In the United States, USP is a non-profit organization that relies on experts from around the world to set manufacturing standards for medical devices and related areas such as dietary supplements, food ingredients, pharmaceuticals and health products. The USP Level 6 medical device test is the most rigorous test of plastic materials for medical use and pipe products for biopharmaceutical applications, and is a non-clinical laboratory study that conforms to various experimental specifications.

USP class VI certification

The United States Pharmacopeia (USP) is a non-governmental organization that supports public health by developing up-to-date standards to guarantee the quality of medicines and other medical industry technologies. The organization focuses on the pharmaceutical and biotechnology industries. USP sets standards for the quality, purity, strength, and consistency of pharmaceutical grade related products. These USP standards are published in the United States Pharmacopeia and National Formulary (USP NF) USP Category V for a range of biological tests. USP Class VI compounds must be made from ingredients with a clear history of biocompatibility to meet the stringent sanitary grade requirements for the pharmaceutical industry.

Plastics tested for in vivo biological response will be classified as designated medical grade plastics in accordance with the USP-NF general rules. The purpose of the test is to determine the biocompatibility of the plastic and its suitability for use in medical devices, implants, and other systems. There are six levels of plastic grading test in the United States USP Class USP Class VI. A plastic that has been rated as Grade 6 in the United States for medical plastics means that * comprehensive and rigorous testing has been established. American Medical Materials Grade VI is now the gold standard for all types of medical-grade raw materials and is a very good choice for medical device manufacturers.

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