规定了通常适用于主动植入式医疗设备的要求。本文件中规定的试验为型式试验，将在有源植入式医疗设备的样品上进行，以证明符合性。本文件不仅适用于电动的有源植入式医疗设备，也适用于由其他能源驱动的设备。本文件也适用于有源植入式医疗设备的一些非植入式零件和附件。

Specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in this document are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This document is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources. This document is also applicable to some non-implantable parts and accessories of the active implantable medical devices.