ÖNORM EN ISO 18562-1:2020 06 01
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Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)
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German - English
06-01-2020
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.
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