• UNI EN ISO 8835-3 : 2010

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS

    Available format(s): 

    Superseded date:  20-02-2013

    Language(s): 

    Published date:  31-12-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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 alternative test methods
    5 Patient and environmental protection
    6 Connectors
    7 Transfer systems
    8 Receiving systems
    9 Extract flow resistance
    10 Electrical requirements
    11 Information to be supplied by the manufacturer
    12 Marking
    13 Colour coding
    Annex A (informative) - Typical test arrangement and method
       for pressure measurement at inlet to AGSS
    Annex B (informative) - Typical test arrangement and method
       for sub-atmospheric pressure limitation
    Annex C (informative) - Typical test arrangement and method
       for testing of induced flow
    Annex D (informative) - Typical test arrangement and method
       for resistance to extract flow
    Annex E (informative) - Typical test arrangement and method
       for spillage
    Annex F (informative) - Rationale
    Annex G (informative) - Environmental aspects
    Annex ZA (informative) - Relationship between this European
       Standard and the Essential Requirements of EU Directive
       93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure). Also describes requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

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

    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By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
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    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 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
    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 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
    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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