Full Description

Specifies requirements for marking, labelling, packaging and accompanying documentation for implantable neural stimulators intended for stimulation of the nervous system (brain, spinal cord, peripheral nerves and adjacent structures). Also covers implanted or external ancillary components, including the external control and programming equipment used for the activation or adjustment of neural stimulators. Does not specify indications or contraindications for the use of implantable neural stimulators, nor testing or the range of normal operating variable parameters.