scope:

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.