We Have Published a White Paper Describing Our Experience with ISO 18562

Mar 8, 2021

By M.Turner

At MET we have been testing to ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process, for three years now. We have written a paper to summarise our experience with the standard.

The standard is published in four parts. Each part is explained along with some information on the how studies have evolved in relation to the particulate testing described in part 2, the VOC testing given in part 3 and leachate testing given in part 4 of the standard. Also described is the need for toxicological risk analysis and an explanation of why inorganic gas testing is sometimes required.

These services form part of a complete programme of biocompatibility testing available in our labs.

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

Toxicological Risk Assessments

Extractables and Leachables

Complete ISO 10993 Testing

Chemical Characterisation

Biological Evaluation Plans and Reports.

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