ASTM F648-21
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Standard No.

ASTM F648-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F648-21

Scope

1.1?This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants. 1.2?The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is an

ASTM F648-21 Referenced Document

• ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
• ASTM D1898 
• ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics*， 2023-03-15 Update
• ASTM D4020 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D648 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position*， 2024-04-22 Update
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-22 Update
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• 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 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 11542-2 Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties; Technical Corrigendum 1
• ISO 13485 
• ISO 3451-1 Plastics — Determination of ash — Part 1: General methods
• ISO 9001 Quality management systems - Requirements [Spanish version]

ASTM F648-21 history

• 2021 ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2014 ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2013 ASTM F648-13 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2010 ASTM F648-10a Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2010 ASTM F648-10 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2007 ASTM F648-07e1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2007 ASTM F648-07 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2004 ASTM F648-04 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2000 ASTM F648-00e1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 2000 ASTM F648-00 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants