Standard: AAMI NS4

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

FEATURES & BENEFITS
  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

General

This standard establishes certain requirements for portable, battery-powered, transcutaneous electrical nerve stimulators (TENS devices) that are used in the treatment of pain syndromes, that are intended for use on intact skin and mucous membranes, and that do not require surgical intervention or violation of the skin surface.

Inclusions

Labeling requirements for the stimulus generator and for patient leads and electrodes are within the scope of the standard.

Minimum safety and performance requirements for the stimulus generator, including limits on output characteristics, are also within the scope of this standard.

Exclusions

This standard does not cover requirements for the electroconductive medium (gel) used to establish electrical contact between the patient electrodes and the skin, nor does it cover performance requirements for TENS leads/electrodes.

This standard does not cover requirements for line-powered TENS devices, diagnostic stimulators, stimulators for muscle exercise, electrostatic stimulators, electromagnetically coupled stimulators, or electrosleep devices.

NOTEā€“For an explanation of the need for this standard, and the rationale for its provisions, see Annex B.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ns4
Publish Date: 2013-01-01
Page Count: 23
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

This Standard References

Showing 2 of 2.


Advertisement
Advertisement
Advertisement
Advertisement