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ASTM F 2102 : 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Superseded by

ASTM F 2102 : 2017

Language(s)

English

Published date

01-11-2013

€67.30
Excluding VAT

Committee
F 04
DocumentType
Guide
Pages
5
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1This guide 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.

1.2Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics.

1.3

Typical FTIR Spectra of Oxidized UHMWPE, Showing theDefinition of an Area-Based Oxidation Index Based on NormalizationUsing the 1370-cm Peak
FIG. 1Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm -1 Peak
FTIR Spectra Showing the Carbonyl Absorption Bands
FIG. 2FTIR Spectra Showing the Carbonyl Absorption Bands
Note 1Note that both reagents effectively extracted the lipids (the lipid absorption peak is centered at approximately 1740 cm-1). The tibial insert was fabricated from highly crosslinked and remelted UHMWPE followed by terminal sterilization in EtO gas (Ref. 1).
The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample's thickness, has been validated by an Interlaboratory Study (ILS) conducted according to Practice E691.

1.4The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard may involve hazardous materials, operations, and equipment. 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 requirements prior to use.

ASTM F 2759 : 2011 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2381 : 2010 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
ASTM F 2977 : 2013 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 2565 : 2013 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

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