BS EN ISO 18562-4:2020

1   Scope This document specifies tests for substances leached by liquid water condensing into 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 hazardous water-soluble substances that are leached from the medical device , its parts or accessories by condensate and then conveyed by that liquid to the patient . 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 patient . The requirements for direct contact surfaces are found in the ISO 10993 series.

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