BS EN ISO 18562-1:2020

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 <span style="font-variant: s...