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Medical Device Label Acceptance Criteria

#1
Hello there - I work at a company that makes a class 2 single use medical device. We are investigating our label printing process and are trying to benchmark what acceptance criteria other companies/organizations use for their product labeling. The regulations mainly state that the labels must remain intact/legible during shipping, handling, and use, so I understand the regs. However, the regs aren't specific to state "only scratches 1" by 1" are ok" or "missing print must not exceed 0.5" in diameter".

My questions is: Can anyone point me to some acceptance criteria that other orgs use for med device labels?

Currently my company only allows very small scratches and missing ink and am wondering if we are being too stringent with our requirements. All of our labels are customer facing.
 
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yodon

Staff member
Super Moderator
#2
I'm not exactly a labeling expert but I'll toss in my 2 cents and maybe get the ball rolling.

I've never seen anything for label acceptability other than, as you say, legible (and that barcode is readable). What I generally see is, during a manufacturing run, to capture (a copy of) the first and last label as a level of evidence that the labels were good. If you are able, a vision system on the line checking each one is obviously best.

I would worry about "missing ink" since that could potentially cause a barcode read failure (worst case).
 

indubioush

Quite Involved in Discussions
#3
I suggest that you specification says "no scratches or missing ink." It isn't that difficult to make a pristine label print that is able to withstand shipping, etc. Are you using outdated label printing equipment or supplies? Your specification should show an example label as a standard to judge label prints. I would not want any labels with scratches or missing print to be seen by customers. Other things that should be looked at are size, color, barcode verification, font type, label stock, and probably other stuff that is not coming to mind...
 
#4
Thank you both for your insight. I have extensive experience with label printing and we are using old printers on vinyl label stock. So, basically worst case scenario.

It seems like it's up to the company "what good looks like" as far as all printing is legible.

What i'm hoping is to find someone with an example of what dimension of missing print is ok vs. not ok. For instance, any missing print spots must be 3mm or smaller. Something like that.
 

indubioush

Quite Involved in Discussions
#5
It is up to your organization to determine the acceptable label defects based on the associated risk and customer requirements.
 
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