摘要
乳房植入体作为植入性高风险医疗器械,直接关系到患者的身心健康和生活质量。这类产品属于长期植入器械,且涉及面广,其有效性和安全性一直受到社会的密切关注。硅凝胶填充的乳房植入物是近年来国际上最常用、最流行的整形假体,其壳体和填充凝胶的主要原材料均为聚二甲基硅氧烷材料。文章对医院取出的硅凝胶填充乳房植入体的部分化学性能进行测试,与现行标准进行对比,并提出相关建议。
As an implantable high-risk medical device,mammary implant is directly related to the physical and mental health and quality of life of patients.Such products are long-term implantable devices and involve a wide range of areas.Their effectiveness and safety have always been closely watched by the society.silicone gel Filled mammary implant is the most commonly used and popular plastic prosthesis in the world in recent years.The main raw materials of its shell and filling silicone gel are polydimethylsiloxane materials.In this paper,partial chemical properties of silicone gel-filled mammary implant replaced by hospitals are tested,compares them with current standards,and puts forward relevant recommendations.
作者
谢胜芬
刘珍珍
王云英
XIE Sheng-fen;LIU Zhen-zhen;WANG Yun-ying(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2022年第9期22-25,共4页
China Medical Device Information
关键词
取出的硅凝胶填充乳房植入体
测试
化学性能
建议
retrieved silicone gel Filled mammary implant
test
the chemical properties
suggestions