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UNE-EN ISO 21969:2010

Current

Current

The latest, up-to-date edition.

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

05-05-2010

€81.60
Excluding VAT

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
Asociacion Espanola de Normalizacion
Status
Current
Supersedes

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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