BS EN ISO 18562-3:2020 PDF

Scope: 1 Scope This document specifies tests for the emissions of volatile organic compounds ( voc s) 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 emissions of voc s that are added to the respirable gas stream by the materials of the gas pathway . This document establishes acceptance criteria for these tests. This document addresses potential contamination of the gas stream arising from the gas pathways , which is then conducted to the patient . This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing. This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the

BS EN ISO 18562-3:2020 history

2020 BS EN ISO 18562-3:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Tests for emissions of volatile organic compounds (VOCs)