Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process Ingestion-build-89079 Bar code and 2D symbol

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Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process Ingestion-build-89079 Bar code and 2D symbol1 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