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  • BS EN 80601-2-35 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-12-2021

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  British Standards Institution

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

    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
    208 General requirements, tests and guidance for ALARM SYSTEMS
        in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
        SYSTEMS
    210 Requirements for the development of physiologic closed-loop
        controllers
    Annex D (informative) - Symbols on marking
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (normative) - Determination of the LAGGING MATERIAL
    Annex CC (normative) - Determination of heat transfer towards
             the PATIENT
    Annex DD (normative) - Determination of heat transfer away from
             the PATIENT
    Annex EE (normative) - Conditions of adequate heat discharge
    Annex FF (normative) - Test procedure for maximum CONTACT SURFACE
             TEMPERATURE for FORCED AIR DEVICES
    Annex GG (normative) - Test procedure for maximum CONTACT SURFACE
             TEMPERATURE for FORCED AIR DEVICES under SINGLE FAULT
             CONDITION
    Annex HH (normative) - Safety test procedure for average CONTACT
             SURFACE TEMPERATURE for FORCED AIR DEVICES
    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 HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use.

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

    Committee CH/62/4
    Development Note Supersedes BS EN 60601-2-35 & BS 5724-2.35(1997). (03/2010) Supersedes 07/30151731 DC. 2009 Edition remains current. (03/2012) Supersedes 15/30323081 DC. 2009 Edition Re-issued in January 2017 & incorporates AMD 1 2016. 2009 + A11 2011 Edition remains current and will be withdrawn on 16/12/2019.(02/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 60601-2-20:2009/A1:2016 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)
    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 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    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)
    IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
    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)
    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 60601-1-2:2014 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 60335-2-53:2011 Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances and infrared cabins
    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)
    IEC 60335-2-53:2011+AMD1:2017 CSV Household and similar electrical appliances - Safety - Part 2-53: Particular requirements for sauna heating appliances and infrared cabins
    ISO 2439:2008 Flexible cellular polymeric materials Determination of hardness (indentation technique)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 2439:2008 Flexible cellular polymeric materials - Determination of hardness (indentation technique) (ISO 2439:2008)
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
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