ASTM F2102-17 pdf free download.Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants.
ASTM F2102-17 covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (>C=O) centered near 1720 cm^-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide.
ASTM F2102-17 covers method for evaluating the relative extent of oxidation in ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants.
8. Precision and Bias
8. 1 Precision-The data in Tabl based on a series of international interlaboratory studies using this method which were conducted in 1999 and 2000, in accordance with Practice E691, involving up to twelve institutions across the United States and Europe. Metrics of repeatability and reproducibilit between different institutions were calculated as outlined in Practice E691 and normalized with respect to the mean oxidation index to estimate relative uncertainty. The data for the GUR 4150 HP rod stock were collected on as-irradiated microtomed samples. For the long-term shelf-aged tibial implants, the data were collected below the surface at the location of maximum oxidation. All samples were 200-um- thick microtomed films gamma irradiated in air.
7. Report
7. I The report shall contain at least the following experi mental details and results
7.1.1 Material Information
7. I.I. I Resin type and resin lot number
7.1.1.2 Consolidation method and manufacturer and manu- facturer lot number
7.1.1.3 Any special post-consolidation treatments, for example, shot isostatic pressin HIPing),annealing sterilization, cross-linking, stabilization, accelerated aging, and storage conditions.
7.1.2 Sample Information:
7. 1. 2.1 Orthopedic implant or laboratory test specimen
7. 1. 2. 2 Time elapsed between sample preparation and test ing in the FTIR
9. Keywords
9.1 FTIR,implant,oxidation,oxidation index,UHMWPE