usp class vi pdf

When the surface area of the the class designation of a plastic must be accompanied by specimen cannot be determined use 01 g of elastomer oran indication of the temperature of. Interim Revision Announcement 2 87 Biological Reactivity Tests In Vitro Official November 1 2015 NaCl or serum-free mammalian cell culture media as Ex-Table 1.

Ssp 2390 Series Specialty Silicone Products Inc

Time tested for USP Class VI compliance This article was manufactured using procedures typically required to produce final parts.

. The sample is designated as E553 Article within our. EPDM red Silicone and VitonTM. USP Class IV USP Class V USP Class VI USP Class IV USP Class VI USP Class VI USP Class IV USP Class VI USP Class VI.

Moldable polyurethanes Resilon 4300 and 4301 Molythane 4615 Machinable polymer-filled 0618 PTFE Life Sciences Capabilites. Moulded O-rings class 1 less than 10 furnace black These can be produced in all. FDA and USP Class VI O-ring materials for life sciences Parker Compound Polymer Hardness Color Temperature Range F Service EJ280-70 EPDM 70 Black -70 to 250 FDA USP VI.

L929 MEM Elution Test USP S60121 Article meets the requirements of the test and is not considered to have a cytotoxic effect. Our USP Class VI certified material offering includes. USP Class VI testing is conducted by producing an extract of the product with different extraction fluids such as polyethylene glycol and vegetable oil and injecting it in specimen rabbits and.

High quality USP Class VI compliant sheet material made from our own specially formulated compounds. USP Class VI ISO 10993-5 Cytotoxicity In-Vitro ISO 10993-3 Ames Genotoxicity ISO 10993-11 Systemic Toxicity In-Vivo ISO 10993-4 Hemolysis Indirect European Pharmacopeia 329. Biological Test for Plastics USP Class VI 121oC S60121.

Consumers implicitly rely upon the standards put into place by governing agencies to protect the publics health and well-being. Sil 714001 USP class VI Silicone 1 70 Yes transl. Sil 714002 USP class VI Silicone 1 70 Yes transl.

Sheet material is available in various thick. USP Class VI compliant O-Rings N ewmans USP Class VI compliant Platinum Cured Silicone O-Rings are complimented with our Class VI EPDM black or whiteperoxide cured and Viton. Both ISO 10993 and USP Class VI define testing requirements for biocompatibility the ability of a material to perform a desired function without causing adverse effects on the.

When evaluating a new product many of our.

Keofitt World Leaders In Sterile Sampling