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  • UNE-EN ISO 21969:2010

    Current The latest, up-to-date edition.

    High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  05-05-2010

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Terminology
    5 General requirements
      5.1 Safety
      5.2 Alternative construction
      5.3 Materials
      5.4 Design requirements
      5.5 Constructional requirements
    6 Test methods
      6.1 General
      6.2 The type tests
    7 Marking, colour coding and packaging
      7.1 Marking
      7.2 Colour coding
      7.3 Packaging
    8 Information to be supplied by the manufacturer
    Annex A (informative) Rationale
    Bibliography
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC Medical devices

    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 25 000 kPa at 15 degree 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.

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

    Committee CTN 110
    Development Note Supersedes UNE EN 13221. (05/2007)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    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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