The ISO 15001 standard, developed by the International Standards Organization (ISO), describes the requirements for the oxygen compatibility of materials, components and devices for anesthetic and respiratory applications that can come into contact with oxygen in the normal state or in the event of a single failure at gas pressures higher than 50 kPa. In addition, this standard contains general practices for conducting a risk analysis, including the selection of materials and components based on available data on oxygen compatibility, and the consideration of toxicity of combustion or decomposition products.
Compatibility aspects addressed by that standard include cleanliness, resistance to ignition, and toxicity of combustion or decomposition products during design, manufacture, maintenance and disposal.
The ISO 15001 standard applies to anesthetic and respiratory equipment within the scope of the ISO/TC 121 standard. For example, medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow meters, anesthesia workstations and lung ventilators are covered by this standard.
Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Clinic staff and patients in general are at risk of serious injury if a fire occurs in an oxygen-enriched atmosphere, as they are in close proximity to devices used with oxygen. This fire is usually caused by the heat produced by compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, such as some non-metals such as plastics, elastomers and lubricants, are toxic. Therefore, patients who are away from this equipment and receive oxygen from the medical gas pipeline system suffer when a problem occurs. Reducing or preventing these risks depends on the selection of suitable materials, cleaning methods and the correct design and manufacture of the equipment to be compatible with oxygen under the conditions of use.
This international standard contains recommendations for the selection of materials used in oxygen and oxygen-enriched environments and the cleaning of components made from them.
Our organization also provides anesthetic and respiratory equipment, oxygen compatibility testing services within the scope of ISO 15001 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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