Guide To and Experience of ISO 18562

May 18, 2021
By M.Turner

MET has published details of our experience working with ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process.

The paper covers the testing requirements of parts 2, 3 and 4 of the standard. It helps manufacturers understand the requirements and approaches to completing the necessary studies.

Published in the May 2021 edition of ONdrug Delivery magazine the paper titled Biocompatibility of Medicinal Product Medical Device Combinations for Airway Delivery, the paper is helpful to suppliers of delivery devices including nebulisers, vapourisers and inhalers. It is also useful for helping to evaluate ventilators, breathing circuits, humidifiers, face masks and many other components of breathing equipment.

MET’s services encompass:

·       ISO 18562-1: Evaluation and testing within a risk management process

·       ISO 18562-2: Tests for emissions of particulate matter

·       ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs)

·       ISO 18562-4: Tests for leachables in condensate


The paper is also available as a download from this site.

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