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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.
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.
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 Test Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from Manufactured Organic-Base Fibers
D1907 Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method
D2256 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
Other DocumentsICHQ3C(R3) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline: Impurities: Residual SolventsAvailable from International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, http://www.ich.org.
ISO StandardsISO10993 Biological Evaluation of Medical Devices
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)