NF EN ISO 18562-1:2020

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.