Standards

I'm working on a project to validate a compressed air system for a medical device manufacturer and came across ISO 8573 for Compressed Air.  While ISO 8573-1 does a good job at specifying the requirements for various purity classes for particles, water & oil, it leaves it up to the user to determine what they need to certify to.  I cannot seem to find any recommendations/requirements as to what purity classes a medical device manufacturer should validate to.  The best I have been able to find a filter manufacturer indicating that medical device companies typically validate to 2.2.1 or 2.1.1 (purity classes for particles, water & oil).  Any help would be appreciated.

I would think that one size does not fit all.

It depends upon what class and type of device is being manufactured.

If it is sterile or implantable, the acceptable contaminant level will be quite low, unless there is a subsequent cleaning/decontamination step.

I suggest that you contact your RA folks, find out how it is being regulated, and consider soliciting their help finding the appropriate requirement.

Best practice is going to be to do the risk analysis for your specific situation; the purity requirement will be the resulting risk control for the identified hazard.

GM Samaras