AAMI NS14:1995

This standard establishes minimum labeling, safety and performance requirements for internally and/or externally powered implantable spinal cord stimulators. The standard covers all electrode configurations and all elements of the spinal cord stimulation system. The system consists of an implanted pulse generator, connected electrodes placed over the spinal cord, and an external transmitter or programmer for transmitting energy and/or information across the patient's skin to the implanted pulse generator. This standard covers electrodes implanted by a surgical procedure (a laminectomy) or introduced percutaneously. The devices (electrodes, pulse generator, and transmitter) used in the trial period of spinal cord stimulation are also included within the scope of this standard. Also covered by this standard are spinal cord stimulators that produce current affecting other areas of the spinal cord, including those stimulators that pass current through the spinal cord in an anterior-posterior direction.