ASTM F2848-16

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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Dec-2015
• 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

• Replaces: ASTM F2848-10 - Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
• Effective Date: 01-Jan-2016
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Jan-2016

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 −16
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 D1601 Test Method for Dilute Solution Viscosity of Ethyl-
ene Polymers
1.1 This specification covers ultra-high molecular weight
D1907/D1907M Test Method for Linear Density of Yarn
polyethylene (UHMWPE) yarns intended for use in medical
(Yarn Number) by the Skein Method
devices or components of medical devices, such as sutures and
D2256/D2256M Test Method forTensile Properties ofYarns
ligament fixations. This specification covers natural (non-
by the Single-Strand Method
colored) and pigmented (colored) yarns.
F748 PracticeforSelectingGenericBiologicalTestMethods
1.2 This standard is intended to describe the requirements
for Materials and Devices
and the procedures to be followed for testing UHMWPE yarns
F756 Practice for Assessment of Hemolytic Properties of
as a component for medical devices prior to manufacturing
Materials
processes of the medical device such as fabric formation,
F2625 Test Method for Measurement of Enthalpy of Fusion,
assembling and sterilization. This specification does not pur-
Percent Crystallinity, and Melting Point of Ultra-High-
port to address the requirements for the finished medical
Molecular Weight Polyethylene by Means of Differential
devicesorthetestingthatisneededformedicaldevicesthatare
Scanning Calorimetry
fabricated from the components specified herein.
3
2.2 ISO Standards:
1.3 The values stated in SI units are to be regarded as
ISO 1628-3 Plastics—Determination of the Viscosity of
standard. No other units of measurement are included in this
Polymers in Dilute Solution Using Capillary
standard.
Viscometers—Part 3: Polyethylenes and Polypropylenes
ISO 2062 Textiles—Yarns from Packages—Determination
1.4 This standard does not purport to address all of the
of Single-end Breaking Force and Elongation at Break
safety concerns, if any, associated with its use. It is the
ISO10993-1 BiologicalEvaluationofMedicalDevicesPart
responsibility of the user of this standard to establish appro-
1 – Evaluation and testing within a risk management
priate safety and health practices and determine the applica-
processs
bility of regulatory limitations prior to use.
ISO 10993-4 Biological Evaluation of Medical Devices Part
2. Referenced Documents
4 – Selection of tests for interactions with blood
2
ISO 10993-5 Biological Evaluation of Medical Devices Part
2.1 ASTM Standards:
5 – Tests for in vitro cytotoxicity
D792 Test Methods for Density and Specific Gravity (Rela-
ISO 10993-10 Biological Evaluation of Medical Devices –
tive Density) of Plastics by Displacement
Part 10: Tests for irritation and skin sensitization
D885/D885M Test Methods for Tire Cords, Tire Cord
ISO 10993-17 Biological Evaluation of Medical Devices
Fabrics, and Industrial Filament Yarns Made from Manu-
Part 17 – Establishment for allowable limits for leachable
factured Organic-Base Fibers
substances
D1505 Test Method for Density of Plastics by the Density-
ISO 10993-18 Biological Evaluation of Medical Devices
Gradient Technique
Part 18 – Chemical characterization of materials
ISO 13485 Medical Devices – Quality Management Sys-
1
This specification is under the jurisdiction of ASTM Committee F04 on
tems – Requirements for regulatory purposes
Medical and Surgical Materials and Devices and is the direct responsibility of
ISO 14971 Medical Devices – Application of risk manage-
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Jan. 1, 2016. Published March 2016. Originally ment to Medical Devices
approved in 2010. Last previous edition approved in 2010 as F2848–10. DOI:
10.1520/F2848–16.
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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F2848−16
2.3 Other Documents: acteristics for the identified potential toxic ingredients should
ICH Q3C(R3) International Conference on Harmonisation be performed in accordance with 4.4 to establish a maximum
ofTechnicalRequir
...

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 − 10 F2848 − 16
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 required properties requirements and the procedures to be followed for testing
UHMWPE yarns as raw materials for medical devices. 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 or components of medical devices
that are fabricated from the raw materials 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 The following precautionary caveat pertains only to the test method portion, Section 6, of this specification: 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D885D885/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
D1907D1907/D1907M Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method
D2256D2256/D2256M Test Method for Tensile Properties of Yarns by the Single-Strand Method
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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 1099310993-1 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 June 1, 2010Jan. 1, 2016. Published July 2010March 2016. Originally approved in 2010. Last previous edition approved in 2010 as F2848–10.
DOI: 10.1520/F2848–10.10.1520/F2848–16.
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 − 16
ISO 10993-5 Biological Evaluation of Medical Devices Part 5 – Tests for in vitro cytotoxicity
ISO 10993-10 Biological Evaluation of Medica
...