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Acceptable Materials for Breathing Tube

Acceptable Materials for Breathing Tube

(OP)
Hello,
Not sure where this question should go, please feel free to point me elsewhere.

I am designing a product that users will breath through. I want to make sure it is safe for the user and it is not going to deteriorate over time if saliva gets into it.

What is a good source for tubing, that is in Canada or at least ships to Canada?

Are there standard materials I should use?

Are there bad materials I should avoid?

Are there standards or certifications I should look for?

Thanks.

RE: Acceptable Materials for Breathing Tube

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.

RE: Acceptable Materials for Breathing Tube

(OP)
Thank you for the reply. I found some tubing that says it meets USP Class VI. That sounds like it is sufficient. Can you think of anything else I should look for?

RE: Acceptable Materials for Breathing Tube

Is this part of a medical device? You should look into ISO 10993.

You should look at what is necessary to clear your device through Health Canada as well as FDA, as this may include biocompatibility testing of the material you are using. Not many material suppliers provide biocomp data.

There are consulting firms who specialize in this sort of thing and they could offer you the best guidance.

RE: Acceptable Materials for Breathing Tube

(OP)
For now it is just a toy. Could that also have to go through Health Canada and FDA?

Do you know any good firms that you could recommend?

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