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ASTM F 2848 : 2017

Current
Current

The latest, up-to-date edition.

Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-07-2017

Publisher

American Society for Testing and Materials

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.

1.1This 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.

1.2This 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.

1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4This 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

Property

Test Method

Requirement

Density, g/cm3

Test Methods D792 or D1505

0.95 - 1.00

Melting temperature – peak, °C

Test Method F2625

140 - 150

Filament Linear Density, dtex (Maximum)

6.3

2.7

Intrinsic Viscosity, dl/g (Minimum)

6.4

15

Tensile Strength, cN/dtex (Minimum)

6.5

26

Tensile Modulus, cN/dtex (Minimum)

6.5

750

Elongation-at-break, %

6.5

2 - 5

Additional requirement for colored yarn:

 Pigment content, wt.% (Maximum)
 Chromium-cobalt-aluminum oxide

6.2

2

1.5This 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.

Committee
F 04
DocumentType
Standard
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current
SupersededBy
Supersedes

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

ASTM F 2625 : 2007 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
ASTM D 1601 : 1999 Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers
ASTM D 1505 : 2003 Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM F 2625 : 2010 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
ASTM D 1601 : 2018 Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers
ASTM D 1505 : 1968 : R1979 Standard Test Method for Density Of Plastics By The Density-Gradient Technique
ASTM D 1601 : 1978 Standard Test Method for Dilute Solution Viscosity Of Ethylene Polymers
ASTM D 1505 : 2010 Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 1505 : 2018 Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 1505 : 1998 : EDT 1 Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 1601 : 2012 Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers
ASTM F 2625 : 2010 : R2016 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry

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