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  • ASTM
    F2848-16 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
    Edition: 2016
    $103.58
    Unlimited Users per year

Description of ASTM-F2848 2016

ASTM F2848-16

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


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/F2848-16

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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