an Jiaotong University,Shaanxi Xi’an 710061)

机构地区：[1]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海201210 [2]西安交通大学医学部基础医学院医学工程研究所,陕西西安710061

出　　处：《中国医疗器械信息》2024年第21期28-30,共3页China Medical Device Information

摘　　要：自邻苯二甲酸酯类增塑剂对人体产生的潜在副作用引发广泛关注,各国医疗器械监管机构开始倡导使用替代增塑剂。2024年6月,欧盟发布最新的医疗器械中邻苯二甲酸酯的受益/风险评估指南。文章汇总并梳理了指南中关于替代增塑剂的迁移特性、暴露途径和研究进展,期望对完善其安全性评价带来助益。Since the potential side effects of phthalate plasticisers on the human body have aroused widespread concern,medical device regulatory bodies in various countries have begun to advocate the use of alternatives.In June 2024,the European Union published updated guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.This paper summarizes the leaching and extractable properties,exposure pathways and research progress of alternative plasticisers in the guidelines,hoping to contribute to improving their safety evaluation.

关 键 词：医疗器械 邻苯二甲酸二(2-乙基己基)酯 替代增塑剂 安全评价 人体暴露 

分 类 号：R113[医药卫生—公共卫生与预防医学]