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BS EN ISO 21969:2009

Current

Current

The latest, up-to-date edition.

High-pressure flexible connections for use with medical gas systems

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-03-2010

€156.59
Excluding VAT

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
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Pertains to high-pressure flexible connections intended to be connected to cylinders or cylinder bundles with nominal filling pressures up to 25000 kPa at 15 degrees 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.

Committee
CH/121/6
DevelopmentNote
Supersedes BS EN 13221. (04/2007)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

1.1

This International Standard 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.

1.2

This International Standard 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.

1.3

This International Standard 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.

1.4

This International Standard does not apply to high-pressure flexible connections intended to be used to fill cylinders nor does it apply to low-pressure flexible hose assemblies that are covered by ISO 5359.

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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