• I.S. EN ISO 8835-2:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: ANAESTHETIC BREATHING SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-01-2013

    Language(s):  English

    Published date:  01-01-2009

    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
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General
       4.1 Materials
       4.2 Anaesthetic breathing system component
            packaging
       4.3 Electrical requirements
       4.4 Alternative test methods
    5 Connection ports
       5.1 Patient connection port
       5.2 Y-Piece
       5.3 Exhaust connection port
       5.4 Interchangeable non-rebreathing exhaust valves
       5.5 Reservoir bag connection port
       5.6 Anaesthetic ventilator connection port
       5.7 Connection ports of interchangeable anaesthetic
            breathing system components
       5.8 Inspiratory and expiratory connection ports of an
            interchangeable circle absorber assembly
       5.9 Other connection ports
    6 Reservoir bag/anaesthetic ventilator selector
       switch
    7 Complete anaesthetic breathing system either
       supplied assembled or assembled in accordance
       with the manufacturer's instructions
       7.1 Leakage
       7.2 Inspiratory and expiratory pressure/flow
            characteristics
    8 Interchangeable anaesthetic breathing system
       components - Exhaust valves
       8.1 Direction of movement of controls
       8.2 Pressure/flow characteristics
       8.3 Opening pressure
       8.4 Leakage
    9 Circle absorber assemblies
       9.1 Construction
       9.2 Absorbent bypass mechanism
       9.3 Pressure/flow characteristics
       9.4 Inspiratory and expiratory valves
    10 Pressure monitoring and limitation
       10.1 Pressure monitor
       10.2 Pressure-limiting device
    11 Location of components in an anaesthetic breathing
       system containing a circle absorber assembly
       (as defined in 3.3)
       11.1 Exhaust valve
       11.2 Reservoir bag connection port
       11.3 Fresh gas inlet
       11.4 Inspiratory and expiratory valves
    12 Marking
       12.1 Marking of complete anaesthetic breathing
            systems and anaesthetic breathing system
            components
       12.2 Marking of packages
    13 Information to be provided by the manufacturer or
       supplier
       13.1 General
       13.2 For anaesthetic breathing systems supplied
            complete
       13.3 For anaesthetic breathing system components
    Annex A (normative) - Typical test arrangements and
            methods
    Annex B (informative) - Rationale
    Annex C (informative) - Environmental aspects
    Annex D (normative) - Antistatic requirements
    Bibliography
    Annex ZA (informative) - Relationship between this
             Standard and the Essential Requirements of
             EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions.

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

    Development Note Together with I.S. EN ISO 8835-3, I.S. EN ISO 8835-4 and I.S. EN ISO 8835-5 supersedes I.S. EN 740. (09/2007)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

    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
    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
    ISO/TS 18835:2004 Inhalational anaesthesia systems Draw-over vaporizers and associated equipment
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and 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 5362:2006 Anaesthetic reservoir bags
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    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 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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