What is USP Class VI requirements?

USP Class VI refers to a set of biocompatibility testing requirements from the U.S. Pharmacopeia (USP), a non-profit organization whose standards inform decision-making at the U.S. Food and Drug Administration (FDA).

What is USP 88 Class VI?

What is USP CLASS VI? USP 88 is designed to determine biological response of animals to elastomerics, plastics, and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test.


Primarily biopharmaceutical manufacturers use USP Class VI for their process equipment. Sterile and diaphragm valves have USP Class VI PTFE material in them, and sanitary pumps require Class VI O-Rings and sealing material.

What is VI certified?

Being a VI-Certified product means that a testing schema, approved and reviewed by VI-grade, has been completed and is regularly validated on all VI-grade simulators. Participating partners also commit to providing timely software updates within each new version as well as dedicated customer support.

What is systemic injection test?

Systemic injection testing is designed to determine the systemic biological responses of animals to plastics (or other polymers) by a single-dose injection of sample extracts from medical devices or therapeutic products. Systemic injection testing and intracutaneous testing may be performed using the same extracts.

Is PFA USP Class VI?

FEP and PFA meet USP Class VI Criteria Chemfluor® FEP and PFA tubing fully complies with the requirements of USP Class VI Criteria and are non-toxic, non-hemolytic and non-pyrogenic.

Is polypropylene USP Class VI?

Due to increased customer demand and a change in supplier certifications, Value Plastics, manufacturer of plastic tube fittings, has chosen to include a certified USP Class VI polypropylene as one of their core resin offerings.

What is a Class VI plastic?

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.

Is ETFE biocompatible?

Fluoropolymers and Biocompatibility Fluoropolymers that are Class VI USP approved include PTFE, ETFE, FEP, PFA and PVDF (to name just a handful).

What are the USP classes?

The USP defines six plastics classes, from class I to class VI with class VI being the most rigorous and most frequently requested certification. Many plastics manufacturers find it advantageous to have their materials classified, especially if their plastic resins are a likely candidate to be used in medical devices.

What is CF ETFE?

Ethylene tetrafluoroethylene (ETFE) is essentially an alternating copolymer consisting of ethylene and tetrafluoroethylene segments. This a tough material with high impact resistance and useful mechanical properties up to near 350 degrees F (177 degrees C).

What does USP Class VI Mean?

USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. There are six classes, VI being the most rigorous. Class VI testing is aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials.

What is USP Class VI plastic?

USP Class VI refers to one of the six designations for plastics from General Chapter <88> of the United States Pharmacopeia and National Formulary (USP-NF). This chapter provides guidelines for testing and certification of a material to be used within a medical device. USP Classification of Plastics (USP <88> Biological Reactivity Tests, In Vivo)

What is an USP standard?

Definition of USP standards. USP standards means the pharmacopeial standards for drug substances, dosage forms, and compounded preparations based on designated levels of risk as published in the official compendium. USP standards or “USP” means the Reference Standards published by the United States Pharmacopeia Convention Inc.