• AAMI IEC 60601-2-47 : 2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2021

    Language(s):  English

    Published date:  01-01-2016

    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
    Background of AAMI adoption of IEC 60601-2-47:2012
    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
           and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation
           HAZARDS
    201.11 Protection against excessive temperatures and other
           HAZARDS
    201.12 Accuracy of controls and instruments and protection
           against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and
           ME SYSTEMS
    202 Electromagnetic compatibility - Requirements and
           tests
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS.

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

    Development Note Supersedes AAMI EC38. (08/2012)
    Document Type Standard
    Product Note Reconfirmed 2012
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    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
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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