Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-01-2019

Publisher

American Society for Testing and Materials

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.

Committee	F 04
DocumentType	Test Method
Pages	5
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 2381 : 2010

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