FDA Cleanroom requirements for class II in vitro medical devices

[invitro_spain]

Hi all,

Does anybody have an idea about which ISO class is necessary for a in vitro medical devices class II Cleanroom?. More specifically,
I am thinking in Glucose test strips manufacturing cleanroom and the FDA requirements compliance in this matter.

I think the cleanroom could be a class 8 based on ISO 14644-1, but actually I am not sure.

What is your opinion? I need some feedback please.

Thank you in advance

Alberto

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!