Approved for Medical Device Labeling - Medical Requirements for Printer

RCW

Quite Involved in Discussions
#1
Looking for some guidance here.....

I have run across requirements that labeling be printed on medical-grade or approved-for-medical-device labels BUT is there a requirement that the printer has to also be qualified for printing medical device labels? Or is this possibly just a customer flowdown?

Any help here?
 
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R

Roland Cooke

#2
Re: Labeling - Medical requirements for printer

I've not heard of any specific requirements in relation to this, although such may exist for specialist products. So it's likely a customer-specified requirement.

But at the end of the day, any manufacturing equipment - including a label printer, of course - has to be shown to be able to perform the task effectively and consistently, perhaps via a validation.
 

RCW

Quite Involved in Discussions
#3
Re: Labeling - Medical requirements for printer

But at the end of the day, any manufacturing equipment - including a label printer, of course - has to be shown to be able to perform the task effectively and consistently, perhaps via a validation.
That's where I was thinking this "requirement" came from. I can see validating the printing process through the use of the printer but I can't see there being a medical-industry standard on printers.
 

yodon

Staff member
Super Moderator
#4
Re: Labeling - Medical requirements for printer

You may also need to - for lack of a better term - validate the printed label; e.g., durability - especially if there is any exposure to solvents. This would show the printed material retains all readability properties.
 
W

world quality

#5
I was reading all the replys and I can give you the requirements for Automotive , B series doc's that tells how and why and what has to be readable and with 3D if needed.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#10
Gert - B-10 Label Guidelines.pdf

I am in the process of evaluating the server capacity and increasing the file size limit on uploads. Gert sent me this which is technically too big to upload as an attachment. I have to get a server expert to evaluate the server and the 'significant' settings (php, mysql, etc.) to see why files larger than 2 megabytes can't be uploaded.

In the meantime, here is Gert's file: B-10 Label Guidelines.pdf. :agree1:
 
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