A process validation protocol to demonstrate the safety and functionality of polyvinylchloride & polyethylene (PE/PVC) co-extruded tubing used to replace PVC-only tubing in medical-device column and precolumn assemblies. Acceptance criteria includes cytotoxicity, tubing cutter evaluation, permeability testing, extrable DEHP, solenoid volve compatibility, tensile test, barb connection, and RF sealability. Attached forms include Preparation of Test Samples, Tubing Sample - Accelerated Aging Record, Cytotoxicity, Permeability Test, Extractables Evaluation, Tensile Test, Solenoid Valve Compatability, RF Sealability & Barb Connection Test. Adheres to ISO 3826, "Determination of exractable di-(2-ethylhexyl)phthalate (DEHP)." The PV Report is available as 04-0080-PVR-1.0.
| Edition : | 1 |
| File Size : | 1
file
, 170 KB |
| Number of Pages : | 17 |
| Published : | 10/01/2004 |
