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  • AAMI TIR69 : 2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-01-2021

    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
    Introduction
    1 General
    2 Reference standards and documents
    3 Definitions
    4 Risk management
    5 Overview of process
    6 Pre-test preparation
    7 Wireless coexistence test methodology
    8 Post-test analysis
    9 Summary report and documentation
    Annex A: Glossary of additional terms
    Annex B: Report template
    Annex C: Example of wireless test report
             for a minor risk device
    Annex D: Example of wireless test report
             for a major risk device
    Annex E: Wireless functions and risk
             Categories
    Annex F: Intended use environments
    Annex G: Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to medical devices and systems (also known as medical electrical equipment) that incorporate RF wireless technology used to perform or control a medical function or to communicate medical data.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

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

    ANSI/AAMI/IEC 80001-1:2010 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
    IEEE 1900.1-2008 IEEE Standard Definitions and Concepts for Dynamic Spectrum Access: Terminology Relating to Emerging Wireless Networks, System Functionality, and Spectrum Management
    IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
    ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
    AAMI/IEC TIR80002-1:2009 MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
    ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
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