scope:

This part of ISO 14708 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.

This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices as defined in Clause 3.

The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

NOTE This part of ISO 14708 is not intended to apply to non-implantable infusion systems. However, it does apply to devices intended to be used as trial systems because of their close affiliation with implantable infusion pumps.