Surgical masks ( type IIR) - Cleanroom Requirements

P

pfcustodio

Registered
#1
#1
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.
 
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planB

planB

Super Moderator
#2
#2
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,
 
P

pfcustodio

Registered
#3
#3
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.
 
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