• BS EN ISO 18779:2005

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Medical devices for conserving oxygen and oxygen mixtures. Particular requirements

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-11-2020

    Language(s):  English

    Published date:  24-03-2005

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements and general requirements for
        tests
    5 Classification
    6 Identification, marking and documents
    7 Power input
    8 Basic safety categories
    9 Removable protective means
    10 Environmental conditions
    11 Not used
    12 Not used
    13 General
    14 Requirements related to classification
    15 Limitation of voltage and/or energy
    16 Enclosures and protective covers
    17 Separation
    18 Protective earthing, functional earthing and potential
        equalization
    19 Continuous leakage currents and patient auxiliary
        currents
    20 Dielectric strength
    21 Mechanical strength
    22 Moving parts
    23 Surfaces, corners and edges
    24 Stability in normal use
    25 Expelled parts
    26 Vibration and noise
    27 Pneumatic and hydraulic power
    28 Suspended masses
    29 X-Radiation
    30 Alpha, beta, gamma, neutron radiation and other particle
        radiation
    31 Microwave radiation
    32 Light radiation (including lasers)
    33 Infrared radiation
    34 Ultraviolet energy
    35 Acoustical energy (including ultrasonics)
    36 Electromagnetic compatibility
    37 Locations and basic requirements
    38 Marking and accompanying documents
    39 Common requirements for category AP and category APG equipment
    40 Requirements and tests for category AP equipment, parts and
        components thereof
    41 Requirements and tests for category APG equipment, parts and
        components thereof
    42 Excessive temperatures
    43 Fire prevention
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
        cleaning, sterilization, disinfection and compatibility
    45 Pressure vessels and parts subject to pressure
    46 Human errors
    47 Electrostatic charges
    48 Biocompatibility
    49 Interruption of the power supply
    50 Accuracy of operating data
    51 Protection against hazardous output
    52 Abnormal operation and fault conditions
    53 Environmental tests
    54 General
    55 Enclosures and covers
    56 Components and general assembly
    57 Mains parts, components and layout
    58 Protective earthing - Terminals and connections
    59 Construction and layout
    101 Additional requirements
    Annex AA (informative) Rationale
    Annex BB (informative) Environmental aspects
    Annex CC (informative) Index of defined terms
    Bibliography
    ANNEX ZA (informative) Relationship between this International
             Standard and the Essential Requirements of EU Directive
             93/42 EEC Medical devices

    Abstract - (Show below) - (Hide below)

    Describes requirements for oxygen and oxygen mixture saving devices (called here conserving devices) that are used to supply respiratory gases during therapy.

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

    Committee CH/121/5
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    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 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    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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