Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators

This standard outlines the requirements for active implantable medical devices, specifically focusing on implantable neurostimulators. It provides detailed specifications regarding design, performance, and safety aspects to ensure the devices meet necessary quality criteria. The document includes guidelines for testing and evaluation procedures to confirm compliance with established benchmarks. It also addresses the necessary documentation and labeling requirements for such medical devices. The standard covers essential aspects related to material selection, electrical safety, and biocompatibility. Additionally, it specifies the conditions under which these devices should be used and maintained. The content is structured to facilitate the development, testing, and certification of implantable neurostimulators in accordance with international standards.