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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.

Significance and Use

Published literature shows that the yield of radiolytic reactions that occur during radiation treatment increases with radiation dose level. Measurement of the products of these reactions can be used as an internal dosimeter.

Trans-vinylene unsaturations are formed during ionization treatment by abstraction of a hydrogen molecule, and to a lesser extent by the recombination of two adjacent alkyl free radicals that reside on the same chain.

Previous work generated calibration curves of trans-vinylene absorption area as a function of absorbed radiation dose, yielding a linear relationship for both gamma- and electron beam-irradiated polyethylene.

This data can be used to determine received dose as a function of position, assuming a calibration curve (TVI versus radiation dose level) is known for the particular material and radiation conditions used, and can be used to determine uniformity of dose level in irradiated polyethylene.

Keywords

crosslinking; FTIR (Fourier Transform Infrared); implant; trans-vinylene index; TVI; UHMWPE (ultra-high-molecular-weight-polyethylene); ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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