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  • AAMI NS4 :2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2021

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Foreword
    1 Scope
    2 Normative references
    3 Requirements
    4 Test Methods
    5 Glossary
    Annexes
    Annex A (informative) - Labeling/User
            Guidelines for Transcutaneous
            Electrical Nerve Stimulators
            (Contraindications, Warnings,
            Precautions)
    Annex B (informative) - Development and
            Provisions of this Standard
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies 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.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Product Note Reconfirmed 2013
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
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