• BS EN ISO 8835-5:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Inhalational anaesthesia systems Anaesthesia ventilators

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-02-2013

    Language(s):  English

    Published date:  31-07-2009

    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
    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 Infra-red radiation
    34 Ultraviolet radiation
    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 for anaesthetic ventilators
    102 Appendices of IEC 60601-1:1988
    Annex AA (informative) - Rationale
    Annex BB (normative) - Test for flammability of anaesthetic
             agents
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes particular requirements for the essential performance of anaesthetic ventilators.

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

    Committee CH/121/1
    Development Note Supersedes 01/561641 DC. To be read in conjunction with BS EN 60601-1. (08/2004) Together with BS EN 60601-2-13, BS EN ISO 8835-2 and BS EN ISO 8835-4 supersedes BS EN 740 and BS 5724-2.204(1999). (12/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 5145:2014 Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    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 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    IEC 60079-11:2011 Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
    IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
    ISO 10524:1995 Pressure regulators and pressure regulators with flow-metering devices for medical gas systems
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    ISO 5358:1992 Anaesthetic machines for use with humans
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
    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
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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