D
d.conroy
We are a surgical instrument (class 1) reusable medical device developer/manufacturer.
The instrument is machined in a manufacturing environment, passivated, cleaned and then packed. The device is cleaned and sterilized in the hospital before each use. The cleaning and sterilization process that we instruct the hospital to complete is validated.
From reading iso 13485 I think section b) of 7.5.2 applies to our device but I'm not sure what level of cleanliness we require and the subsequent validation requirements of our factory cleaning process.
My opinion is that the device is cleaned by the user and that the factory cleaning process is not critical.
I could specify a required cleanness level as " free from visual particulate and contamination under x2 magnification". This would mean we could 100% verify the parts and not complete any validation of our factory cleaning process.
Will this be accepted? Any hep?
The instrument is machined in a manufacturing environment, passivated, cleaned and then packed. The device is cleaned and sterilized in the hospital before each use. The cleaning and sterilization process that we instruct the hospital to complete is validated.
From reading iso 13485 I think section b) of 7.5.2 applies to our device but I'm not sure what level of cleanliness we require and the subsequent validation requirements of our factory cleaning process.
My opinion is that the device is cleaned by the user and that the factory cleaning process is not critical.
I could specify a required cleanness level as " free from visual particulate and contamination under x2 magnification". This would mean we could 100% verify the parts and not complete any validation of our factory cleaning process.
Will this be accepted? Any hep?