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Rule 19 nanoparticle antibacterial coatings

ISO 13485 & EU MDR
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Guest user Created:   Mar 07, 2022 Last commented:   Mar 09, 2022

Rule 19 nanoparticle antibacterial coatings

ISO 13485 & EU MDR
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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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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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Mar 07, 2022

Mar 09, 2022

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