• IEC 60601-2-35:1996

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  26-09-2020

    Language(s):  English - French, Spanish, Castilian

    Published date:  06-11-1996

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    Clause
    SECTION ONE - GENERAL
    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
    Appendix/Annexes
    L References - Publications mentioned in this standard
    AA Rationale to particular subclauses
    BB Determination of the lagging material
    CC 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 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 CONDITIONS OF ADEQUATE HEAT DISCHARGE

    Abstract - (Show below) - (Hide below)

    Establishes requirements, which minimize hazards to patient andoperator, for heating devices such as blankets, pads, mattresses andfluid-filled mattresses. Specifies tests by which comliance canbe verified.

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

    Committee TC 62/SC 62D
    Development Note Also numbered as BS EN 60601-2.35 & BS 5724-2.35(1997). (11/2005)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Withdrawn
    Superseded By

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

    BS ISO 17966:2016 Assistive products for personal hygiene that support users. Requirements and test methods
    I.S. EN 61219:1994 LIVE WORKING - EARTHING OR EARTHING AND SHORT-CIRCUITING EQUIPMENT USING LANCES AS A SHORT-CIRCUITING DEVICE - LANCE EARTHING
    EN 61219:1993 Live working - Earthing or earthing and short-circuiting equipment using lances as short-circuiting device - Lance earthing
    13/30277861 DC : 0 BS EN 60335-2-111 ED 1.0 - HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-111: PARTICULAR REQUIREMENTS FOR ELECTRIC ONDOL MATTRESS WITH A NON-FLEXIBLE HEATED PART
    I.S. EN 60601-2-50:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT
    I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    CEI EN 60335-2-17 : 2013 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2: PARTICULAR REQUIREMENTS FOR BLANKETS, PADS, CLOTHING AND SIMILAR FLEXIBLE HEATING APPLIANCES
    UNE-EN 60335-2-17:2013 Household and similar electrical appliances - Safety - Part 2-17: Particular requirements for blankets, pads, clothing and similar flexible heating appliances
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    07/30164508 DC : 0 IEC 60601-2-21 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS
    14/30257546 DC : 0 BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
    BS EN 60335-2-17:2013 Household and similar electrical appliances. Safety Particular requirements for blankets, pads, clothing and similar flexible heating appliances
    I.S. EN 60335-2-17:2013 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-17: PARTICULAR REQUIREMENTS FOR BLANKETS, PADS, CLOTHING AND SIMILAR FLEXIBLE HEATING APPLIANCES (IEC 60335-2-17:2012 (EQV))
    I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
    ISO 17966:2016 Assistive products for personal hygiene that support users Requirements and test methods
    EN 60335-2-17:2013 Household and similar electrical appliances - Safety - Part 2-17: Particular requirements for blankets, pads, clothing and similar flexible heating appliances
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
    IEC 60335-2-17:2012+AMD1:2015 CSV Household and similar electrical appliances - Safety - Part 2-17:Particular requirements for blankets, pads, clothing and similar flexible heating appliances
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