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The emphasis for standardization of implantable stimulating electrodes should be on performance. Among the functional characteristics of the stimulating electrode, only the physical properties may be amenable to some immediate performance standardization. Electrical properties of the stimulating electrode relating to safety may be defined in terms of performance standards in the near future, while those relating to efficacy may evolve later. Standardization of impedance or other electrical design characteristics should not be considered apart from their direct, verified relationship to safety and efficacy of the implant.
DirectorMember of ASTM, Neurological Research, Medtronic, Inc., Minneapolis, Minn.
Stock #: JTE11636J