ASTM F2848-17

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

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  
Test Methods D792 or D1505  
0.95 - 1.00  
Melting temperature – peak, °C  
Test Method F2625  
140 - 150  
Filament Linear Density, dtex (Maximum)  
6.3  
2.7  
Intrinsic Viscosity, dl/g (Minimum)  
6.4  
15  
Tensile Strength, cN/dtex (Minimum)  
6.5  
26  
Tensile Modulus, cN/dtex (Minimum)  
6.5  
750  
Elongation-at-break, %  
6.5  
2 - 5  
Additional requirement for colored yarn:  
Pigment content, wt.% (Maximum)
Chromium-cobalt-aluminum oxide  
6.2  
2  
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: Historical
• Publication Date: 30-Apr-2017
• 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2848 −17
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
F748 PracticeforSelectingGenericBiologicalTestMethods
fabricated from the components specified herein.
for Materials and Devices
F756 Practice for Assessment of Hemolytic Properties of
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this Materials
F2625 Test Method for Measurement of Enthalpy of Fusion,
standard.
Percent Crystallinity, and Melting Point of Ultra-High-
1.4 This standard does not purport to address all of the
Molecular Weight Polyethylene by Means of Differential
safety concerns, if any, associated with its use. It is the
Scanning Calorimetry
responsibility of the user of this standard to establish appro-
3
2.2 ISO Standards:
priate safety and health practices and determine the applica-
ISO 1628-3 Plastics—Determination of the Viscosity of
bility of regulatory limitations prior to use.
Polymers in Dilute Solution Using Capillary
1.5 This international standard was developed in accor-
Viscometers—Part 3: Polyethylenes and Polypropylenes
dance with internationally recognized principles on standard-
ISO 2062 Textiles—Yarns from Packages—Determination
ization established in the Decision on Principles for the
of Single-end Breaking Force and Elongation at Break
Development of International Standards, Guides and Recom-
ISO10993-1 BiologicalEvaluationofMedicalDevicesPart
mendations issued by the World Trade Organization Technical
1 – Evaluation and testing within a risk management
Barriers to Trade (TBT) Committee.
processs
ISO 10993-4 Biological Evaluation of Medical Devices Part
2. Referenced Documents
4 – Selection of tests for interactions with blood
2
2.1 ASTM Standards:
ISO 10993-5 Biological Evaluation of Medical Devices Part
5 – Tests for in vitro cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices –
1
This specification is under the jurisdiction of ASTM Committee F04 on
Part 10: Tests for irritation and skin sensitization
Medical and Surgical Materials and Devices and is the direct responsibility of
ISO 10993-17 Biological Evaluation of Medical Devices
Subcommittee F04.11 on Polymeric Materials.
Part 17 – Establishment for allowable limits for leachable
CurrenteditionapprovedMay1,2017.PublishedJuly2017.Originallyapproved
in 2010. Last previous edition approved in 2016 as F2848–16. DOI: 10.1520/ substances
F2848–17.
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

---------------------- Page: 1 ----------------------
F2848−17
TABLE 1 Requirements for UHMWPE Yarns
Property Test Method Requirement
3
Density, g/cm Test Methods D792 or D1505 0.95 - 1.00
Melting temperature – peak, °C Test Method F2625 14
...

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 − 16 F2848 − 17
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
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.
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
D1907/D1907M Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method
D2256/D2256M Test Method for Tensile Properties of Yarns by the Single-Strand Method
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F756 Practice for Assessment of Hemolytic Properties of Materials
F2625 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
3
2.2 ISO Standards:
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
ISO 10993-1 Biological Evaluation of Medical Devices Part 1 – Evaluation and testing within a risk management processs
ISO 10993-4 Biological Evaluation of Medical Devices Part 4 – Selection of tests for interactions with blood
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 Jan. 1, 2016May 1, 2017. Published March 2016July 2017. Originally approved in 2010. Last previous edition approved in 20102016 as
F2848–10.–16. DOI: 10.1520/F2848–16.10.1520/F2848–17.
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.
3
Available from International Organization for Standardization (ISO), 1, ch. de la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://www.iso.ch.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2848 − 17
TABLE 1 Requirements for UHMWPE Yarns
Property Test Method Requirement
3
Density, g/cm Test Methods D792 or D1505 0.95 - 1.00
Melting temperature – pea
...