USP Class VI vs. ISO 10993 - What are the differences?

[MegSinha]

Re: USP class VI versus ISO 10993

thread - 1615, already mentioned once in this discussion

With respect to both the threads I had a question and was hoping someone could help me out!

We have a USP Class VI canister which is e-beam sterilized, I was wondering if we need to still do bio-compatibility testing on a sterilized product

Thanks a lot in advance!

 

[MIREGMGR]

Re: USP class VI versus ISO 10993

Is the canister a medical device, and the product? (As opposed to a pharma packaging system, for instance.)

If yes to the first question, then USP Class VI is not a relevant qualification for it. You might establish biocompatibility via making the device of a Recognized Consensus Standard material using a validated process that does not degrade that material, or by ISO 10993 testing.

Depending on the device's use, the sterilization process might obligate you to do ISO 10993 testing because of the possibility of chemical degradation that could affect biocompatibility.

 

[MIREGMGR]

Re: USP class VI versus ISO 10993

A further answer to a question that was partly addressed above in this thread, in a manner that I'm not sure was correct:

My understanding is that a statement in a 510(k) that a material is USP Class VI in general will not be accepted by FDA as equivalent to evidence establishing that the nominally corresponding ISO 10993 qualification is satisfied, because the testing protocols are not identical and the test lab from which the results originally came, presumably originally certified only to the Class VI outcome.

My understanding is that the FDA ceased accepting Class VI testing as equivalent to the corresponding ISO 10993 testing as of 1987.

 

[MegSinha]

Re: USP class VI versus ISO 10993

It is a medical device, it is used as a collection canister during liposuction procedures, the material that we use is polystyrene and then do radiation sterilization. I understand what you mean by degrading the material. But, in case the vendor of the material says that it does not degrade even with e-beam sterilization can we use that rationale to say we don't need bio-compatibility?

Thanks for your reply!

 

[MIREGMGR]

Re: USP class VI versus ISO 10993

the vendor of the material says that it does not degrade even with e-beam sterilization

Is the evidence that they have provided you...say, a detailed theoretical chemical analysis of worst case irradiation effects corroborated by assay analysis, or ISO 10993 testing of worst case irradiated samples...sufficient to convince the FDA?

(By the way, I keep referencing "US FDA" even though this is in an ISO forum-section. USP Class VI has never had legal substance under European rules, as opposed to US rules where it was meaningful until 24 years ago, so my assumption is that the questions pertain to an FDA context. If that's incorrect, I apologize.)

 

[MegSinha]

Re: USP class VI versus ISO 10993

No it's with respect to the FDA, no they haven't provided us any such documents. But they just say this on their site. You think we might still need to do the testing?

Also, when I read ISO 10993 - I cannot really classify the device in the sense that it is used to collect the fat that is used for re-injection in the patient, but it is still a no contact device because the cannula is the one really contacting the body. So, can we slip through and say its a non contacting device and does not need bio compatibility testing?

 

[MIREGMGR]

Re: USP class VI versus ISO 10993

No it's with respect to the FDA, no they haven't provided us any such documents. But they just say this on their site. You think we might still need to do the testing?

Only objective evidence counts. You could call them and ask if they'll provide some FDA-acceptable objective evidence of their statement. Be sure to tell them, though, that you need a signed certification from them as to the provenance of the evidence, and that that signed certification may be reviewe by the FDA.

Also, when I read ISO 10993 - I cannot really classify the device in the sense that it is used to collect the fat that is used for re-injection in the patient, but it is still a no contact device because the cannula is the one really contacting the body. So, can we slip through and say its a non contacting device and does not need bio compatibility testing?

You need to review US FDA guidance G95-1, and in particular Attachment A. It sounds to me as if your device is an external communicating device, blood path, indirect...or maybe tissue path, communicating, but I doubt it if the removed fat contains any blood, which I think would be common.

 

[MegSinha]

Re: USP class VI versus ISO 10993

I do agree with you, but we are trying to get information from the vendor to see what bio compatibility testing have they done. It's kind of hard to convince my boss if I don't have all the information to tell him that we absolutely need to do this.

Thanks so much for all your help!

 

[cisko]

Re: USP class VI versus ISO 10993

With regard to FDA regulation, the most common materials--particularly metals--are defined per Recognized Consensus Standards.

Thus if a metal material is certified by the maker, or by a distributor if cert traceability exists up to the maker, as being compositionally consistent with an applicable standard, that material is regarded as biocompatible as defined in the applicable Recognized Consensus Standard.

Hi!

Can you show me where did you find this info on FDA regulation ? Which part ? Do you have the url of that ?

Thanks!

 

[Ajit Basrur]

Re: USP class VI versus ISO 10993

Hi!

Can you show me where did you find this info on FDA regulation ? Which part ? Do you have the url of that ?

Thanks!

Its here - (broken link removed)