Biocompatibility evaluation of breathing gas pathways in healthcare applications - Tests for emissions of particulate matter
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Tests for emissions of particulate matter
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1 Scope 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 .
NOTE 1 Smaller and larger particles could also present biological hazards , and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction .
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
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