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Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
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
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) | 6.2 | 2 |
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 StandardDetails, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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