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. ISO 15001-1:2004 certification is a standard that gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility with anesthetic and respiratory equipment, 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 15001 include cleanliness, resistance to ignition, and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance, and disposal stages. ISO 15001-1:2004 certification does not apply to biocompatibility.
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