Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

This document specifies tests for substances leached by liquid water condensing in 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 chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.

This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient.

This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.

This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories co