DANSK DSF/ISO/FDIS 18562-2 PDF

This part of ISO 18562 specifies tests for the emissions of PARTICULATE MATTER 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 particles from 0,2 μm diameter to 10 μm diameter that are emitted by the equipment into the respirable gas stream. This International Standard establishes acceptance criteria for these tests. This Standard does not address nanoparticles. Insufficient data exists to establish exposure limits for particles less than 0,2 μm in DIAMETER. NOTE – Smaller and larger particles could also present biological hazards, and additional information outside the scope of this standard can be needed to meet requirements of some authorities having jurisdiction. This International Standard addresses potential contamination of the gas stream arising from the GAS PATHWAYS, which is then conducted to the PATIENT.