BS EN ISO 18562-1:2020 PDF

1   Scope 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