ASTM-F2848 2021(Redline)

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F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns (Redline)

Published By	Publication Date	Number of Pages
ASTM	2021

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Categories: 11.040.30 - Surgical instruments and materials, ASTM

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Description

ASTM F2848-21

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

ASTM F2848

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. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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)

DOI: 10.1520/F2848-21

Additional information

Standard Title	F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns (Redline)
Published Code	ASTM
Publication Date	2021
ICS Codes	11.040.30 - Surgical instruments and materials