AS ISO 14708.1-2003

AS ISO 14708.1-2003 Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
standard by Standards Australia, 01/01/2003

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Full Description

Specifies requirements that are generally applicable to active implantable medical devices. For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying ISO 14708-1 to active implantable medical devices where no particular standard exists. The tests that are specified in ISO 14708-1 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. Applicable to active implantable medical devices that are electrically powered, devices powered by other energy sources (for example gas pressure or springs) and to some non-implantable parts and accessories of the devices.