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This guide covers extensively irradiation-crosslinked ultra-high molecular weight polyethylene (UHMWPE) fabricated forms for surgical implant applications. Only gamma and electron beam irradiated extensively crosslinked materials are covered by this guide. Chemical composition and physical properties of extensively crosslinked UHMWPE fabricated form shall conform to the requirements of this guide which include ultimate tensile strength, yield strength, elongation, Izod impact strength, ultimate load, fatigue crack propagation, compressive modulus, percent crystallinity, melting temperature, residual free radicals, swell ratio, oxidation index, and t-vinylene content. Biocompatibility of the material shall also be considered when new applications of the material, or modification to the material or physical forms of the materials are being contemplated.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification .
1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.
1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.
1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.
1.5 The following precautionary caveat pertains only to the test method portion, Section 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. , of this guide:
1.6 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardISO 10993-1 Biological Evaluation of Medical DevicesPart 1: Evaluation and testing within a risk management process
D695 Test Method for Compressive Properties of Rigid Plastics
D1898 Practice for Sampling of Plastics
D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
E647 Test Method for Measurement of Fatigue Crack Growth Rates
F619 Practice for Extraction of Materials Used in Medical Devices
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2102 Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
F2214 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
F2381 Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
F2625 Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
F2759 Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
F2977 Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.10 (Thermosetting materials)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F2565-21, Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top