The United States Pharmacopoeia (USP) 30, NF 25, 2007 standard, also known as Class VI, is widely used to comply with stringent FDA regulations for products that come in contact with the human body. The USP outlines classes for plastic materials, i.e. I - VI, with USP Class VI being the strictest, requiring that the material exhibit very low levels of toxicity proven through a series of tests. These USP Standards are set for quality, purity, strength and consistency and published in the US Pharmacopeia and the National Formulary (USP NF).

To achieve USP Class VI certification, the material goes through a series of biological tests:

(1) Systemic toxicity,

(2) Intracutaneous reactivity, and

(3) Muscle implantation.

Each testing category includes a full range of tests, procedures and industry best practices for all phases of pharmaceutical and medical device development and manufacturing.

A plastic material that has passed class VI certification is expected to be more likely to produce favorable biocompatibility results in order to eliminate the risk of adverse reactions in patients

To achieve USP Class VI certification, the material goes through a series of biological tests:

(1) Systemic toxicity,

(2) Intracutaneous reactivity, and

(3) Muscle implantation.

Each testing category includes a full range of tests, procedures and industry best practices for all phases of pharmaceutical and medical device development and manufacturing.

A plastic material that has passed class VI certification is expected to be more likely to produce favorable biocompatibility results in order to eliminate the risk of adverse reactions in patients