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

[ryosaeba]

Could any body clarify me the exact difference between USP class VI versus ISO 10993, Please.

[Marcelo Antunes]

I do not know USP class VI, and know just the necessary of ISO 10993, but reading a little on the net about USP class VI it seems it´s comprised of two specific tests (systemic injection and intracutaneous) made on animals. Well, ISO 10993 is a series of standards which describes a lot of tests (there´s 19 standards in the series and the fisrt is the general one, so it seems to exist at least some 18 different tests, i am not sure of this). The tests to be made depends on some characteristics of the product being tested, for exemple contact time. Also, there´s some tests done on animals, if i remember corrrectly, but most of them are not. Well, that´s what i can think of in a hurry. Cheers.

[Ajit Basrur]

In Reply to Parent Post by ryosaeba

Could any body clarify me the exact difference between USP class VI versus ISO 10993, Please.

Hi, use the search function available at the top or at bottom of the thread and you will come across many threads. One of the most informative for this subject is Biocompatibility - USP Class VI vs. ISO 10933

[ryosaeba]

. That cleared me a bit.

[Ajit Basrur]

In Reply to Parent Post by ryosaeba

. That cleared me a bit.

So do you still have some queries

[g1853]

If a material is found to be USP class 6 compliant and meets the standards of 10993-1, must a med device company repeat those tests, or may they thoroughly document the material is deemed safe?

[MIREGMGR]

USP class qualification was a key method for establishing material biocompatibility at least as far back as 1976, until the 1987 adoption of the Tripartitite Agreement.

Tripartite introduced the first expectations of biocompatibility testing specifically focused on device-related material biocompatibility environments, such as implantation and fluid communication. The relevant guidance memo was G87-1. This is still available on the FDA website.

Under Tripartite, USP class qualification was sometimes accepted as sufficient for lower-risk applications. Tripartite was the FDA biocompatibility approach until 1995.

In 1995, the FDA adopted ISO 10993 as its biocompatibility approach. This is their current stance today. The guidance memo was/is G95-1. USP class qualification no longer plays any role in medical device materials evaluation.

Up-to-date materials manufacturers provide both USP and ISO 10993 test data, to support both pharma and device customers.

See G95-1 for a summary table of the ISO 10993 qualifications required for a given degree of patient contact. A minimum of three qualifications (i.e. test types) is needed for even limited-term unbroken-skin contact.

It is not necessary to repeat material-manufacturer-conducted testing, assuming that the material in fact is identical, the testing is relevant, the documentation is complete and properly prepared, and the testing was done to GLP standards by a registered lab.

[SK Vision]

Is there any centralized respository for material testing results? How would one obtain access to already tested materials?

Like Stainless Steel or TIN Coating.