ASTM F2848-21
Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns

Standard No.

ASTM F2848-21

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2848-21

Scope

1.1?This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) and pigmented (colored) yarns. 1.2

ASTM F2848-21 Referenced Document

• ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
• ASTM D1601 Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers
• ASTM D1907/D1907M Standard Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method
• ASTM D2256/D2256M Standard Test Method for Tensile Properties of Yarns by the Single-Strand Method*， 2021-07-01 Update
• ASTM D5630 Standard Test Method for Ash Content in Thermoplastics
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• ASTM D8171 Standard Test Methods for Density Determination of Flax Fiber
• ASTM D885/D885M Standard Test Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from Manufactured Organic-Base Fibers*， 2024-04-20 Update
• ASTM E1131 Standard Test Method for Compositional Analysis by Thermogravimetry
• 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*， 2024-04-20 Update
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 13485 
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 1628-3 Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometers - Part 3: Polyethylenes and polypropylenes
• ISO 2062 Textiles - Yarns from packages - Determination of single-end breaking force and elongation at break using constant rate of extension (CRE) tester

ASTM F2848-21 history

• 2021 ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• 2017 ASTM F2848-17 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
• 2016 ASTM F2848-16 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
• 2010 ASTM F2848-10 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns