ASTM F2565-13
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- Standard No.
- ASTM F2565-13
- Release Date
- 2013
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2565-21
- Latest
- ASTM F2565-21
- Scope
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 Test Method F648.
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 5, of this guide. 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.
ASTM F2565-13 Referenced Document
- ASTM D1898
- ASTM D2765 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
- ASTM D638 Standard Test Method for Tensile Properties of Plastics
- ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
- ASTM E647 Standard Test Method for Measurement of Fatigue Crack Growth Rates
- ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
- ASTM F2102 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
- ASTM F2183 Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
- ASTM F2214 Standard Test Method for
In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) - ASTM F2381 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 F2625 Standard 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
- ASTM F2759 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
- ASTM F619 Standard Practice for Extraction of Medical Plastics
- ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F749 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
- ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 527 Plastics — Determination of tensile properties — Part 5: Test conditions for unidirectional fibre-reinforced plastic composites
ASTM F2565-13 history
- 2021 ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- 2013 ASTM F2565-13 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- 2006 ASTM F2565-06 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
