ASTM F2848-17
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

Standard No.
ASTM F2848-17
Release Date
2017
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM F2848-21
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 This standard is intended to describe the requirements and the procedures to be followed for testing UHMWPE yarns as a component for medical devices prior to manufacturing processes of the medical device such as fabric formation, assembling and sterilization. This specification does not purport to address the requirements for the finished medical devices or the testing that is needed for medical devices that are fabricated from the components specified herein.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 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.

TABLE 1 Requirements for UHMWPE Yarns

Property

Test Method

Requirement

Density, g/cm3

T

ASTM F2848-17 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
  • ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
  • ASTM D885/D885M Standard Test Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from Manufactured Organic-Base Fibers
  • 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 F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
  • 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
  • ISO 8 Information and documentation — Presentation and identification of periodicals

ASTM F2848-17 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
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns


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