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ASTM F2083-10
Standard Specification for Total Knee Prosthesis
Automaticky přeložený název:
Standardní specifikace pro Total kolenního kloubu
NORMA vydána dne 15.4.2010
Informace o normě:
Označení normy: ASTM F2083-10
Poznámka: NEPLATNÁ
Datum vydání normy: 15.4.2010
Kód zboží: NS-52734
Počet stran: 9
Přibližná hmotnost: 27 g (0.06 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F2083-10 :
Keywords:
arthroplasty, contact area, contact pressure, fatigue, knee, knee constraint, knee prosthesis, knee wear, particles, surface roughness, total knee replacement, TKR, UHMWPE, Knee replacement prosthesis--specifications, Medical materials/applications--specifications, Orthopaedic medical devices--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Doplňující informace
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110° of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F1672. 1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs. 1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself define a device that will provide adequate clinical performance. 1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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