DS/EN ISO 18562-1:2024

This document specifies: – the general principles governing the biological evaluation within a risk management process of 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 general categorization of gas pathways based on the nature and duration of their contact with the gas stream; – the evaluation of existing relevant data from all sources; – the identification of gaps in the available data set on the basis of a risk analysis; – the identification of additional data sets necessary to analyse the biological safety of the gas pathway; – the assessment of the biological safety of the gas pathway.