USP
The United States Pharmacopoeia and the National Formulary are the official compendia of standards for drug, excipients dietary supplements, and other therapeutic products for the United States and several other countries. It is an independent organization under one cover. The USP contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for more than 3400 drug substances, preparations and products. When a standard is published in the USP-NF, federal and state government agencies, such as FDA have the authority to enforce them and to ensure that products comply.
Most important test protocols for elastomer and perfluorocarbon products (seals) are:
USP Class VI testing Part 88, Biological reactivity test Part 87, in vivo. It is designed to determine the biological response of animals to elastomeric, plastic and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the article under test.
USP testing Part 87, Cytotoxicity test, Biological reactivity test, in vitro. It is designed to determine the biological reactivity of mammalian cell cultures following contact with the elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the article under test.
USP testing Part 661, is a Physicochemical Test which determines the Physicochemical properties of certain material. This test measures defined properties of impurities in plastics. The material is for example PTFE or TFM.
USP testing Part 381, is a Physicochemical Test which determines the Physicochemical properties of certain material and impurities extracted from elastomeric closures. The material is for example EPDM and FKM. Not Silicone.