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CEN/TS 14507-2 : 2003

Current
Current

The latest, up-to-date edition.

INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS
Published date

26-03-2003

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

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.

Committee
TC 215
DocumentType
Technical Specification
PublisherName
Comite Europeen de Normalisation
Status
Current

I.S. CEN/TS 14507-1:2003 INHALATIONAL NITRIC OXIDE SYSTEMS - PART 1: DELIVERY SYSTEMS

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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
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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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