This document 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 or supply substances via the respiratory tract to a PATIENT in all environments. The tests of this document are intended to quantify particles from 0,2 µm DIAMETER to 10 µm DIAMETER that are emitted by the MEDICAL DEVICE, its parts or ACCESSORIES into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 µm in DIAMETER.

Cross References:
ISO 14971:2007
ISO 7396-1:2016
ISO 18562-1:2017
ISO 16000-37:2019
BS ISO 16000-37:2019
ISO 16142-1:2016
ISO 10993
ISO 7708:1995


Incorporates the following:
Corrigendum, February 2020