This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndrome. Also covered are labeling requirements for patient leads and electrodes. An appendix providing labeling/user guidelines for TENS devices is also included.
AAMI NS4:1986/(R)2009
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Transcutaneous Electrical Nerve Stimulators
Association for the Advancement of Medical Instrumentation , 08/10/2009
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