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定价： 798元

1 Scope 1.1 This International Standard specifies tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve substitutes of all types, and of the materials and

定价： 1001元 / 折扣价： 851 元

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This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. 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. Acetabular prostheses shall be classified as: Type I and Type II. The following test methods shall be performed: mechanical strength; corrosion resistance; biocompatibility; structural requirements; metal and ceramic coating or surface texture integrity; component disassociation; fixation failure; device fracture; and articular surface wear.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.

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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.

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