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Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
Přeložit název
NORMA vydána dne 1.6.2021
Označení normy: ASTM F2848-21
Datum vydání normy: 1.6.2021
Kód zboží: NS-1027399
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
fiber, high-modulus polyethylene (HMPE), high-performance polyethylene (HPPE), medical, surgical implants, ultra-high-molecular-weight polyethylene (UHMW-PE, UHMWPE), yarn,, ICS Number Code 11.040.30 (Surgical instruments and materials),83.080.20 (Thermoplastic materials)
1. 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. |
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2. Referenced Documents | ||||||||||||||||||
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