EN ISO 21969:2009
Current
The latest, up-to-date edition.
High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
11-01-2009
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
Annex ZA (informative) - Relationship between this
International Standard and
the Essential Requirements
of EU Directive 93/42/EEC
Bibliography
ISO 21969:2009 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.ISO 21969:2009 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.ISO 21969:2009 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.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 13221. (08/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 21969:2010 | Identical |
| I.S. EN ISO 21969:2009 | Identical |
| NF EN ISO 21969 : 2010 | Identical |
| BS EN ISO 21969:2009 | Identical |
| NS EN ISO 21969 : 2009 | Identical |
| NEN EN ISO 21969 : 2009 | Identical |
| DIN EN ISO 21969:2010-04 | Identical |
| UNI EN ISO 21969 : 2010 | Identical |
| NBN EN ISO 21969 : 2010 | Identical |
| ISO 21969:2009 | Identical |
| PN EN ISO 21969 : 2009 | Identical |
| SN EN ISO 21969 : 2010 | Identical |
| SS-EN ISO 21969 : 2009 | Identical |
| 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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