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. Scope

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.

ASTM Standards

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 Documents

ISO Standards

Keywords

fiber; high-modulus polyethylene (HMPE); high-performance polyethylene (HPPE); medical; surgical implants; ultra-high molecular weight polyethylene (UHMW-PE, UHMWPE); yarn;

ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials); 83.080.20 (Thermoplastic materials)

Citing ASTM Standards

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