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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
ICS Number Code 11.040.30 (Surgical instruments and materials); 83.080.20 (Thermoplastic materials)
UNSPSC Code 42291802(Surgical clamps or clips or forceps or accessories); 13101723(Thermoplastic)
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ASTM F2848-16, Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns, ASTM International, West Conshohocken, PA, 2016, www.astm.orgBack to Top