NOTE: I originally posted this in a couple ASQ Discussion Groups and have had no takers in the past week. I don't know if this is the appropriate discussion group, but folks dealing w/ ISO 13485 seemed a logical place to start!

Is anyone well versed or familiar with the differences between USP Class VI material certification vs. ISO 10933?

We are currently using an epoxy for which the manufacturer supplied a "C of C" to USP Class VI. I've found an article on the Web by a Mr. Alastair Winn which states in part;

"...2. "USP Class 6" is a battery of biological tests defined in USP XXII, Part 88, which was primarily designed for evaluating plastics used in packaging drugs. Any "Food Grade" material, which means most silicones, which will pass this test series can be called " USP Class 6". It is a four part evaluation involving animal (rat and rabbit) testing extracts of saline, cottonseed oil and alcohol along with a 5 day rabbit intramuscular implantation test. While this level of testing is widely used and accepted in the medical products business, the meaning of the results and the level of safety assurance for medical devices is limited. For instance, it would be possible to pass USP Class 6 while still showing up as cytotoxic, mutagenic, hemolytic or sensitizing in other biological testing."

I guess this is what concerns me. I see a lot of claims for materials tested to USP Class VI -- for a medical devise, should we also be concerned with "Cytotoxicity" and/or "Hemolytic" or "Sensitization" testing? If you look at the ISO 10933 matrix, we are most often in the "A" (limited <24hr) or "B" (prolonged 24hr<X<30 Days) category of of exposure.

Any guidance someone can provide would be greatly appreciated. It appears this is a "new topic" as I cannot find any references in the cove.

Thanks in advance for any help anyone can provide.

-Steve

Look at the thread, Testing compliant to USP Class VI and ISO10993-1 compliant. Is that possible? (http://elsmar.com/Forums/showthread.php?t=12364)

I believe that ISO 10993 is considered the standard to meet, but if you are making a submission, you might want to discuss the requirements with FDA. Another route might be to discuss it with someone at one of the testing labs. There is some information in this old article. (http://www.devicelink.com/mpb/archive/97/05/001.html)

Al: THANK YOU!! Finally, someone has responded to my plea for help:D

I had found the old thread you mentioned and had read through it, but thanks for pointing it out! The "old" article you mentioned (and old it was, but still useful) had a cross-reference between the two methods I was looking for. In the "Sidebar" of that article it stated:

"RELATION TO U.S. PHARMACOPEIA

To test medical device biocompatibility, manufacturers often use USP procedures such as the USP in vivo biological reactivity tests (Class I–VI plastics tests).

While class plastics tests have some value in a biocompatibility testing program, a full Class VI test is rarely needed for a medical device. As a general rule, the Blue Book memo and ISO documents take a broader and more thorough view of biocompatibility than does the U.S. Pharmacopeia, and they supersede the USP for evaluating which studies to submit to FDA in support of product registrations."

This excerpt adds a little more specificity to the cloud of doubt I had. What's still a little confusing is the last statement in this excerpt. Our potential vendor supplied the testing for Class VI which included "Acute Systemic Toxicity (USP)", "Intracutaneous Toxicity (USP)" and "Implantation Test (USP)". This sounds like they've covered the bases for ISO 10933 for "Limited Exposure", but I think your advise of "...discussing it with someone at the test labs." is probably the best advise of all. If anyone should know, they should --- at least one would think!

Thanks again Al!!:)

-Steve

:topic: I must say, even though there is some "cross pollenation" between ASQ and the Cove, the Covers are definitely more helpful - at least so far!

Thanks again --- just felt I need to say this! -Steve

Noticed I misspelled my praise! OOPS!

:topic: I must say, even though there is some "cross pollenation" between ASQ and the Cove, the Covers are definitely more helpful - at least so far!

Thanks again --- just felt I need to day this! -SteveThanks for recognizing that Steve.

Hi

This is a subject that has been close to my heart recently. The following reference discusses the issue with a European perspective, but you may find the general principles it expounds to be thought provoking.

'Biological Safety & European Medical Device Regulations' JJB Tinkler, Quality First International Ltd ISBN 1903757002

I have no financial interest in this publication.

Mike Caudwell

Mike (and Al):

Based on Al's initial advise to my original post, I decided to go directly to the the testing house we typically use for Biocompatibility Testing (we use NAmSA). The gentleman I spoke with over there gave me the definitive answer I was looking for (good advice Al!). For anyone searching for the same answer and running across this thread, I thougth I'd summarize that response below.

USP Class VI typically requires the following tests;
1) Acute Systemic Toxicity
2) Intracutaneous Tocixity
3) Implantation Test

If one is required to adhere to ISO 10933, then the only overlap between the two test methods/regimens is the Intracutaneous Toxicity test (for an ISO Class A, skin contact device). One must still perform, at a miminum, Cytoxicity and Sensitization per the ISO 10933 protocol. So for our "Class A Surface Devices", the only two additional tests we would need to perform to meet ISO 10933 are the Cytoxicity and Sentization, per NAmSA, for this particular material. Other device classes would probably require more testing, but since they are not what we manufacture I didn't ask this question.

I hope this is helpful...

Thanks for the update Steve.