• BS EN ISO 21969:2009

    Current The latest, up-to-date edition.

    High-pressure flexible connections for use with medical gas systems

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2010

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Terminology
    5 General requirements
    6 Test methods
    7 Marking, colour coding and packaging
    8 Information to be supplied by the manufacturer
    Annex A (informative) - Rationale
    Bibliography
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Pertains to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25000 kPa at 15 degrees C for use with the following medical gases: - oxygen; - nitrous oxide; - air for breathing; - helium; - carbon dioxide; - xenon; - mixtures of the gases listed above; - air for driving surgical tools; - nitrogen for driving surgical tools; - oxygen-enriched air.

    Scope - (Show below) - (Hide below)

    1.1

    This International Standard applies to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25 000 kPa at 15 °C for use with the following medical gases:

    • oxygen;

    • nitrous oxide;

    • air for breathing;

    • helium;

    • carbon dioxide;

    • xenon;

    • mixtures of the gases listed above;

    • air for driving surgical tools;

    • nitrogen for driving surgical tools;

    • oxygen-enriched air.

    1.2

    This International Standard applies to high-pressure flexible connections intended to connect cylinders or cylinder bundles to manifolds within sources of supply of medical gas pipeline systems complying with ISO 7396-1.

    1.3

    This International Standard applies to high-pressure flexible connections intended to connect a cylinder to an inlet port of medical equipment (e.g. anaesthetic workstation or lung ventilator) fitted with an integral pressure regulator complying with ISO 10524-1.

    1.4

    This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359.

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

    Committee CH/121/6
    Development Note Supersedes BS EN 13221. (04/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    CGA E 9 : 2017 STANDARD FOR ETFE-LINED AND PTFE-LINED FLEXIBLE HOSES FOR COMPRESSED GAS SERVICE
    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
    ISO 5145:2014 Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 7291:2010 Gas welding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 30 MPa (300 bar)
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    ISO/TR 7470:1988 Valve outlets for gas cylinders — List of provisions which are either standardized or in use
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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