ASTM F2848-21

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

ABSTRACT
This specification describes the required properties and the procedures to be followed for testing ultra-high molecular weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. UHMWPE filament and yarn requirements cover compositional requirements, physical requirements, mechanical requirements, and biocompatibility requirements. Residual production liquids shall be determined by gas chromatography or other suitable, validated analytical methods for the specific materials used to produce the yarn.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-May-2021
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 83.080.20 - Thermoplastic materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Refers: ASTM E1131-20 - Standard Test Method for Compositional Analysis by Thermogravimetry
• Effective Date: 15-Mar-2020

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F2848 −21
Standard Specification for
Medical-Grade Ultra-High-Molecular-Weight Polyethylene
1
Yarns
This standard is issued under the fixed designation F2848; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D792 Test Methods for Density and Specific Gravity (Rela-
tive Density) of Plastics by Displacement
1.1 This specification covers ultra-high-molecular-weight
D885/D885M Test Methods for Tire Cords, Tire Cord
polyethylene (UHMWPE) yarns intended for use in medical
Fabrics, and Industrial Filament Yarns Made from Manu-
devices or components of medical devices, such as sutures and
factured Organic-Base Fibers
ligament fixations. This specification covers natural (non-
D1505 Test Method for Density of Plastics by the Density-
colored) and pigmented (colored) yarns.
Gradient Technique
1.2 This standard is intended to describe the requirements
D1601 Test Method for Dilute Solution Viscosity of Ethyl-
and the procedures to be followed for testing UHMWPE yarns
ene Polymers
as a component for medical devices prior to manufacturing
D1907/D1907M Test Method for Linear Density of Yarn
processes of the medical device such as fabric formation,
(Yarn Number) by the Skein Method
assembling, and sterilization. This specification does not pur-
D2256/D2256M Test Method forTensile Properties ofYarns
port to address the requirements for the finished medical
by the Single-Strand Method
devicesorthetestingthatisneededformedicaldevicesthatare
D5630 Test Method for Ash Content in Plastics
fabricated from the components specified herein.
D8171 Test Methods for Density Determination of Flax
Fiber
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this E1131 Test Method for CompositionalAnalysis by Thermo-
gravimetry
standard.
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.4 This standard does not purport to address all of the
ethylene Powder and Fabricated Form for Surgical Im-
safety concerns, if any, associated with its use. It is the
plants
responsibility of the user of this standard to establish appro-
F756 Practice for Assessment of Hemolytic Properties of
priate safety, health, and environmental practices and deter-
Materials
mine the applicability of regulatory limitations prior to use.
F2625 Test Method for Measurement of Enthalpy of Fusion,
1.5 This international standard was developed in accor-
Percent Crystallinity, and Melting Point of Ultra-High-
dance with internationally recognized principles on standard-
Molecular Weight Polyethylene by Means of Differential
ization established in the Decision on Principles for the
Scanning Calorimetry
Development of International Standards, Guides and Recom-
3
mendations issued by the World Trade Organization Technical 2.2 ISO Standards:
ISO 1628-3 Plastics—Determination of the Viscosity of
Barriers to Trade (TBT) Committee.
Polymers in Dilute Solution Using Capillary
Viscometers—Part 3: Polyethylenes and Polypropylenes
2. Referenced Documents
2 ISO 2062 Textiles—Yarns from Packages—Determination
2.1 ASTM Standards:
of Single-end Breaking Force and Elongation at Break
ISO 10993-1 Biological Evaluation of Medical Devices—
Part 1: Evaluation and testing within a risk management
1
This specification is under the jurisdiction of ASTM Committee F04 on
processs
Medical and Surgical Materials and Devices and is the direct responsibility of
ISO 10993-4 Biological Evaluation of Medical Devices—
Subcommittee F04.11 on Polymeric Materials.
Current edition approved June 1, 2021. Published June 2021. Originally Part 4: Selection of tests for interactions with blood
approved in 2010. Last previous edition approved in 2017 as F2848 – 17. DOI:
10.1520/F2848-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from International Organization for Standardization (ISO), 1, ch. de
Standards volume information, refer to the standard’s Document Summary page on la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
the ASTM website. www.iso.ch.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2848−21
ISO 10993-5 Biological Evaluation of Medical Devices— 3.1.4 UHMWPE yarn—a continuous strand of more than
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2848 − 17 F2848 − 21
Standard Specification for
Medical-Grade Ultra-High Molecular Weight Ultra-High-
1
Molecular-Weight Polyethylene Yarns
This standard is issued under the fixed designation F2848; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification covers ultra-high molecular weight 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.
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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D885/D885M Test Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from Manufactured
Organic-Base Fibers
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1601 Test Method for Dilute Solution Viscosity of Ethylene Polymers
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved May 1, 2017June 1, 2021. Published July 2017June 2021. Originally approved in 2010. Last previous edition approved in 20162017 as
F2848F2848 – 17.–16. DOI: 10.1520/F2848–17.10.1520/F2848-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2848 − 21
TABLE 1 Requirements for UHMWPE Yarns
Property Test Method Requirement
Property Requirement Test Method
3
Density, g/cm Test Methods D792 or D1505 0.95 - 1.00
3
Density, g/cm 0.95–1.00 See 6.6
Melting temperature – peak, °C Test Method F2625 140 - 150
Melting temperature – peak, °C 140–150 Test Method F2625
Filament Linear Density, dtex (Maximum) 6.3 2.7
Filament Linear Density, dtex (Maximum) 2.7 See 6.3
Intrinsic Viscosity, dl/g (Minimum) 6.4 15
Intrinsic Viscosity, dl/g (Minimum) 15 See 6.4
Tensile Strength, cN/dtex (Minimum) 6.5 26
Tensile Strength, cN/dtex (Minimum) 26 See 6.5
Tensile Modulus, cN/dtex (Minimum) 6.5 750
Tensile Modulus, cN/dtex (Minimum) 750 See 6.5
Elongation-at-break, % 6.5 2 - 5
Elongation-at-break, % 2–5 See 6.5
Additional requirement for colored yarn:
Pigment content, wt.% (Maximum) 2
Chromium-cobalt-aluminum oxide 6.2
Pigment content, wt.% (Maximum)
Chromium-cobalt-aluminum oxide 2 See 6.2
D&C Black No. 4 1.0 See 6.7
D1907/D19
...