Hi matess,

Encounter an issue regarding the bicompatibility testing for face mask.

We have contacted a few laboratory for conducting biocompatibility testing for face mask, found out that some lab said the testing will carried out on a rabbit, some said human and some even said pig. (of course the cost will different here!)

So, which is the one should we go for? Can any expert here explain and may know anywhere of the standard stated which is the animal should be choose for this type of testing?

Tiff :bonk:

I doubt the facemask will fit properly on the rabbit. As far as the pig or the human, I often see no difference between the two! Frankly, I believe testing on animals is cruel and disgusting. Unfortunately, I've never seen an ISO document that supports the ethical treatment of animals.

I doubt the facemask will fit properly on the rabbit. As far as the pig or the human, I often see no difference between the two! Frankly, I believe testing on animals is cruel and disgusting. Unfortunately, I've never seen an ISO document that supports the ethical treatment of animals.

Please, let's not get into the subject of the ethics of using animals for testing purposes and stick to the topic of the appropriate test methods.

Hi matess,

Encounter an issue regarding the bicompatibility testing for face mask.

We have contacted a few laboratory for conducting biocompatibility testing for face mask, found out that some lab said the testing will carried out on a rabbit, some said human and some even said pig. (of course the cost will different here!)

So, which is the one should we go for? Can any expert here explain and may know anywhere of the standard stated which is the animal should be choose for this type of testing?

Tiff :bonk:

I would suggest looking at ASTM standards You might have some luck there with testing standards.

I doubt the facemask will fit properly on the rabbit. As far as the pig or the human, I often see no difference between the two! Frankly, I believe testing on animals is cruel and disgusting. Unfortunately, I've never seen an ISO document that supports the ethical treatment of animals.

ISO 10993-2:2006 Biological evaluation of medical devices
Part 2: Animal welfare requirements


Whilst I understand both Jeffrey and Jim's positions, the use of animals in biocompatability testing is the current clinically-established, and politically-supported requirement. I appreciate that Jeffrey might reasonably argue that any testing on animals is unethical, but to suggest there is no ISO requirement for appropriate welfare of the involved animals is simply wrong.

As for the testing itself, a lot depends on the tests required to be done, see ISO10993-1 for guidance. Depending on the material being used, and your processing of it (i.e. do you add nasty chemicals to the surface of an otherwise-benign plastic material), you may be able to avoid such testing altogether, via a suitable literature review.
That would keep everyone happy!

If your situation does require laboratory testing, the tests require generally dictate the types of animals required. I would liaise with your likely test house as to what animals would be suitable for which tests. Human subjects may be appropriate, but I would suggest that is unlikely, they are typically reserved for final stage clinical investigations of pharmaceuticals and complex/high-risk devices. (Which, by the way, are not risk-free (http://news.bbc.co.uk/2/hi/uk_news/england/london/4807042.stm)).

Hi matess,

Encounter an issue regarding the bicompatibility testing for face mask.

We have contacted a few laboratory for conducting biocompatibility testing for face mask, found out that some lab said the testing will carried out on a rabbit, some said human and some even said pig. (of course the cost will different here!)

So, which is the one should we go for? Can any expert here explain and may know anywhere of the standard stated which is the animal should be choose for this type of testing?

Tiff :bonk:
I would go back to first principles. What is (are) the face mask material(s)? Are they a medical grade polymer? The polymer supplier should be able to supply compliance details. Therefore no animals need be involved. Biocompatibility (via pharmacopoeia requirements e.g. USP) tends to be a requirement for say liquid drugs in their (polymer) packaging or implants etc.

Hi,

did you figure out yet which biocompatibility system is the most appropriate for your application?
Here are my two cents: you can request a copy of 510K approval for a predicate device (analogous to Crosstex surgical mask for example) and follow the test methods described which you can reference further. Without knowing the specific properties of your material I am just reciting ISO 10993- part 10( skin irriatation study) where delayed-type 24 h hypersensitivity study could be done on rabbits and closed patch sensitization study (short term but repeated exposure) on quinea pigs.

Hope this helps
BuzyBee

Hi,

you can request a copy of 510K approval for a predicate device (analogous to Crosstex surgical mask for example) and follow the test methods described which you can reference further.:2cents:Yes you can request a copy of a 510(k) (http://www.devicelink.com/mddi/archive/07/02/019.html), but who has 2 years to wait until you get it.

We have been lucky: the latest requested file was delivered within 2 weeks! Maybe by mistake our request was put on the top of the pile :D!

BusyBee

We have been lucky: the latest requested file was delivered within 2 weeks! Maybe by mistake our request was put on the top of the pile :D!

BusyBeeDid you use a service that already had it (http://www.foiservices.com/index.cfm)? Whenever a request comes in to FDA, they notify the 510k owner so that they can redact proprietary information.

We got file through FDA; excluded proprietary information was related to the mechanism of action and/or design but not the clinical considerations or safety test studies which one could successfully argue are relevant to the public safety under Freedom of Information Act.
In any case, there is a plenty of information available on-line, such as white copies of test reports (file attached) where test procedures are outlined.

BusyBee