This standard specifies the requirements for identification, labeling, packaging and accompanying documentation of implantable neurostimulators used to stimulate the nervous system (brain, spinal cord, peripheral nerves and adjacent tissues). This standard also covers implantable or externally accessible ancillary components, including external controllers and programmers for activation or adjustment of neurostimulators. This standard does not specify indications or contraindications for the use of implantable neurostimulators; nor does it specify ranges of variable parameters for testing or routine operation. However, this standard requires that this relevant information be included in the documentation accompanying each implanted pulse generator, implanted RF receiver, or RF transmitter used by clinicians to treat patients.
YY/T 0684-2008 history
2008YY/T 0684-2008 Neurosurgical implants.Marking and packaging of implantable neural stimulators