DANSK DSF/ISO/FDIS 18562-4 PDF

This part of ISO 18562 specifies tests for the emissions of water-soluble substances from the GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care to a PATIENT in all environments. The tests of this International Standard are intended to quantify hazardous water-soluble substances that are emitted by the equipment and conveyed by liquid condensate to the PATIENT. This International Standard establishes acceptance criteria for these tests. This International Standard addresses potential contamination of the gas stream arising from the GAS PATHWAYS, which is then conducted to the PATIENT. This Standard applies over the EXPECTED SERVICE LIFE of the MEDICAL DEVICE in NORMAL USE, and should take into account the effects of any intended processing or reprocessing This International Standard does not address biological evaluation of the surfaces of GAS PATHWAYS that are in direct contact with the PATIENT. The requirements for direct contact surfaces are found in the ISO 10993 (series).