• ANSI/AAMI/IEC 60601-2-2:2017

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-06-2017

    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
    Background of ANSI/AAMI adoption of
     IEC 60601-2-2:2017
    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
            for ME EQUIPMENT
    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 DISTURBANCES - Requirements
            and tests
    202.2 Normative references
    202.3 Terms and definitions
    202.7 Electromagnetic emissions requirements for
            ME EQUIPMENT and ME SYSTEMS
    202.8 Electromagnetic IMMUNITY requirements for ME
            EQUIPMENT and ME SYSTEMS
    202.101 Index of defined terms
    208 General requirements, tests and guidance for
            alarm systems in medical electrical equipment
            and medical electrical systems
    Annexes
    Annex AA (informative) - Particular guidance and
             rationale
    Annex BB (informative) - ELECTROMAGNETIC DISTURBANCES
             created by HF SURGICAL EQUIPMENT
    Bibliography
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENTand HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

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

    Development Note Supersedes AAMI HF18. (01/2007)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    CENELEC GUIDE 29 : 2007 TEMPERATURES OF HOT SURFACES LIKELY TO BE TOUCHED GUIDANCE DOCUMENT FOR TECHNICAL COMMITTEES AND MANUFACTURERS
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    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 HF18 : 2001 ERRATA 2001 ELECTROSURGICAL DEVICES
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
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