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ASTM F 2091 : 2015 : REDLINE

Current

Current

The latest, up-to-date edition.

Standard Specification for Acetabular Prostheses

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Language(s)

English

Published date

15-03-2015

€67.30
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CONTAINED IN VOL. 13.01, 2015 Defines acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.

Committee
F 04
DocumentType
Redline
Pages
7
PublisherName
American Society for Testing and Materials
Status
Current

1.1This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.

1.2This 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.

1.3Acetabular 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.

1.4Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification.

1.5This 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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ASTM F 1820 : 2013 : REDLINE Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ASTM F 1108 : 2014 : REDLINE Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
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ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 9001:2015 Quality management systems — Requirements
ASTM F 1537 : 2011 : REDLINE Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM F 2033 : 2012 : REDLINE Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
ASTM F 799 : 2011 : REDLINE SPECIFICATION FOR COBALT-28CHROMIUM-6MOLYBDENUM ALLOY FORGINGS FOR SURGICAL IMPLANTS (UNS R31537, R31538, R31539)
ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ISO 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
ASTM F 2582 : 2014 : REDLINE Standard Test Method for Impingement of Acetabular Prostheses

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