What does USP Class VI mean?
USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. 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 a USP class?
USP Class tests are assays designed to determine the biological response of animals to direct and/or indirect contact with a test article.
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 class 7 in the Army?
Class VII – Major end items such as launchers, tanks, mobile machine shops, some parachute systems and vehicles. Class VIII – Medical material (equipment and consumables) including repair parts particular to medical equipment.
What do you need to know about USP Class VI seals?
Testing for compliance involves an assessment of the effects of the material, and extractables, on tissue. Three chapters are applicable to elastomers, plastics and polymeric materials. Chapter 87 (biological reactivity in vitro testing): EPDM, Silicone, FKM, FFKM ( Perlast ® seals for life sciences)
What is the purpose of the USP 87 test?
USP 87 is designed to determine the biological reactivity of mammalian cell cultures following contact with elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the materials under test. Mammalian fibroblast, L-929, cells are utilized for cell culture in USP.
Which is the most stringent USP Class for plastics?
USP Classification of Plastics (USP <88> Biological Reactivity Tests, In Vivo) The USP Class VI designation is considered the most stringent and, therefore, most useful for medical applications. It involves the following three in vivo biological reactivity evaluations, generally performed on mice or rabbits to mimic use in humans:
Which is an example of an USP class test?
USP <88> In-Vivo Biological Reactivity – Class I–VI Testing USP Class tests are assays designed to determine the biological response of animals to direct and/or indirect contact with a test article.
