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 − 17

Standard Specification for

Medical-Grade Ultra-High Molecular Weight Polyethylene
Yarns1
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-
1.1 This specification covers ultra-high molecular weight tive Density) of Plastics by Displacement
polyethylene (UHMWPE) yarns intended for use in medical D885/D885M Test Methods for Tire Cords, Tire Cord
devices or components of medical devices, such as sutures and Fabrics, and Industrial Filament Yarns Made from Manu-
ligament fixations. This specification covers natural (non- factured Organic-Base Fibers
colored) and pigmented (colored) yarns. D1505 Test Method for Density of Plastics by the Density-
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 for Tensile Properties of Yarns
port to address the requirements for the finished medical by the Single-Strand Method
devices or the testing that is needed for medical devices that are F748 Practice for Selecting Generic Biological Test Methods
fabricated from the components specified herein. for Materials and Devices
1.3 The values stated in SI units are to be regarded as F756 Practice for Assessment of Hemolytic Properties of
standard. No other units of measurement are included in this Materials
standard. F2625 Test Method for Measurement of Enthalpy of Fusion,
1.4 This standard does not purport to address all of the Percent Crystallinity, and Melting Point of Ultra-High-
safety concerns, if any, associated with its use. It is the Molecular Weight Polyethylene by Means of Differential
responsibility of the user of this standard to establish appro- Scanning Calorimetry
priate safety and health practices and determine the applica- 2.2 ISO Standards:3
bility of regulatory limitations prior to use. ISO 1628-3 Plastics—Determination of the Viscosity of
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- ISO 10993-1 Biological Evaluation of Medical Devices Part
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
2.1 ASTM Standards:2 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.
Current edition approved May 1, 2017. Published July 2017. Originally approved Part 17 – Establishment for allowable limits for leachable
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 service@astm.org. 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

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 F2848 − 17
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) 6.2 2
Chromium-cobalt-aluminum oxide

ISO 8 Biological Evaluation of Medical Devices Part 18 – constituents can be residues from the used production liquids,
Chemical characterization of materials processing aids, or residual elements from raw materials.
ISO 13485 Medical Devices – Quality Management Sys- 4.1.2 Residual production liquids shall be assessed with
tems – Requirements for regulatory purposes regard to toxicity hazards, with a maximum acceptable limit
ISO 14971 Medical Devices – Application of risk manage- consistent with ICH Q3C(R3). If no ICH concentration guide-
ment to Medical Devices line has been established for a utilized production liquid, a
2.3 Other Documents: toxicity assessment and corresponding potential leaching char-
ICH Q3C(R3) International Conference on Harmonisation acteristics for the identified potential toxic ingredients should
of Technical Requirements for Registration of Pharmaceu- be performed in accordance with 4.4 to establish a maximum
ticals for Human Use, Quality Guideline: Impurities: residual level.
Residual Solvents4 4.1.3 Potential effects of residual production liquid(s) on
US Code of Federal Regulations—CFR section 21 Parts 70, mechanical or physical yarn properties should be considered as
71, 73, 74 and 80 on color additives for medical devices5 well for establishing maximum limits.
4.1.4 For decalin as solvent, the residual level has been
3. Terminology established in accordance with 4.4 and 4.1.3 and shall be less
3.1 Definitions of Terms Specific to This Standard: than 100 mg/kg (see 6.1).
3.1.1 UHMWPE filament—molecularly oriented highly 4.1.5 In case a color additive or pigment is added to the
crystalline fiber spun from virgin UHMWPE polymer powder. yarn, this should be compliant to the FDA regulation as
3.1.2 UHMWPE yarn—a continuous strand of more than published in the US Code of Federal Regulations - CFR section
one UHMWPE filaments in a form suitable for operations such 21, parts 70, 71, 73, 74 and 80 on color additives for medical
as weaving, knitting, etc. devices.
3.1.3 linear density—mass per length, expressed in dtex 4.2 Physical Requirements:
(mass in grams per 10 000 metres). 4.2.1 The density of the yarn shall comply with the require-
3.1.3.1 Discussion—Tex is a unit of measure for the linear ment listed in Table 1.
mass density of yarns and is defined as the mass in g/1000 m. 4.2.2 The linear density requirement of single filaments is
Because of the low mass of yarns used in medical applications, listed in Table 1.
decitex (abbreviated as dtex) is more commonly used, and is 4.2.3 The intrinsic viscosity requirement for the UHMWPE
mass in g/10 000 m. Another related unit of measure for the yarn is listed in Table 1.
linear mass density is denier, which is defined as g/9000 m. 4.3 Mechanical Requirements:
3.1.4 production liquid—any liquid(s) used in the produc- 4.3.1 Tensile testing shall be conducted after sufficient
tion of the filaments and yarns, such as solvents and extraction conditioning to the laboratory conditions, with a minimum of 2
solutions. h to achieve uniform temperatures within the yarn package.
4.3.2 UHMWPE yarns shall meet the tensile requirements
4. UHMWPE Filament and Yarn Requirements on strength, modulus, and elongation-at-break as listed for
4.1 Compositional Requirements: individual data as listed in Table 1. Note that tensile properties
4.1.1 Maximum acceptable limits for residual constituents of the final medical device depend on the construction of yarns
shall be determined based on prevention of adverse effects used therein.
when used in a medical application (see also 4.4). Residual
4.4 Biocompatibility and Biosafety Risk Assessment Re-
quirements:
4
Available from International Conference on Harmonisation of Technical 4.4.1 The first principle of ISO 10993-1 states that biologi-
Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH cal evaluation of any material or medical device intended for
Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, use in humans shall form part of a structured biological
Switzerland, http://www.ich.org.
5
evaluation program within a risk management process in
U.S. Government Publishing Office, 710 North Capitol Street N.W.,
Washington, DC (corner of North Capitol and H Streets), www.gpo.gov/about/ accordance with ISO 14971. This should be addressed through
bookstore.htm chemical characterization of the material, following ISO

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 F2848 − 17
10993-18, and toxicological assessment based on ISO 10993- be made available on a certification document for a specific
17. See the following for more specific specifications for this product yarn design and corresponding yarn manufacturing
medical-grade UHMWPE yarn: process.
4.4.1.1 The full quantitative composition of the yarn as 4.4.4 It is important to note that biological safety evaluation
component supplied should be established, including residual is a continuous process. In case of any change in yarn design
processing aids and relevant impurities or trace elements; or its manufacturing process, the yarn manufacturer should
hereinafter referred to as ingredients. evaluate the consequences on biological safety and the material
4.4.1.2 For each ingredient, a toxicological assessment master file should be updated accordingly. The user or final
should be performed based on ISO 10993-17, which means medical device manufacturer should evaluate the consequences
that Tolerable Intake (TI) values in mg/kg bw/day are derived on biological safety of any additional processes (such as, for
based on collected information on known critical adverse example, from cleaning and sterilization) and shall qualify the
effects. finished component or medical device for the intended use.
4.4.1.3 A worst-case assessment should be performed for
each ingredient. Determine whether the quantity established in 5. Sampling
4.4.1.1 is below the TI as defined in 4.4.1.2 for the application
under consideration or, if the application is unknown, for 1 g of 5.1 Compliance with this specification shall be determined
yarn (see Appendix X1.3), assuming a body weight of 70 kg by sampling sizes and procedures as agreed upon between the
and full bioavailability of the ingredients within 1 day. The 70 purchaser and seller.
kg body weight is not appropriate for pediatric and/or neonate
applications. A lower body weight is required for calculations 6. Test Methods
for these applications. 6.1 Residual production liquids shall be determined by gas
4.4.1.4 If the worst-case assessment indicates that the TI can chromatography or other suitable, validated analytical methods
be exceeded, perform extraction and/or leaching studies in for the specific liquids used to produce the yarn to a sufficient
accordance with ISO 10993–18 and determine whether the accuracy in relation to the specified value.
extracted/leached amount is below the TI for the application
under consideration or, if the application is unknown, for 1 g of 6.2 If applicable, determine concentrations of color pigment
yarn assuming a body weight of 70 kg and bioavailability of or specified trace element in accordance with 4.1 by a validated
the extracted components/leachables within 1 day. The 70 kg analytical method, such as neutron activation analysis (NAA),
body weight is not appropriate for pediatric and/or neonate inductively coupled plasma spectroscopy (ICP), atomic ab-
applications. A lower body weight is required for calculations sorption (AA), or X-ray fluorescence (XRF) to a sufficient
for these applications. accuracy in relation to the specified value.
4.4.1.5 Based on the outcome of previous steps, maximum 6.3 Determine the filament linear density by dividing the
residual levels should be set for toxicologically critical ingre- yarn linear density, measured in accordance with Test Method
dients (see 4.1). D1907/D1907M, by the number of filaments in the yarn.
4.4.2 For a proper biosafety analysis, chemical and biologi-
6.4 The intrinsic viscosity shall be measured in accordance
cal testing should always be combined, especially since not all
with ISO 1628-3 or ASTM D1601, but in the case of
potential adverse effects can be derived from toxicological
incomplete dissolution of the polymer, longer dissolution times
evaluation of only individual ingredients. As a minimum, the
and lower dissolution temperatures may be used.
following biological tests should be conducted for medical-
grade UHMWPE yarn: 6.5 Determine tensile strength, tensile modulus, and
4.4.2.1 Cytotoxicity, in accordance with ISO 10993-5. elongation-at-break in accordance with the following test
4.4.2.2 Hemolysis, in accordance with Practice F756 and conditions, derived from Test Methods D885/D885M, Test
following ISO 10993-4. Method D2256/D2256M, and ISO 2062, and optimized for
4.4.2.3 Acute Irritation, in accordance with ISO 10993-10, UHMWPE yarns:
with a preference for in vitro methods.6 6.5.1 Test Conditions:
4.4.2.4 Sensitization, in accordance with ISO 10993-10, 6.5.1.1 Temperature shall be 21 6 3°C.
with a preference for the Guinea Pig Maximization test. 6.5.1.2 Twisting level shall be in accordance with product
4.4.2.5 Results of above biological tests for the yarns cannot specifications, and any change in twist shall be avoided.
replace biological evaluation and testing in accordance with 6.5.1.3 Touching of the test specimen with bare hands shall
ISO 10993-1 for the final medical device. Additional endpoints be avoided.
may be necessary; therefore the final medical device manufac-
6.5.1.4 Special care shall be taken to avoid slippage of the
turer should evaluate the finished component or medical device
yarn in the clamps (see Appendix X2).
for the intended use in accordance with ISO 10993-1.
4.4.3 The biosafety assessment described above should be 6.5.1.5 A load cell with an accuracy of at least 61 % at the
made available in a material master file. General results should anticipated breaking force of the yarn shall be used.
6.5.1.6 Gauge length shall be 500 mm.
6
6.5.1.7 A pre-tension of 0.2 cN/dtex shall be applied at a
In vitro methods are preferred above in vivo methods to limit animal testing,
also since the medical-grade UHMWPE yarn component is not a final finished speed of 50 mm/min to remove any slack from the yarn. The
device. initial yarn length that is used in strain calculations shall be

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 F2848 − 17
adjusted accordingly; that is, the value for the initial yarn 7.3 Biosafety and biocompatibility test results and type of
length shall be the actual initial yarn length after pre- testing shall be provided in the certification or in the material
tensioning. master file on record with the FDA or notified body.
6.5.1.8 The test speed shall be constant and half the gauge
length per minute. 8. Packaging, Labeling and Storage
6.5.1.9 Force and elongation shall be recorded until yarn 8.1 UHWMPE yarn for use in medical applications shall be
breakage. supplied, shipped, and stored in proper packaging to prevent
6.5.2 For tensile strength (in cN/dtex), divide the maximum contamination during typical conditions of shipment and stor-
force-at-break (in cN) by the yarn linear density (in dtex) as age.
determined in accordance with Test Method D1907/D1907M. 8.2 All packages shall be labeled so as to identify the
6.5.3 Tensile modulus (in cN/dtex) shall be determined as manufacturer, specific product name, lot or batch number, and
the slope of the regression line to the part of the force- date of manufacturing.
elongation curve corresponding to strains between 0.3 % and
8.3 The material supplier shall provide information regard-
1.0 %, consisting of at least 45 data points. The slope (in cN)
ing recommended yarn storage conditions and shelf life of the
shall be divided by yarn linear density (in dtex) as determined
yarn.
by Test Method D1907/D1907M.
6.5.4 Elongation-at-break (in %) shall be determined by 9. Quality Control Provisions and Risk Management
dividing the increase in length after pre-tensioning until break,
9.1 UHMWPE yarn as described in the scope of this
by the initial yarn length, and multiplying by 100.
specification shall be produced in accordance with a CFR 820
or ISO 13485-certified quality management system.
7. Inspection and Certification
9.2 Design and manufacturing risks of UHMWPE yarn shall
7.1 The manufacturer shall certify that the yarn is manufac- be managed in accordance with ISO 14971.
tured according to validated processes in accordance with a
recognized quality system like CFR 820 or ISO 13485, and 10. Keywords
meets the specified requirements of this standard. 10.1 fiber; high-modulus polyethylene (HMPE); high-
7.2 The certification shall also state the colorant chemistry, performance polyethylene (HPPE); medical; surgical implants;
when present, and the specified maximum trace amount of ultra-high molecular weight polyethylene (UHMW-PE, UHM-
manufacturing residues. WPE); yarn

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 This specification is intended to describe the proper- 2 suture size or 12 m of USP 2-0 suture size and is in fact a
ties required and procedures to be followed in testing medical- worst case scenario amount.
grade UHMWPE yarns. This is different from Specification
F648, (1) which addresses UHMWPE powder and bulk shapes X1.4 The requirements of Table 1 are also based on histori-
fabricated from this powder for surgical implants. cal data from yarn products with a history of clinical use. The
listed physical requirements also assure UHMWPE yarn com-
X1.2 While the biological response to medical-grade UH- ponent identification and batch-to-batch consistency.
MWPE in soft tissue and bone has been well characterized by
a history of clinical use (2-4) and by laboratory studies (5-9), X1.5 The relationship between these mechanical properties
the data cannot necessarily be assumed to be applicable to and the in-vivo performance of a fabricated form has not been
modified forms, including UHMWPE yarns, or applications of determined. While trends are apparent, specific property-
the material. The material user should carefully analyze the polymer structure relationships are not well understood. These
published biocompatibility data and then decide whether addi- mechanical tests are frequently used to evaluate the reproduc-
tional testing may be necessary as a result of the changes which ibility of a fabrication procedure and are applicable as quality
may have been made. control tests to determine lot-to-lot repeatability for a process
of converting virgin polymer powder into a fabricated form.
X1.3 The quantity of 1 g of yarn in 4.4.1 is based on the The mechanical properties are subject to variation as the
rationale that most applications do not contain more than 1 g of fabrication process variables (such as temperature, pressure
yarn. For example, 1 g corresponds to over 4 m of braided USP and time) are changed.

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 F2848 − 17
X1.6 All properties are based on non-sterilized material, High-energy sterilization methods such as, for example,
because this standard describes a component. The recom- gamma-irradiation or e-beam irradiation are not recommended
mended method of sterilization is ethylene oxide sterilization. since they may result in a loss of properties.

X2. SUGGESTED GUIDELINE FOR CLAMPING IN TENSILE TESTING

X2.1 This guideline is intended to minimize slip of the yarn which evenly distributes the gripping force over the surface.
in the clamps during tensile testing. It is recommended to use An example of such a pneumatic yarn clamping system is the
pneumatic yarn grips especially designed to overcome the Instron type CP103684 with Instron 1498K stainless steel
problem of sample failure by incorporating a lever design faces.

REFERENCES

(1) ASTM F648, “Specification for Ultra-High-Molecular-Weight Poly- (6) Laing, P., “ Compatibility of Biomaterials,” Orthopedic Clinics of
ethylene Powder and Fabricated Form for Surgical Implants,” ASTM North America, Vol 4, No. 2, 1973.
International. (7) Escalas, F., Galante, J., Rostoker, W., “Biocompatibility of Materials
(2) Charnley, J., Cupiz, A., “The Nine and Ten Year Results of the Low for Total Joint Replacement,” Journal of Biomedical Materials
Friction Arthroplasty of the Hip,” Clinical Orthopaedics, Vol 95, No. Research, Vol 10, No. 2, 1976.
9, 1973. (8) Traoré, A. S., Guidoin, M. F., Marois, Y., Zhang, Z., Douville, Y.,
(3) Cimbrelo, E. G., Munera, L., “Early and Late Loosening of the Guidoin, R., King, M. W., Legrand, A. P., “Newly developed hybrid
Acetabular Cup After Low-Friction Arthroplasty”, The Journal of suture with lubricant: noninvasive in vivo assessment of biocompat-
Bone and Joint Surgery, Vol 74-A, No. 8, 1992. ibility with multiparametric MR imaging,” Journal of Investigative
(4) Mirra, J., Amstutz, H., Matos, M., Gold, R., “The Pathology of the
Surgery, Vol 20, No. 2, 2007.
Joint Tissues and Its Clinical Relevance in Prosthesis Failure,”
(9) Kurtz, S. M., The UHMWPE Biomaterials Handbook: Ultra-High
Clinical Orthopaedics, No. 117, 1976.
Molecular Weight Polyethylene in Total Joint Replacement and
(5) Turner, J., Lawrence, W., Autian, J., “Subacute Toxicity Testing of
Biomaterials Using Histopathologic Evaluation of Rabbit Muscle Medical Devices (2nd edition). Burlington, MA: Academic Press,
Tissue,” Journal of Biomedical Materials Research, Vol 7, 1973. 2009.

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