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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 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 DocumentsICH Q3C(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 StandardsISO 10993 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)
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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