Approval USP Class VI
The approval according to USP Class VI certifies that the product complies with recognized pharmaceutical regulations. These relate to the biocompatibility of plastics. The United States Pharmacopeia (USP) is responsible for approval.
The requirements for the products are graded according to six classes. Class VI is the category with the strictest requirements. Products with USP Class VI approval are therefore suitable for permanent retention in the human body and contact with the bloodstream.
Such requirements apply to implants, for example.
#1 Definition Approval USP Class VI
The approval according to USP Class VI proves that plastic products are suitable for permanent use in the human body with regard to their biocompatibility.
#2 Significance of the USP Class VI approval
Plastics are mainly used in medical devices in the form of seals and tubes. Depending on the specific application, the plastic products must have USP approval for the corresponding class.