• I.S. EN 60601-2-38:1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ELECTRICALLY OPERATED HOSPITAL BEDS

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-04-2010

    Language(s):  English

    Published date:  01-01-1998

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    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
    Annexes
    L References - Publications mentioned in this standard
    AA (informative) Guidance and rationale for particular
                     subclauses
    BB (informative) Possible considerations and tests for
                     ELECTRICALLY OPERATED HOSPITAL BEDS
    Annex ZA (normative) Normative references to international
                         publications with their corresponding
                         European publications

    Abstract - (Show below) - (Hide below)

    Gives requirements for safety of ELECTRICALLY OPERATED HOSPITAL beds.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 2204:1979 Acoustics Guide to International Standards on the measurement of airborne acoustical noise and evaluation of its effects on human beings
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for 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
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 14971-1:1998 Medical devices Risk management Part 1: Application of risk analysis
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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