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  • NEMA/MITA 1:2015

    Current The latest, up-to-date edition.

    Good Refurbishment Practices for Medical Imaging Equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  22-02-2016

    Publisher:  National Electrical Manufacturers Association

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

    Foreword
    Introduction
    Section 1 - GENERAL
    Section 2 - SCOPE
    Section 3 - NORMATIVE REFERENCES
    Section 4 - TERMS AND DEFINITIONS
    Section 5 - GENERAL REQUIREMENTS FOR
                REFURBISHMENT OF USED MEDICAL DEVICES
    Section 6 - SPECIFIC REQUIREMENTS FOR GOOD
                REFURBISHMENT PRACTICE

    Abstract - (Show below) - (Hide below)

    Lays out the basic requirements for a refurbishment process for medical electrical equipment which will not change the equipment’s original intended use, safety profile, or performance.

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

    Document Type Standard
    Publisher National Electrical Manufacturers Association
    Status Current

    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
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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