Standards Development

Scope

This document specifies requirements that are generally applicable to active implantable medical devices.

NOTE 1 For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular parts of ISO 14708.

The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical devices 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 (for example by gas pressure or by springs).

This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the active implantable medical devices. Annex B provides a table showing the applicability of subclauses in this document to the different parts of an active implantable medical device (implantable, active non-implantable, and non-active non-implantable).

NOTE 2 The device that is commonly referred to as an active implantable medical devices can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 3 In this document, italicized terms are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not italicized unless the concept thus qualified is also defined.