DD CEN/TS 14507-2:2003
Current
The latest, up-to-date edition.
Inhalational nitric oxide systems Supply systems
Hardcopy , PDF
English
11-04-2003
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 |
CH/121/6
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| Standards | Relationship |
| CEN/TS 14507-2:2003 | Identical |
| DIN CEN/TS 14507-2:2003-08 | Equivalent |
| I.S. CEN/TS 14507-2:2003 | Equivalent |
| 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 13221 : 2000 | HIGH-PRESSURE FLEXIBLE CONNECTIONS FOR USE WITH MEDICAL GASES |
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