ASTM F2214-23 PDF
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 6
- Дата публикации:
- 1 сентября 2023 г.
- Издание:
- F2214
- ICS:
- 83.080.01
SIGNIFICANCE AND USE 5.1 This test method is designed to produce data indicative of the degree of crosslinking in ultra high molecular weight polyethylene that has been crosslinked chemically or by ionizing radiation. 5.2 The results are sensitive to the test temperature, solvent, and method used. For the comparison of data between institutions, care must be taken to have the same test conditions and reagents. 5.3 The data can be used for dose uniformity analysis, fundamental research, and quality assurance testing. SCOPE 1.1 This test method describes how the crosslink density, molecular weight between crosslinks, and number of repeat units between crosslinks in ultra high molecular weight polyethylene (UHMWPE) crosslinked by ionizing radiation or by chemical means can be determined by measuring the swelling ratio of samples immersed in o-xylene. Examples of experimental techniques used to make these measurements are discussed herein. 1.2 The test method reported here measures the change in height of a sample specimen while it is immersed in the solvent. Volumetric swell ratios assume that the sample is crosslinked isotropically, and that the change in dimension will be uniform in all directions. This technique avoids uncertainty induced by solvent evaporation or temperature change. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This 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.
Abstract
Overview
ASTM F2214-23 - Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) - defines procedures for assessing key network parameters of crosslinked UHMWPE materials. This method is essential in measuring and understanding the degree of crosslinking, molecular weight between crosslinks, and the number of repeat units between crosslinks in materials processed via ionizing radiation or chemical means. By employing swelling measurements in o-xylene at controlled temperatures, laboratories can generate repeatable data to support dose uniformity analysis, research, and quality assurance testing in UHMWPE.
This standard is especially relevant for industries that rely on the superior wear resistance and mechanical properties of crosslinked UHMWPE, such as medical devices and industrial components.
Key Topics
The ASTM F2214-23 standard covers the following essential areas:
- Crosslink Density Measurement: Determines the average number of crosslinks in UHMWPE per unit volume, informing about network structure and expected performance.
- Molecular Weight between Crosslinks: Calculates the average molecular weight segment between crosslinks, a key parameter for predicting physical and mechanical behavior.
- Swelling Ratio Assessment: Uses the ratio of the volume of a swollen specimen to its dry state in o-xylene to derive network parameters using Flory’s network theory.
- Test Methodology: Describes sample preparation, solvent selection, test apparatus, temperature control, and measurement processes to ensure consistent results.
- Interlaboratory Repeatability: Addresses factors essential for consistent comparison of results between laboratories, emphasizing the importance of uniform test conditions, particularly test temperature and solvent used.
Applications
The test method outlined in ASTM F2214-23 is widely utilized in several practical contexts:
- Medical Device Manufacturing: Used extensively for orthopedic implant components, particularly in quality control of joint replacements, to ensure reliable wear resistance and longevity.
- Material Research and Development: Supports fundamental research into the effects of crosslinking on UHMWPE properties, enabling optimization of processing techniques.
- Quality Assurance: Provides a robust approach for manufacturers to verify the crosslinking degree and uniformity in each batch, reducing variability and improving product performance.
- Dose Uniformity Studies: Essential for validating and calibrating irradiation and chemical crosslinking processes, ensuring homogeneous material properties throughout the product.
- Regulatory Compliance: Offers a standardized method recognized across the global industry, supporting compliance with international norms and technical barriers to trade.
Related Standards
Several ASTM standards are referenced or related to ASTM F2214-23, including:
- ASTM D2765: Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics.
- ASTM E177: Practice for Use of the Terms Precision and Bias in ASTM Test Methods.
- ASTM E691: Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method.
These standards support enhanced reliability and comparability of test data across different laboratories and applications.
Keywords: ASTM F2214-23, UHMWPE, crosslink density, network parameters, molecular weight between crosslinks, swelling ratio, in situ determination, quality assurance, medical device materials, standard test method, o-xylene, interlaboratory reproducibility, polymer testing.
For further information or to access the official ASTM F2214-23 standard, visit the ASTM International website.
Технические детали
- Технический комитет
- F04 - Medical and Surgical Materials and Devices
- SKU
- ASTM F2214-23
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