Over deze norm
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 fixation by press-fit between the prosthesis and host bone, the use of bone cement, the use of bone screws or similar means of mechanical fixation, or through biological fixation of host bone and/or soft connective tissue into a porous surface.
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.
|Engelse titel||Standard Specification for Acetabular Prostheses|