ASTM F2102-13

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

STANDARD published on 1.11.2013

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The information about the standard:

Designation standards: ASTM F2102-13
Note: WITHDRAWN
Publication date standards: 1.11.2013
SKU: NS-52838
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F2102-13 :

Keywords:
FTIR, implant, oxidation, oxidation index, UHMWPE, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This 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.

1.2 Although 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

FIG. 1 Typical FTIR Spectra of Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation Index Based on Normalization Using the 1370-cm ^-1 Peak

FIG. 2 FTIR Spectra Showing the Carbonyl Absorption Bands

1.4 The 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.

2. Referenced Documents

E691-23

Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method