NEN-EN-ISO 18562-1:2020
Current
The latest, up-to-date edition.
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
Hardcopy
English
03-01-2020
NEN-EN-ISO 18562-1 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, whichare 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.
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