ASTM F2848-10
(Specification)Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
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.
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Designation:F2848 −10
StandardSpecification for
Medical-Grade Ultra-High 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 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
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:
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
2.1 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.
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. 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 service@astm.org. 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
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 sampling sizes and procedures as agreed upon between the
purchaser and seller.
4. UHMWPE Filament and Yarn Requirements
4.1 Compositional Requirements:
6. Test Methods
4.1.1 Current yarns used for medical application with clini-
6.1 Residual production liquids shall be determined by gas
calhistoryareproducedwithdecalinassolvent.Themaximum
chromatography or other suitable, validated analytical methods
decalin residual level is 100 mg/kg (see 6.1).
for the specific materials used to produce the yarn.
4.1.2 In case other production liquids are used, the accept-
able residual levels of these particular production liquid(s) 6.2 Determine the trace element concentrations of titanium,
shall be reflective of toxicity, with a maximum acceptable limit sodium, chromium, iron, and calcium by a validated analytical
consistent with ICH Q3C(R3). If no ICH concentration guide- method, such as neutron activation analysis (NAA), induc-
line has been established for a utilized production liquid, proof tively coupled plasma spectroscopy (ICP), atomic absorption
of biocompatibility has to be given.
(AA), or X-ray fluorescence (XRF).
4.1.3 To promote consistency in production and pureness of
6.3 Determine filament linear density by dividing the yarn
the yarn, concentration limits for trace elements have been
linear density, measured according to Test Method D1907,by
established and are listed in Table 1.
the number of filaments in the yarn.
4.2 Physical Requirements:
6.4 The intrinsic viscosity shall be measured according to
4.2.1 The density of the yarn shall comply with the require-
ISO 1628-3, but in the case of incomplete dissolution of the
ment listed in Table 1.
polymer, longer dissolution times and/or lower dissolution
4.2.2 The linear density requirement of single filaments is
temperatures can be applied.
listed in Table 1.
6.5 Determine tensile strength, tensile modulus and
4.2.3 The intrinsic viscosity requirement for the UHMWPE
elongation-at-breakastheaverageof15samplestestedaccord-
yarn is listed in Table 1.
ingtothefollowingtestconditions,derivedfromTestMethods
4.3 Mechanical Requirements:
D885, Test Method D2256, and ISO 2062, and optimized for
4.3.1 UHMWPE yarns shall meet the tensile requirements
UHMWPE yarns:
on strength, modulus and elongation-at-break as listed in Table
6.5.1 Test Conditions:
1. Note that tensile properties of the final medical device
6.5.1.1 Temperature shall be 21 6 1°C, at a relative
depend on the construction of yarns used therein.
humidity between 40 and 75 %.
4.4 Biocompatibility Requirements:
6.5.1.2 Twisting level shall be according to product
4.4.1 The UHMWPE yarn shall be biocompatible. While
specifications, and any change in twist shall be avoided.
the biocompatibility of UHMWPE powder and fibers has been
6.5.1.3 Touching of the test specimen with bare hands shall
characterized (1-8), this data cannot be assumed to be appro-
be avoided.
priate for all uses of UHMWPE.When new applications of the
6.5.1.4 Special care shall be taken to avoid slippage of the
material, or modifi
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