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GliaX / faceshield

Face shield personal protective equipment (PPE)
https://glia.org/covid-19/
GNU General Public License v3.0
100 stars 24 forks source link

Question about quality/standards #15

Open claraphilli opened 4 years ago

claraphilli commented 4 years ago

This is fantastic work. I work on 3D printing projects at a healthcare facility in Toronto and would love to start making these. I'm wondering if there are any standards (by Health Canada or other certifications) that these shields need to meet before they are used?

bborshan commented 4 years ago

Hi, yes this is a great project. To add to Clara's question, what 3D printing materials can be used, that would be compatible with the decontamination procedure?

tareko commented 4 years ago

This is a Class I device, so Health Canada's standards apply to the manufacturing facility and distributing company rather than to each individual device. Glia's stuff is all produced in a Health-Canada licensed facility (we hold an MDEL from them), and of course we follow all the protocols.

I'm not sure if everything is on there, but you should see almost everything, including our inspection a few months ago at the meta repo: https://github.com/gliax/meta

tareko commented 4 years ago

@bborshan: We recommend only PETG and ABS.

bborshan commented 4 years ago

@bborshan: We recommend only PETG and ABS.

OK thank you tareko!

claraphilli commented 4 years ago

Thank you!! Sorry I may not be asking the right question here, but if another facility would like to use your designs and follow the same protocols you provide, then what exactly are the Health-Canada implications?

tareko commented 4 years ago

If you want to have your own Health Canada certification, take a look at this email from HC. TL;DR: It's a 24 hour turn around now.

If you don't want to do that, what we would do is take the 3D prints from you and 'produce' the end device in London (Ontario), then send it back out. Inefficient, yes, but Health Canada compliant.

claraphilli commented 4 years ago

Thank you - this is very helpful!

volpex-industries commented 4 years ago

@bborshan: We recommend only PETG and ABS.

Is that just because of strength and flexibility requirements, or are there other reasons? We were hoping to use PLA and heat-treat it after printing to make it stronger and less brittle.

bborshan commented 4 years ago

Yes good point volpex-ind. I was curious about this as well. I've done some searching online, and it's more anecdotal experience from other 3d printers. It seems, for one thing, PETG can take soaking in concentrated bleach/chlorine a lot better than PLA. When disinfecting PLA parts, it's not clear how many times you can soak them before they start to degrade. But I would like to know more as well, because I could print PLA but not so much ABS or PETG. Thanks