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ASTM F2565-21
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
NORMA vydaná dňa 15.5.2021
Informácie o norme:
Označenie normy: ASTM F2565-21
Dátum vydania normy: 15.5.2021
Kód tovaru: NS-1025345
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Kategórie - podobné normy:
Anotácia textu normy ASTM F2565-21 :
This guide covers extensively irradiation-crosslinked ultra-high molecular weight polyethylene (UHMWPE) fabricated forms for surgical implant applications. Only gamma and electron beam irradiated extensively crosslinked materials are covered by this guide. Chemical composition and physical properties of extensively crosslinked UHMWPE fabricated form shall conform to the requirements of this guide which include ultimate tensile strength, yield strength, elongation, Izod impact strength, ultimate load, fatigue crack propagation, compressive modulus, percent crystallinity, melting temperature, residual free radicals, swell ratio, oxidation index, and t-vinylene content. Biocompatibility of the material shall also be considered when new applications of the material, or modification to the material or physical forms of the materials are being contemplated.
Keywords:
fabricated forms, powdered form, ultra-high molecular weight polyethylene,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics),83.080.10 (Thermosetting materials)
Doplňujúce informácie
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||
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1.1?This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648. 1.2?This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods. 1.3?This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. 1.4?The specific relationships between these mechanical properties and the 1.5?The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: 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. 1.6?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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