Interpretation of the International Standard 2017 Version of Implantable Neurostimulators / 中国医疗器械杂志

ABSTRACT

ISO 14708-3 "Implants for surgery-active implantable medical devices-Part 3implantable 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.