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ASTM F2665-21
Standard Specification for Total Ankle Replacement Prosthesis
NORMA vydaná dňa 1.4.2021
Informácie o norme:
Označenie normy: ASTM F2665-21
Dátum vydania normy: 1.4.2021
Kód tovaru: NS-1021946
Počet strán: 8
Približná hmotnosť: 24 g (0.05 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Kategórie - podobné normy:
Anotácia textu normy ASTM F2665-21 :
Keywords:
ankle, ankle constraint, ankle prosthesis, ankle wear, arthroplasty, contact area, contact pressure, fatigue, particles, surface roughness, total ankle replacement (TAR), UHMWPE,, ICS Number Code 11.180.10 (Aids and adaptations for moving)
Doplňujúce informácie
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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1.1?This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15? of dorsiflexion and 15 to 25? 1.2?Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use. 1.3?This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in-vivo performance of the prosthesis are defined. 1.4?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5?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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