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Standard Specification for Acetabular Prostheses
Automatische name übersetzung:
Standard-Spezifikation für Hüftgelenkprothesen
NORM herausgegeben am 15.1.2012
Bezeichnung normen: ASTM F2091-01(2012)
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 15.1.2012
SKU: NS-52778
Zahl der Seiten: 6
Gewicht ca.: 18 g (0.04 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Keywords:
acetabulum, arthroplasty, prosthesis, Orthopaedic medical devices--specifications, Surgical implants--specifications, Acetabular implant device, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. 1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined. 1.3 Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation. 1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification. 1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001. |
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2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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