• EN 60601-2-35:1996

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

    Available format(s): 

    Superseded date:  01-12-2009

    Language(s): 

    Published date:  13-12-1996

    Publisher:  European Committee for Standards - Electrical

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

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

    INTRODUCTION
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    5 Classification
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
    HAZARDS
    17 Separation
    19 Continuous leakage currents and patient auxiliary
        currents
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
    OR EXCESSIVE RADIATION
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
    FLAMMABLE ANAESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
    AND OTHER SAFETY HAZARDS
    42 Excessive temperatures
    44 Overflow, spillage, leakage, humidity, ingress of
        liquids, cleaning, sterilization, disinfection and
        compatibility
    46 Human errors
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
    AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
    51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
    ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    54 General
    56 Components and general assembly
    57 Mains parts, components and layout
    59 Construction and layout
    Figures
    101aPositioning of temperature sensors on the contact
        surface of the heated area of a heating device
    101bExample of the positioning of temperature sensors
        on the contact surface of the heated areas of a
        heating device having more than one separately heated
        area
    102 Ramp for the impact test on pads
    103 Partial covering conditions
    104 Method of folding blankets
    105 Examples of folds
    106 Positions of a blanket for the ruck-resistance test
    107aApparatus for the spark ignition test
    107bDetails of an apparatus for the spark ignition test
    108 Illustration of the main requirements of this
        Standard
    Appendix/Annexes
    L References - publications mentioned in this standard
    AA (informative) Rationale to particular subclause
    BB (normative) Determination of the lagging material
    CC (normative) Procedure for determining whether a
        heating device provides high or low heat transfer
        from the heat source to the contact surface (i.e.
        towards the patient
    DD (normative) Procedure for determining whether a heating
        device provides high or low heat transfer from the
        contact surface to the heat source (i.e. away from
        the patient)
    EE (normative) Normative references to international
        publications with their corresponding European
        publications
    ZB (informative) Normative references to international
        publications with their corresponding European
        publications

    Abstract - (Show below) - (Hide below)

    Establishes requirements, which minimize hazards to patient and operator, for heating devices such as blankets, pads, mattresses and fluid-filled mattresses. Specifies tests by which compliance can be verified.

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

    Committee CLC/TC 62
    Development Note 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

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

    PREN 12182 : 2009-06 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
    09/30201992 DC : 0 BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS

    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 60384-14:2013+AMD1:2016 CSV Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
    ISO 3743-2:1994 Acoustics Determination of sound power levels of noise sources using sound pressure Engineering methods for small, movable sources in reverberant fields Part 2: Methods for special reverberation test rooms
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    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
    ISO 2439:2008 Flexible cellular polymeric materials Determination of hardness (indentation technique)
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective