What is USP Class VI requirements?

USP Class VI materials meet the most stringent requirements and include silicones that pass a systemic toxicity test, an intracutaneous test, and an implantation test. Yet some suppliers that use compliant ingredients may still not be able to guarantee a compliant end-product.

What is a USP Class VI material?

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 88 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.

What are Class VI elastomers?

Liveo™ Class VI Elastomers (C6-series) are uncatalyzed silicone elastomer bases designed for compounding into elastomer for part fabrication and medical devices, including those intended for implantation in humans for up to 29 days.

What is the difference between USP Class VI and ISO 10993?

USP Class VI Testing is only one standard of biocompatibility, however. Though not a limited series of tests, some biocompatibility requirements for medical devices may exceed the testing performed in USP Class VI. A more rigorous standard for the biological evaluation of medical devices is ISO-10993.

Is PTFE USP Class VI?

Sterile and diaphragm valves have USP Class VI PTFE material in them, and sanitary pumps require Class VI O-Rings and sealing material. AFT Fluorotec can manufacture a wide range of components using our USP Class VI PTFE compliant material and are supplying customers worldwide to meet their requirements.

Is polypropylene USP Class VI?

Medical Grade Polypropylene Our USP class VI polypropylene is 100% virgin medical, lab and food grade and is even autoclave sterilizable. This material is also BPA, Lead and heavy metal free, phthalates safe and is REACH, RoHS, DMF and FDA compliant.

What are USP classes?

A USP Category is the broadest classification of the USP Drug Classification system and provides a high level formulary structure. In USP DC 2022 there are 51 USP categories. A USP Class is a more granular classification, occurring within a specific USP Category in the USP Drug Classification system.

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.

What is the difference between USP Class VI and ISO 10993 biocompatibility requirements?

What is a Class 6 O ring?

These o-rings are manufactured from some of the world’s finest silicone rubber. They are molded to exacting standards. Many common sizes are in stock for immediate delivery. These are sizes that we currently have the tooling to produce.