IS 14679 : 1999 Neurosurgical implants - Implantable perpheral nerve stimulators

1 Scope

This standard establishes safety and performance requirementsfor implantable peripheral nerve stimulators intended for use inthe relief of chronic, severe pain. The standard covers allelements of the peripheral nerve stimulation system, which consistsof an implanted receiver, connected electrodes placed on or aroundthe nerve, and an external transmitter for transmitting stimulatingpulses across the patient's skin to the implanted receiver.

Transcutaneous electric nerve stimulators, spinal cordstimulators, totally implantable nerve stimulation system (that is,those with implantable pulse generators), and nerve stimulatorsintended for other applications, such as phrenic nerve diaphragmpacing are however not covered in this standard.

2 Reference

IS 13450 : Part 1 :1994 Medical electrical equipment: Part 1Generalrequirements for safety