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ASTM F2848-10

Historical Revision

Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns

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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.

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.


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.


SDO ASTM: ASTM International
Document Number F2848
Publication Date June 1, 2010
Language en - English
Page Count 4
Revision Level 10
Supercedes
Committee F04.11
Publish Date Document Id Type View
June 1, 2021 F2848-21 Revision
May 1, 2017 F2848-17 Revision
Jan. 1, 2016 F2848-16 Revision
June 1, 2010 F2848-10 Revision