植入式神经刺激器国际标准2017版解读

Interpretation of the International Standard 2017 Version of Implantable Neurostimulators

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.