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9/2/2020 - ISO 18562, Safety of Breathable Gas, Tests Passed
09/03/2020 at 18:10 • 0 commentsMakerVent has passed ISO 18562 testing ! Final report and risk analysis will be back in a couple of weeks, but in a conference call with the testing lab, they have informed us that VOC analysis shows a very small number of compounds present, and all well within safe margins. We had already been informed that the particulate test had passed. So this ventilator will safely deliver breathable gas. This ventilator is one of the first, if not the first (it may be) to use off the shelf industrial automation, non-medical, components, and pass these safety of breathable gas tests - showing that with careful choice of materials, and expert cleaning (check out our team page, http://MakerVent.com/team to learn more about the cleaning lab), ventilators can be built like this and safely deliver breathable gas. An important milestone !!!
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8/31/2019 ISO 18562 testing complete
08/31/2020 at 22:25 • 0 commentsParticulate test complete and results reviewed, the ventilator passed !
VOC (volatile organic compounds) tests completed, samples still awaiting detailed analysis, at testing lab.
Getting professional regulatory and quality management assistance for the request to the FDA for authorization for use in the Covid-19 pandemic. Steady progress on documentation and creation of audit-able assembly and test procedures. We have built two here in Arizona so far.
The machine is solid, and in fact one of our team members in London UK has built his own version of the ventilator, in a different enclosure, but the same basic design and components, which he is using to characterize pressure and volume profiles, and other facets of ventilator operation.
Much more news and information at http://MakerVent.com !
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Oxygen cleaning complete, ISO 18562 testing begins
07/05/2020 at 01:14 • 0 comments7/3/2020 - The ventilator has been oxygen-cleaned, and sent to a lab for ISO 18562 (safety of breathable gas) testing.
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5/19/2020
05/20/2020 at 04:42 • 0 commentsPreparing to have parts oxygen cleaned, then will submit machine to testing lab for ISO 18562 (safety of breathable gas) testing.