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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
PUBLISHED
SRPS EN ISO 21969:2011
60.60
Standard published
Jan 31, 2011