ASTM F 2381 : 2019
Current
The latest, up-to-date edition.
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
Hardcopy , PDF
English
01-10-2019
Committee |
F 04
|
DocumentType |
Test Method
|
Pages |
5
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
Supersedes |
1.1This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2This test method is based on Guide F2102.
1.3The 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 sample’s thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F 2759 : 2011 | Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
ASTM F 2565 : 2013 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
ASTM E 1421 : 1999 : R2021 | Standard Practice for Describing and Measuring Performance of Fourier Transform Mid-Infrared (FT-MIR) Spectrometers: Level Zero and Level One Tests |
ASTM E 691 : 2020 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
ASTM E 1421 : 1999 : R2015 : EDT 1 | Standard Practice for Describing and Measuring Performance of Fourier Transform Mid-Infrared (FT-MIR) Spectrometers: Level Zero and Level One Tests |
ASTM E 691 : 2019 : EDT 1 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
ASTM E 691 : 2023 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
ASTM E 691 : 2022 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
ASTM E 691 : 2009 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
ASTM E 691 : 2021 | Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method |
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