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Rule 19 nanoparticle antibacterial coatings
When does Rule 13 apply and when does Rule 19 apply? We have a nanoparticle coating for endotracheal tubes.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Mar 09, 2022
All medical devices which have nanoparticles are classified according to rule 19. If you are a manufacturer of nanocoating material that some other manufacturers put on the endotracheal tube, in that case, you do not have a medical device. Nanoparticle coating is not a medical device alone.
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