ASTM F2565-21
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

Standard No.

ASTM F2565-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

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 Specification F648. 1.2?This guide does not c

ASTM F2565-21 Referenced Document

• ASTM D1898 
• ASTM D2765 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene 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*， 2022-11-15 Update
• ASTM F2102 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
• ASTM F2214 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)*， 2023-09-01 Update
• 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*， 2024-03-15 Update
• ASTM F2759 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• ASTM F2977 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
• 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 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ASTM F2565-21 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