Confusion about ISO 14644

#1
Hi everyone,

We're a medical device company currently undergoing MDR certification and something that came up in our non-conformities is ISO standards 14644-2, -8, -9 and -10 not being referred to within our GSPR.

We currently conform to ISO 14644-1 and have an ISO Class 5 clean room but are unsure how the above standards are applicable.

I've also noted within 14644-8 that it "is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process". Am I correct in thinking that since we do not use chemical substances within our cleanroom (nor do we use chemicals for manufacturing, only polymers) that this standard would not apply to us?

Would appreciate some guidance.

Thanks
 
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chris1price

Trusted Information Resource
#2
I would expect ISO14644-2 (monitoring in cleanrooms) to be relevant. Which part of the GSPR did the auditor reference concerning the other parts?
 

Ronen E

Problem Solver
Moderator
#3
Class 5 is an extremely stringent classification for medical devices manufacturing. What kind of devices are we talking about?

Do you have a legal copy of the latest ISO 14644-1 revision?

How do you know you conform if you don't apply ISO 14644-2?

WRT your quote from ISO 14644-8 (which I don't have, so just going for now with your quote, as given), "the presence of airborne chemical substances is not considered a risk" doesn't speak of whether or not such airborne chemical substances are present; but rather of whether they would be considered a risk if they were in fact present (or could be present). My take on that phrase is that part 8 would be N/A in cases where their presence wouldn't be considered a risk even if they were there, i.e. where the product/process is totally insensitive to such substances. Is that your case? Additionally, the fact that you don't intentionally employ them doesn't guarantee that they're not there - consider all potential sources, including unintentional/accidental.
 
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