ASTM F2848-10

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.
1.2 This standard is intended to describe the required properties and the procedures to be followed for testing UHMWPE yarns as raw materials for medical devices. This specification does not purport to address the testing that is needed for medical devices or components of medical devices that are fabricated from the raw materials 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.

General Information

• Status: Historical
• Publication Date: 31-May-2010
• 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

• Replaced By: ASTM F2848-16 - 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-Jun-2010

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −10
StandardSpecification 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 Single-Strand Method
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.1 This specification covers ultra-high molecular weight
ethylene Powder and Fabricated Form for Surgical Im-
polyethylene (UHMWPE) yarns intended for use in medical
plants
devices or components of medical devices, such as sutures and
F748 PracticeforSelectingGenericBiologicalTestMethods
ligament fixations.
for Materials and Devices
1.2 This standard is intended to describe the required
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2.2 ISO Standards:
properties and the procedures to be followed for testing
ISO 1628-3 Plastics—Determination of the Viscosity of
UHMWPE yarns as raw materials for medical devices. This
Polymers in Dilute Solution Using Capillary
specification does not purport to address the testing that is
Viscometers—Part 3: Polyethylenes and Polypropylenes
needed for medical devices or components of medical devices
ISO 2062 Textiles—Yarns from Packages—Determination
that are fabricated from the raw materials specified herein.
of Single-end Breaking Force and Elongation at Break
1.3 The values stated in SI units are to be regarded as
ISO 10993 Biological Evaluation of Medical Devices
standard. No other units of measurement are included in this
2.3 Other Documents:
standard.
ICH Q3C(R3) International Conference on Harmonisation
1.4 The following precautionary caveat pertains only to the ofTechnicalRequirementsforRegistrationofPharmaceu-
test method portion, Section 6, of this specification: This
ticals for Human Use, Quality Guideline: Impurities:
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standard does not purport to address all of the safety concerns, Residual Solvents
if any, associated with its use. It is the responsibility of the user
3. Terminology
of this standard to establish appropriate safety and health
practices and determine the applicability of regulatory limita-
3.1 Definitions of Terms Specific to This Standard:
tions prior to use.
3.1.1 UHMWPE filament—molecularly oriented highly
crystalline fiber spun from virgin UHMWPE polymer powder.
2. Referenced Documents
3.1.2 UHMWPE yarn—a continuous strand of more than
2
2.1 ASTM Standards:
one UHMWPE filaments in a form suitable for operations such
D792 Test Methods for Density and Specific Gravity (Rela-
as weaving, knitting, etc., prior to packaging and sterilization.
tive Density) of Plastics by Displacement
3.1.3 linear density—mass per length, expressed in dtex
D885 Test Methods for Tire Cords, Tire Cord Fabrics, and
(mass in grams per 10 000 metres).
Industrial Filament Yarns Made from Manufactured
3.1.3.1 Discussion—Tex is a unit of measure for the linear
Organic-Base Fibers
mass density of yarns and is defined as the mass in g/1000 m.
D1907 Test Method for Linear Density of Yarn (Yarn Num-
Because of the low mass of yarns used in medical applications,
ber) by the Skein Method
decitex (abbreviated as dtex) is more commonly used, and is
D2256 Test Method for Tensile Properties of Yarns by the
mass in g/10 000 m. Another related unit of measure for the
linear mass density is denier, which is defined as g/9000 m.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3
Subcommittee F04.11 on Polymeric Materials. Available from International Organization for Standardization (ISO), 1, ch. de
Current edition approved June 1, 2010. Published July 2010. DOI: 10.1520/ la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
F2848–10. www.iso.ch.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Conference on Harmonisation of Technical
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Standards volume information, refer to the standard’s Document Summary page on Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
the ASTM website. Switzerland, http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2848−10
3.1.4 production liquid—any liquid(s) used in the produc- 5. Sampling
tion of the filaments and yarns, such as solvents and extraction
5.1 Compliance with this specification shall be determined
solutions.
by
...