GB 16174.1-2024

This document specifies the general requirements for active implantable medical devices.
This document applies to electrically powered active implantable medical devices, active implantable medical devices powered by other energy sources (e.g., gas pressure or springs), and certain non-implantable parts and accessories of active implantable medical devices.
Note 1: For specific active implantable medical devices, these general requirements are supplemented or modified by the requirements of dedicated parts.
The tests specified in this document are type tests, which are used to demonstrate the conformity of active implantable medical devices by testing samples of these devices.
Note 2: Devices commonly referred to as active implantable medical devices may be individual devices, combinations of multiple devices, or a combination of a device or multiple devices with one or more accessories. Not all of these components need to be fully or partially implanted, but if the non-implantable parts and accessories affect the safety or performance of the implantable device, certain requirements must be imposed on these components and accessories.