ISO 10993 - Repeat tests necessary if colour changes slightly?

M

mr.mike

#1
Hi Everyone,

We are wanting to submit samples for Biocompatibility testing (ISO 10993), but the colour is slightly off. I'm curious if there's some way to argue equivalence given that the colouring process is identical, albeit with different proportions of CMYK.

For example, suppose you have a blue rubber ISO 10993 tested, and passed. Then, marketing decides the blue should be slightly lighter. Does this then mean that all the biocompatibility tests have to be repeated? Or can it be argued that the colours and dyes are still the same, just mixed in slightly different proportions?

I realize that what is tested should (ideally) be identical to the final product. But it also seems that design changes involving identical materials, just in slightly different quantities, necessitating a complete re-testing is unreasonably onerous.

Any advice or discussion much appreciated.

MM
 
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M

MIREGMGR

#3
...suppose you have a blue rubber ISO 10993 tested, and passed. Then, marketing decides the blue should be slightly lighter. Does this then mean that all the biocompatibility tests have to be repeated? Or can it be argued that the colours and dyes are still the same, just mixed in slightly different proportions?
FDA regulates color additives because of legacy problems with carcinogenicity and toxicity of substances used for that purpose in the past. The various rules are indexed at http://www.fda.gov/forindustry/coloradditives/default.htm.

If an additive by itself has been formally shown to be safe (i.e. "GRAS") up to a specified concentration and you use it at a concentration that does not exceed that specification, the specific quantity of additive used in a particular polymer batch should not be relevant.

If an additive by itself has not been formally shown to be safe but you have shown it to be safe in a particular concentration as blended into a polymer batch, you can infer from that testing that it also will be safe at a lower concentration.
 

NikkiQSM

Quite Involved in Discussions
#4
Hi Everyone,

We are wanting to submit samples for Biocompatibility testing (ISO 10993), but the colour is slightly off. I'm curious if there's some way to argue equivalence given that the colouring process is identical, albeit with different proportions of CMYK.

For example, suppose you have a blue rubber ISO 10993 tested, and passed. Then, marketing decides the blue should be slightly lighter. Does this then mean that all the biocompatibility tests have to be repeated? Or can it be argued that the colours and dyes are still the same, just mixed in slightly different proportions?

I realize that what is tested should (ideally) be identical to the final product. But it also seems that design changes involving identical materials, just in slightly different quantities, necessitating a complete re-testing is unreasonably onerous.

Any advice or discussion much appreciated.

MM

If you were to change the colorant used - then BioComp testing would of course be required again.

If you are going to change the amount of colorant used - as long as it is not a drastic difference in the original amount - you should be fine with not conducting the testing again.
 
M

MIREGMGR

#5
If you are going to change the amount of colorant used - as long as it is not a drastic difference in the original amount - you should be fine with not conducting the testing again.
My understanding is:

True if the amount of colorant is decreased.
Not true if the amount of colorant is increased.

This of course assumes that the colorant is not GRAS. If it is, the problem goes away.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
If you are unsure, you can ask a 3rd party biocomp. test lab (e.g. NAMSA, no affiliation) expert-toxicologist to review your specifics and issue a formal written opinion. Might come handy later, if questions are asked during inspection.

If the change is not big, most chances it will end with a remote desktop review and no testing.
 
M

mr.mike

#8
Yes, I did inquire to 3rd party test labs. In my experience, regardless of the question, they are always pretty vague. The standard answer is something along the lines of "it should be the same as the final product. If not, you will have to justify why it's not."

Fair enough. I'm sure they're just covering themselves, as it's not their responsibility to be giving definitive regulatory advice.

As it is, I'll take a look at the FDA approved list of colourants for medical devices (and cross my fingers the ones used are on it). Barring that, luck would have it that the samples we submitted have higher amounts of all CMYK than the final colour, so we can always justify as suggested by MIREGMGR.

Thanks everyone!
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Did you ask for the casual "free advice" or did you offer to pay for a proper review and a written expert opinion? One usually gets what they pay for.
 
A

AJayC

#10
Color Additives For Medical Devices

If you use a "direct food contact ink" for printing on a medical device, for the 510K submission are we required to list the color additive in the ink?

The device's intended use will mean the printed area of the device will touch human skin for a short period (<24hrs). Therefore, Biocompatability testing will be performed on the finished product.
 
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