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ASTM F2091-01(2012)
Standard Specification for Acetabular Prostheses
Automaticky přeložený název:
Standard Specification pro acetabula Protézy
NORMA vydána dne 15.1.2012
Informace o normě:
Označení normy: ASTM F2091-01(2012)
Poznámka: NEPLATNÁ
Datum vydání normy: 15.1.2012
Kód zboží: NS-52778
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F2091-01(2012) :
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)
Doplňující informace
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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