【国外标准】 Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)

This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads. Femoral prostheses presented are defined as follows: type IA - single-piece (mono-block), metallic femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem, neck and head, type IB - single-piece (mono-block), metallic, femoral total hip or hemi- arthroplasty hip prostheses with an integral stem, neck, and head, type IIA - modular metallic femoral hip prostheses that could include a modular (type II) head or other modular components, or both, and type IIB - Modular metallic femoral hip prosthesis that could include a modular (type II) head or other modular components, or both. Femoral prostheses shall be capable of withstanding normal static and dynamic loading in the physiological range without overload fracture, plastic deformation, or fatigue fracture. Shear strength, tensile strength, and abrasion resistance of plasma spray thermal coatings shall be tested to meet the requirements prescribed.1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.1.3 Femoral 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, or through the ingrowth of host bone into a porous coating.1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.