ASTM F2848 - 17 - Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

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ASTM F2848 - 17

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

Status : Current   Published : May 2017

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PDF

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HARDCOPY



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.

TABLE 1 Requirements for UHMWPE Yarns

[This table has been removed.]

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.




Standard NumberASTM F2848 - 17
TitleStandard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
StatusCurrent
Publication Date01 May 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Fiber High-modulus polyethylene (HMPE) High-performance polyethylene (HPPE) Medical Surgical implants Ultra-high molecular weight polyethylene (UHMW-PE, UHMWPE) Yarn
ICS11.040.30
PublisherASTM
FormatA4
DeliveryYes
Pages5
File Size93 KB
Price£40.00


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