The ISO 18562 standard, developed by the International Standards Organization (ISO), consists of four parts under the main title "Biocompatibility assessment of respiratory gas tracts in health applications":
The first part of the ISO 18562 standard contains general principles for the biocompatibility assessment of medical device materials forming the gas path. However, biological hazards resulting from any mechanical failure are not covered by this standard unless the failure poses a risk of toxicity. Other parts of this standard contain specific tests that address potentially hazardous substances added to the respirable gas stream and establish acceptance criteria for those substances.
The second part of the ISO 18562 standard provides tests for particulate matter emissions from the gas paths of a medical device, its parts or accessories intended to supply substances to a patient through respiratory care or the respiratory tract in all settings. These tests aim to determine the amount of particles from 0,2 µm in diameter to 10 µm in diameter emitted into the respirable gas stream by the medical device, its parts or accessories.
The third part of the ISO 18562 standard describes test methods for emissions of volatile organic compounds (VOC) from the gas tracts of parts or accessories of a medical device designed to provide respiratory care or to provide a substance to a patient through the respiratory tract.
Section four of the ISO 18562 standard describes test methods for substances that condense into the gas passages of a medical device, its parts or accessories and are subsequently carried by liquid water to the patient for respiratory care or for supplying the substance to a patient via the respiratory tract in all settings. These tests aim to determine the quantity of water-soluble hazardous substances that condense from the medical device, its parts or accessories and are then carried to the patient by this liquid.
Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides testing services for the biocompatibility assessment of respiratory gas tracts in health applications within the scope of ISO 18562 standard, with its trained and expert staff and advanced technological equipment.
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