Manufacturing requirements for respiratory ventilators - clean room required?

#1
Hello Elsmar Cove community,

Does anybody here know if you are required to manufacture respiratory ventilators in a clean room? I could not find any specific requirements aside form ISO 13485 and CFR 820. I was asked by somebody who is interested in manufacturing emergency ventilators.

Thank you!
 
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blackholequasar

Involved In Discussions
#2
It would be best to check with the FDA directly (if they are manufacturing in the US). There doesn't seem to be a lot of information out there just yet on this. I certainly wish whoever it is well in their endeavor, I know we are in dire need of them!
 

Johnnymo62

Haste Makes Waste
#6
I don' think clean rooms are necessary, but following the Good Manufacturing Practices should be sufficient. They are not used internally.
 
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