Surgical masks ( type IIR) - Cleanroom Requirements

pfcustodio

Registered
Hi to all.

My manager wants to put the company manufacturing surgical masks ( type IIR), classied as medical devices, class I.

I have experience with medical devices and I know we need to create a technical file for the produt.

We have the standard (ISO 14683:2019), so we are aware of the tests requirements.

But I have one doubt and I can't find an answer. Is mandatory to have a cleanroom (ISO 8) to produce the surgical masks?

Thanks in advance.
 

planB

Super Moderator
As long as you can meet the required cleanliness requirements (including, but not limited to microbial cleanliness), it is to mandatory to produce in a cleanroom. Note that ISO 14683:2019 does not cover requirements for the manufacturing process (at least for the purpose of the European MDD): DIN EN 14683:2019-10 says in Table ZA.1 "Die Gestaltung des Herstellungsprozesses ist nicht abgedeckt."

HTH,
 

pfcustodio

Registered
Thanks for the reply.

To be clear, you meant to say "it is not mandatory to produce...", right? I think there is a typo.

Also, I made some research and the information I got is that for non sterile devices, the GMP indicates that is not mandatory a cleanroom.

Again, thanks for the information.
 

planB

Super Moderator
Sorry for the misleading typo - you are correct: "[...] it is not mandatory to produce in a cleanroom."
 
Top Bottom