Biocompatibility evaluation of breathing gas pathways in healthcare applications - Tests for leachables in condensate1 Scope This document specifies tests for substances leached by liquid water condensing into 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 tests of this document are intended to quantify hazardous water soluble substances that are leached from the medical device, its parts or accessories by condensate and

in accordance with ISO 5053-1

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A standard sample volume is used

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It is applicable to electrotechnical equipment

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