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  • EN 60601-2-20:2009/A1:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)

    Available format(s): 

    Superseded date:  01-02-2022

    Language(s): 

    Published date:  12-01-2013

    Publisher:  European Committee for Standards - Electrical

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

    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 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
    212 Requirements for medical electrical equipment
        and medical electrical systems intended for use in
        the emergency medical services environment
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EC Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment.

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

    Committee TC 62
    Development Note SUPERSEDES HD 395.2.20 To be read in conjunction with EN 60601-1:1990 (05/2001)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

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

    BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
    DIN EN 60601-2-35 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
    UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
    UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    DIN EN 13976-1 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 80601-2-35 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
    16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
    DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

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

    IEC 60601-2-21:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    IEC 60601-2-19:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    IEC 60601-2-50:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    EN 60601-2-50:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009/A1:2016)
    EN 60601-2-19:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016)
    EN 60601-1-10:2008/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007)
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    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
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN ISO 21647:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
    EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
    EN 60601-2-21:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
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