• IEC 60601-2-38:1996

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 requirementsfor the safety of electrically operated hospital beds

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

    Superseded date:  10-12-2009

    Language(s): 

    Published date:  30-10-1996

    Publisher:  International Electrotechnical Committee

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

    Committees responsible
    National foreword
    Foreword
    Section 1 - General
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    5 Classification
    6 Identification, marking and documents
    Section 2 - Environmental conditions
    Section 3 - Protection against electrical shock hazards
    17 Separation
    18 Protective earthing, functional earthing and potential
          equalization
    Section 4 - Protection against mechanical hazards
    21 Mechanical strength
    22 Moving parts
    23 Surface, corners and edges
    24 Stability in normal use
    26 Vibration and noise
    28 Suspended masses
    Section 5 - Protection against hazards from unwanted or
                excessive radiation
    36 Electromagnetic compatibility
    Section 6 - Protection against hazards of ignition of
                flammable anaesthetic mixtures
    Section 7 - Protection against excessive temperatures and
                other safety hazards
    44 Overflow, spillage, leakage, humidity, ingress of
          liquids, cleaning, sterilization and disinfection
    Section 8 - Accuracy of operating data and protection against
                hazardous output
    Section 9 - Abnormal operation and fault conditions;
                environmental tests
    52 Abnormal operation and fault conditions
    Section 10 - Constructional requirements
    54 General
    56 Components and general assembly
    57 MAINS PARTS, components and layout
    Appendix L - References - Publications mentioned in this
                              standard
    Annex AA (informative) Guidance and rationale for particular
                           subclauses
    Annex BB (informative) Possible considerations and tests for
                           ELECTRICALLY OPERATED HOSPITAL BEDS
    Annex ZA (normative) Normative references to international
                         publications with their corresponding
                         European publications
    Figure 101 - ELECTRICALLY OPERATED HOSPITAL BED, general
                 arrangement
    Figure 102 - Distribution of the SAFE WORKING LOAD for tests
    Figure 103 - Lateral stability test: load arrangement (plan
                 view)
    Figure 104 - Longitudinal stability test: load arrangement
                 (plan view)
    Figure 105 - Lateral stability test: load arrangement (end
                 elevation)
    Figure 106 - Longitudinal stability test: load arrangement
                 (side elevation)
    Figure 107 - BED function controls and/or actuators;
                 guidelines for creating graphic symbols
    Figure 108 - Graphic symbols for SAFE WORKING LOAD
    Figure 109 - Typical spacings for SQUEEZING and SHEARING
                 POINTS
    Figure 110 - Clearance measurements around barriers
    Figure 111 - APPLIED PARTS region and potential equalization
    Figure 112 - Minimum angle between the back and leg/upper
                 leg sections for various configurations of the
                 MATTRESS SUPPORT PLATFORM
    Figure 113 - Application of forces for test of SIDE RAILS
    Figure 114 - Examples (only) of BEDS with segmented SIDE
                 RAILS and single-piece SIDE RAILS
    Figure 115 - Test cone
    Figure BB.1 - Impactor
    Figure BB.2 - Loading positions
    Figure BB.3 - Loading pad
    Figure BB.4 - Recommended range of adjustment for sections of
                  the MATTRESS SUPPORT PLATFORM
    Figure BB.5 - Position of the LIFTING POLE handle

    Abstract - (Show below) - (Hide below)

    Specifies requirements for safety of electrically operated hospitalbeds. The object of this standard is to keep the safety hazards topatients, operators and the environment as low as possible, and todescribe tests to verify that these requirements are attained.

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

    Development Note Also numbered as BS EN 60601-2.38 & BS 5724-2.38(1997) (10/2003)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

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

    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    I.S. EN 61219:1994 LIVE WORKING - EARTHING OR EARTHING AND SHORT-CIRCUITING EQUIPMENT USING LANCES AS A SHORT-CIRCUITING DEVICE - LANCE EARTHING
    EN 60601-2-52:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS
    EN 61219:1993 Live working - Earthing or earthing and short-circuiting equipment using lances as short-circuiting device - Lance earthing
    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
    DIN EN 1970:2005-10 ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    BS EN 60601-2-52 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS
    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)
    EN 1970:2000/A1:2005 ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
    EN 60601-2-52:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    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)
    I.S. EN 60601-2-52:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS (IEC 60601-2-52:2009)
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 1970:2000 Adjustable beds for disabled persons. Requirements and test methods
    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)
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    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)
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