ASTM F2381-04
Historical Standard: ASTM F2381-04 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
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ASTM F2381
1. Scope
1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2 This test method is based on Guide F 2102.
1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm -1 to normalize for the samples thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E 691.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1421 Practice for Describing and Measuring Performance of Fourier Transform Mid-Infrared (FT-MIR) Spectrometers: Level Zero and Level One Tests
F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
Keywords
crosslinking; FTIR (Fourier Transform Infrared); implant; trans-vinylene index; TVI; UHMWPE (ultra-high molecular weight polyethylene); Infrared (IR) analysis; Surgical implants; Trans-vinylene yield; Ultra-high molecular-weight polyethylene (UHMWPE) ;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F2381-04
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