• DD CEN/TS 14507-2:2003

    Current The latest, up-to-date edition.

    Inhalational nitric oxide systems Supply systems

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  11-04-2003

    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 Terminology
    5 General requirements
       5.1 R Safety
       5.2 R Alternative construction
       5.3 Materials
    6 Design requirements
       6.1 Components of the supply systems for
            nitric oxide
       6.2 Cylinders
       6.3 R Cylinder valves
       6.4 R Pressure regulators
       6.5 Pressure gauges
       6.6 R High-pressure flexible connections
       6.7 R Low-pressure hose assemblies
       6.8 Outlet connector of the supply system
       6.9 Quick-connectors
       6.10 Outlet pressure
       6.11 Alarms
       6.12 Flow
       6.13 Leakage
       6.14 R Change-over
       6.15 R Purging
       6.16 R Supporting structure
       6.17 R Stability
       6.18 R Rail system
       6.19 R Electrical components
       6.20 Back-up power supply
    7 Constructional requirements
       7.1 R Cleaning
       7.2 R Lubricants
    8 Test methods
       8.1 Ambient conditions
       8.2 Type tests of components
       8.3 Production tests of the supply system
    9 Marking and packaging
       9.1 Marking
       9.2 Packaging
    10 Information to be supplied by the manufacturer
    Annex A Rationale (Informative)
    Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to systems for the supply of nitric oxide/nitrogen mixtures to a delivery and monitoring system complying with CEN/TS 14507-1 for treatment of one patient at a time, in a healthcare facility.

    Scope - (Show below) - (Hide below)

    1.1 This Part of CEN/TS14507 applies to systems for the supply of nitric oxide/nitrogen mixtures to a delivery and monitoring system complying with CEN/TS14507‑1 for treatment of one patient at a time, in a healthcare facility.

    1.2 This Part of CEN/TS14507 applies to supply systems with cylinders at a filling pressure up to 20000kPa and concentrations up to 1000l/l of nitric oxide in nitrogen.

    1.3 R This Part of CEN/TS14507 does not apply to:

    • pipeline systems for delivery of nitric oxide/nitrogen mixtures to more than one patient at a time;

    • supply systems for nitric oxide/nitrogen mixtures intended for use in home care, emergency and transport.

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

    Committee CH/121/6
    Document Type Standard
    Publisher British Standards Institution
    Status Current

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

    EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    EN 12218:1998/A1:2002 RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT
    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
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    EN 962:1996/A2:2000 TRANSPORTABLE GAS CYLINDERS - VALVE PROTECTION CAPS AND VALVE GUARDS FOR INDUSTRIAL AND MEDICAL GAS CYLINDERS - DESIGN, CONSTRUCTION AND TESTS
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN 738-3:1998/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
    CR 13903:2000 General guidance on the equipment used for inhaled nitric oxide therapy
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 837-1:1996/AC:1998 PRESSURE GAUGES - BOURDON TUBE PRESSURE GAUGES - DIMENSIONS, METROLOGY, REQUIREMENTS AND TESTING
    EN 13221 : 2000 HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GASES
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