USP Class VI.

Designed primarily as a means of evaluating plastics used in drug packaging, “USP Class VI” refers to a battery of biological tests defined in USP XXIII, part 88. Any food-grade material–which means most silicones–that has passed this test series can be designated USP Class VI. The series is a four-part evaluation involving animal (mouse and rabbit) testing of extracts of saline, vegetable oil, alcohol, and polyethylene glycol 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 significance of the results and their level of safety assurance for medical devices are limited. For example, it would be possible for a material to pass USP Class VI while still showing up as cytotoxic, mutagenic, hemolytic, or sensitizing in other biological testing.

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