• BS ISO 18835:2015

    Current The latest, up-to-date edition.

    Inhalational anaesthesia systems. Draw-over anaesthetic systems

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-04-2015

    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
    5 Draw-over vaporizer
    6 Breathing system
    7 Reservoir 8 Bellows-type manual ventilator
    9 Marking of operator-assembled components
    10 Information supplied by the manufacturer
    Annex A (informative) - Rationale
    Annex B (normative) - Test methods
    Annex C (informative) - Environmental aspects
    Annex D (informative) - Reference to the essential principles
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.

    Scope - (Show below) - (Hide below)

    It is understood, that at the time of writing this International Standard, flammable anaesthetic agents, such as diethyl ether, are still being used in certain countries where draw-over anaesthetic systems are in use. The use of monitoring is highly recommended and is the subject of the World Health Organization (WHO) guidelines, but was not considered essential with this intrinsically safe system of delivering inhalational anaesthesia. The unreliable supply of electricity and lack of resources for the continuous supply of consumables also render most monitors unsustainable. ISO8835-7:2011, 5 c) mandates that a means for the manual ventilation of the patient shall be included and refers to operator-powered resuscitators and inflating bellows. Operator-powered resuscitators are covered by ISO10651-4. However, as bellows-type manual ventilators do not have a standard, they have been included in this International Standard. A.4.4 Components for use with flammable anaesthetic agents An example of a flammable anaesthetic agent in use is diethyl ether. Examples of non-flammable anaesthetic agents are halothane and isoflurane. ISO80601-2-13:2011, AnnexB, provides details on the methods of test to determine the flammability of anaesthetic agents. A.5.2.2 Draw-over vaporizer — Accuracy of output Draw-over vaporizers are designed and calibrated to operate at or slightly below atmospheric pressure. The calibration might not be valid when the draw-over vaporizer is pressurized, for example, when used as a “push over?? vaporizer. A.5.3 Draw-over vaporizer — Ports and connectors A sequential system of cones and sockets has been adopted as all the major components of this draw-over anaesthetic system are flow-direction-sensitive. Such a system does not overcome the hazard of omitting a major component or of assembling components in the wrong order, but in view of the small number of components employed, this risk is considered acceptable. A.6.3.3 Breathing system — exhaust port A 30mm cone is specified at the exhaust port to facilitate connection to an anaesthetic gas scavenging system (AGSS) complying with ISO80601-2-13. It is not anticipated that a sophisticated AGSS will be a high priority, but simple steps such as attaching a hose to lead waste gases to floor level can substantially reduce levels of pollution at the breathing level of theatre staff. It is important that the instructions for use draw attention to the potential hazards in using non-anaesthetic proof gas (APG) category equipment with flammable agents [see 10 d) 7)]. A.7.1.2 reservoir — Instructions for positioning of the supplementary oxygen inlet The positioning of the supplementary oxygen inlet connector is crucial. It should be as close as possible to the outlet of the reservoir where the reservoir connects to the inlet of the draw-over vaporizer. If placed elsewhere, there will be an inefficient use of oxygen and the possibility of a build-up of pressure and alteration of vaporizer output. A.8.1 Bellows-type manual ventilator — Construction The draw-over anaesthetic system comprises, in its most basic form, a draw-over vaporizer and a breathing system. The breathing system mandates a draw-over valve system, which in itself, mandates that the patient must be able to inhale and exhale during both spontaneous and positive pressure ventilation. If a bellows-type manual ventilator is then introduced, these requirements still apply, and as written, will ensure that the patient can inhale and exhale while receiving positive pressure ventilation.

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    Committee CH/121/1
    Development Note Supersedes DD ISO/TS 18835 & 13/30272807 DC. (04/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 5360:2016 Anaesthetic vaporizers Agent-specific filling systems
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    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 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    ISO 8835-7:2011 Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
    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
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    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 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
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