USP Class VI - "Medical Grade" Materials

USP Class VI (Or USP Class 6) is a set of guidelines established by the United States Pharmacopeia (USP) to ensure that materials used in medical devices and pharmaceuticals are safe and suitable for use in humans. In this blog, we will explore what USP Class VI is, why it is important, and what it means for materials used in medical devices.

What is USP Class VI?

USP Class VI is a set of guidelines that define the testing requirements and standards for materials used in medical devices and pharmaceuticals. The USP Class VI guidelines were established to ensure that these materials are safe and suitable for use in humans. To meet USP Class VI requirements, materials must pass a series of tests that evaluate their biocompatibility, toxicity, and other important properties.

Why is USP Class VI important?

USP Class VI is important for several reasons. First, it ensures that materials used in medical devices and pharmaceuticals are safe for human use. This is especially important because these materials come into direct contact with the human body and can have serious health consequences if they are toxic or cause an adverse reaction.

Second, USP Class VI guidelines provide a consistent and standardized approach to evaluating the biocompatibility of materials used in medical devices and pharmaceuticals. This ensures that all materials are tested using the same rigorous criteria, which helps to ensure their safety and effectiveness.

Finally, compliance with USP Class VI guidelines is often a requirement for regulatory approval of medical devices and pharmaceuticals. This means that materials that do not meet USP Class VI requirements may not be approved for use, which can delay the approval process and increase costs.

What does USP Class VI mean for materials used in medical devices?

For materials used in medical devices, compliance with USP Class VI guidelines is essential. Materials that are intended for use in medical devices must be tested and certified as USP Class VI compliant before they can be used in medical devices. This certification ensures that the material is safe and suitable for use in humans.

USP Class VI materials are a classification of materials that meet certain criteria for biocompatibility, as defined by the United States Pharmacopeia (USP). These criteria include the ability of the material to cause minimal tissue irritation, minimal systemic toxicity, and no carcinogenic, teratogenic, or mutagenic effects.

The USP Class VI designation is based on a series of tests that are performed on the material, including tests for cytotoxicity, sensitization, and implantation. If a material passes these tests, it is considered to be biocompatible and safe for use in medical devices. The tests are generally described by two certification groups: USP Class VI 87 and USP Class VI 88.

The USP Class VI 87 and USP Class VI 88 tests are similar in many ways, as they both evaluate the biocompatibility of materials using a series of tests for cytotoxicity, sensitization, and implantation. However, there are some key differences between the two versions of the tests.

One significant difference between USP Class VI 87 and USP Class VI 88 is that the latter version includes additional tests for genotoxicity and pyrogenicity. Genotoxicity testing evaluates the potential for a material to cause mutations in DNA, while pyrogenicity testing evaluates the potential for a material to cause fever. These additional tests help to provide a more comprehensive assessment of the safety and biocompatibility of a material.

Another difference between the two versions of the tests is that USP Class VI 88 places greater emphasis on the characterization of the material. This includes evaluating the purity, chemical composition, and physical properties of the material. This emphasis on material characterization is intended to ensure that the material is consistent and of high quality.

Some common examples of USP Class VI materials include silicones, certain types of plastics, and certain types of metals. These materials are often used in the manufacture of medical devices such as catheters, implantable devices, and surgical instruments. They can typically be manufactured in virtually any geometry, such as O-rings, gaskets, custom rubber parts, and custom plastic parts.

In addition, manufacturers of medical devices must be able to demonstrate that the materials they use in their devices are USP Class VI compliant. This means that they must be able to provide documentation and test results that prove the material has been tested and certified as compliant.

Conclusion

USP Class VI is a set of guidelines that define the testing requirements and standards for materials used in medical devices and pharmaceuticals. Compliance with these guidelines is essential to ensure the safety and effectiveness of medical devices and pharmaceuticals. If you are developing medical devices or pharmaceuticals, it is important to ensure that the materials you use are USP Class VI compliant and that you can provide the necessary documentation to prove compliance.

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Sources:

[1] Foster Corporation. (2021, April 23). USP Class VI - foster Corporation. https://www.fostercomp.com/stewardship/usp-class-vi/

[2] USP Class VI Standard | Anderson-Negele North America. (n.d.). Anderson-Negele North America. https://www.anderson-negele.com/us/knowledge-center/technologies/usp-class-vi-standard/