ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control

[djc4388]

Hello All,

So the new requirement in section 7.5.2(c) says that I should have requirements for cleanliness of product or contamination control if "product cannot be cleaned prior to sterilization or it's use, and cleanliness is of significance in use". Do my current requirements for product to be manufactured in an ISO 8 cleanroom suffice? Or is this looking for something else entirely? Any feedback would be appreciated!

 

[Mark Meer]

If you've determined that ISO 8 requirements are sufficient/appropriate to your product, then yes specifying this as requirement is, IMO, sufficient to establish your cleanroom requirements (again, assuming this is deemed sufficient, and there are no additional requirements or deviations from the standard).

That being said, I would presume that you've also documented:

- Your rationale (e.g. in risk management documentation)​

- All the subsequent controls for demonstrating compliance, and ensuring that the environment is monitored & maintained​

 

[djc4388]

If you've determined that ISO 8 requirements are sufficient/appropriate to your product, then yes specifying this as requirement is, IMO, sufficient to establish your cleanroom requirements (again, assuming this is deemed sufficient, and there are no additional requirements or deviations from the standard).

That being said, I would presume that you've also documented:

- Your rationale (e.g. in risk management documentation)​

- All the subsequent controls for demonstrating compliance, and ensuring that the environment is monitored & maintained​

Great - thank you for your response!