Standard: AAMI - 14708-3

IMPLANTS FOR SURGERY—ACTIVE IMPLANTABLE MEDICAL DEVICES—PART 3: IMPLANTABLE NEUROSTIMULATORS

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Scope:

This part of ISO 14708 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.

This part of ISO 14708 is also applicable to all 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 neurostimulation devices. However, it does apply to devices intended to be used as trial screeners because of their close affiliation with implantable neurostimulators.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: 14708-3
Publish Date: 2008-01-01
Page Count: 59
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
14708-3 Change Type: Update Date: 2008-01-01 Status: INAC

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