ISO 15000-1:2004 Certification

ISO 15000-1:2004 certification is the standard certification that specifies requirements for the oxygen compatibility of materials, components, and devices for anesthetic and respiratory applications, which can come into contact with oxygen in normal conditions or single fault condition at gas pressures greater than 50 kPa. The anesthetic and respiratory equipment include breathing attachments and anesthetic machines, airways and related equipment, respiratory devices and related equipment used for patient care, medical gas supply systems, suction devices, connectors for respiratory therapy devices, and accessories.

Requirements have been recorded for the level of hydrocarbon and particle contamination and the resistance to ignition and risk management. The normative part is supplemented by extensive informative annexes with examples of cleaning procedures including their validation, with explanations of the design of oxygen-containing systems, with information on the materials and a recommended test method for the combustion and quantitative analysis of the combustion products of non-metallic materials. 

ISO 15000-1:2004 certification also gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition. Aspects of compatibility that are addressed by ISO 15000-1:2004 include cleanliness, resistance to ignition, and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance, and disposal stages. ISO 15000-1:2004 does not apply to bio compatibility. It applies to anesthetic and respiratory equipment e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anesthetic workstations, and lung ventilators. 

Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire occurs in an oxygen-enriched atmosphere. A common cause of the fire is the heat produced by adiabatic compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, especially some non-metals (e.g. plastics, elastomers, and lubricants) are toxic and thus patients remote from that equipment and who are receiving oxygen from a medical gas pipeline system might be injured when a problem occurs. Other equipment that is in close proximity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to function properly if there is a problem with the oxygen equipment.

Reduction or avoidance of these risks depends on the choice of appropriate materials, cleaning procedures, and correct design and construction of equipment so that it is compatible with oxygen under the conditions of use. ISO 15000-1:2004 gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres. It is expected that particular device standards will make reference to this horizontal International Standard and may, if appropriate, strengthen these minimum requirements. Particular device standards may specify that some requirements of this International Standard may apply for medical gases other than oxygen. This International Standard gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres.