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)
Hardcopy , PDF
Spanish, Castilian, English
05-05-2010
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
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.
| Committee |
CTN 110
|
| DevelopmentNote |
Supersedes UNE EN 13221. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| 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 |
| NBN EN ISO 21969 : 2010 | Identical |
| ISO 21969:2009 | Identical |
| 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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