Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.

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

This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs).

This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).

Other parts of this product are listed below:

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)