The EN ISO 18562-1 standard, developed by the International Organization for Standardization (ISO), covers the biological assessment of a medical device, its parts or accessories, within a risk management process, of gas pathways intended to provide respiratory care or to supply substances to a patient through the respiratory tract in all settings.
EN ISO 18562-1 General Principles
General categorization of gas paths according to the nature and duration of their contact with the gas flow,
Evaluation of relevant data available from all sources,
Identifying gaps in the existing dataset based on a risk analysis,
Identification of additional datasets necessary to analyze the biological safety of the gas pathway,
Evaluation of the biological safety of the gas path.
EN ISO 18562-1 covers general principles for the assessment of biocompatibility of medical device materials forming the gas path, but does not cover biohazards resulting from any mechanical failure unless the failure presents a risk of toxicity (for example, by creating particles). Other parts of ISO 18562 cover specific tests that address potentially hazardous substances added to the respirable gas stream and establish acceptance criteria for those substances.
EN ISO 18562-1 addresses possible contamination of the gas stream originating from the gas paths within the medical device, which can then be delivered to the patient.
EN ISO 18562-1 is valid for the expected service life of the medical device in normal use and takes into account the effects of any intended treatment or reprocessing.
EN ISO 18562-1 does not address the biological evaluation of surfaces of medical devices in direct contact with the patient. Requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts, or accessories that contain gas paths discussed in this document include, but are not limited to, ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen protective equipment, oxygen concentrators, nebulizers, low pressure hose assemblies. , humidifiers, heat and humidity exchangers, respiratory gas monitors, respiratory monitors, masks, mouthpieces, resuscitators, breathing tubes, respiratory system filters and Y-pieces, and respiratory accessories intended for use with such medical devices. The closed chamber of an incubator including the mattress and the inner surface of an oxygen hood are considered gas paths and are also covered in this document.
EN ISO 18562-1 does not address contamination already present in gas supplied from gas sources when medical devices are in normal use.
Future pieces may be added to address other relevant aspects of biological testing, including additional contamination that may result from the gas path due to the presence of drugs and anesthetic agents added to the gas stream.
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