1.1 This guide covers general test methods for the chemical, biocompatibility, mechanical, and preclinical assessments of implantable devices with metal-on-metal or ceramics-on-ceramics articulation intended to replace a hip joint. This guide covers only total hip arthroplasty devices with stems that extend or fix within the intermedullarycanal. Such devices shall have articulating components manufactured from cobalt-28 % chromium-6 % molybdenum (Co28Cr6Mo) alloy (Specifications F75, F799, or F1537) or high-purity alumina (ISO 6474-1) or alumina matrix composite ceramics (ISO 6474-2). This guide does not address devices manufactured from any other material. 1.2 This guide will emphasize the acetabular component and the articulating surface of both the acetabular component and the head. Acetabular components can be one single component or a modular component with a separate acetabular shell and acetabular liner. In the case of modular acetabular components, the acetabular liner will always be Co28Cr6Mo for a metal-on-metal bearing and high-purity alumina or alumina matrix composite ceramics for a ceramic-on-ceramic bearing. Modular acetabular shells shall be limited to Ti-6Al-4V (Specification F136)or Co28Cr6Mo. Acetabular components may have external coatings intended for attachment to bone cement or tissue. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsmusculoskeletal joint replacement; orthopedic device; metal-on-metal hip prosthesis; ceramic-on-ceramic hip prosthesis; metal-on-metal total hip arthroplasty; ceramic-on-ceramic total hip arthroplasty; modular acetabular system; cobalt-28 % chromium-6 % molybdenum alloy; Co28Cr6Mo; Ti-6Al-4V alloy; high-purity alumina; high-purity alumina matrix composite
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