摘要
该文主要阐述ISO 14708-3《手术植入物-有源植入式医疗器械-第3部分:植入式神经刺激器》2017版相比于2008版的主要变化,结合神经刺激器产品的特点对标准的变化进行解读。新版标准首次提及新型无导线神经刺激器,并对无线充电温升、MRI可接受准则等对安全性影响重大的关键问题进行了相应规定,对无线通信部分增加了要求,对电磁兼容要求做了较大调整。随着更多的微型无导线产品进入市场,标准中如电磁兼容和MRI等部分,将会有更大调整。
ISO 14708-3"Implants for surgery-active implantable medical devices-Part 3:implantable neurostimulators"2017 version and 2008 version are compared,and changes in the standard are interpreted combined with the characteristics of the neurostimulator.The new version of the standard for the first time in the introduction mentioned a new type of non-electrode or extension’s neurostimulator.Key issues that have significant impact on safety concerns such as wireless charging temperature rise,MRI acceptance criteria,etc.,are given for the first time in the new version.New requirements to the wireless communication section are added,and the electromagnetic compatibility part is greatly adjusted.With more miniature non-electrode or extension’s neurostimulator entering the market,standards such as electromagnetic compatibility and MRI,there will be greater adjustments.
作者
王伟明
李路明
李青峰
胡春华
李冰
郝红伟
WANG Weiming;LI Luming;LI Qingfeng;HU Chunhua;LI Bing;HAO Hongwei(School of Aerospace,Tsinghua University,Beijing,100084)
出处
《中国医疗器械杂志》
2018年第2期133-136,共4页
Chinese Journal of Medical Instrumentation
基金
国家自然科学基金青年科学基金(61601258)
关键词
有源植入式神经刺激器
国际标准变化
标准研究
active implantable neurostimulator
international standard changes
standard research