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ASTM F2887-23

Standard Specification for Total Elbow Prostheses

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NORM herausgegeben am 1.3.2023

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Informationen über die Norm:

Bezeichnung normen: ASTM F2887-23
Ausgabedatum normen: 1.3.2023
SKU: NS-1136878
Zahl der Seiten: 9
Gewicht ca.: 27 g (0.06 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM

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Kategorie - ähnliche Normen:

Aids and adaptation for moving

Die Annotation des Normtextes ASTM F2887-23 :

Keywords:

arthroplasty, disassembly, elbow, elbow constraint, elbow prosthesis, elbow wear, hemi-elbow replacement, linked semi-constrained, stem fatigue, surface roughness, TER, total elbow replacement, UHMWPE particles, unlinked,, ICS Number Code 11.180.10 (Aids and adaptations for moving)

Ergänzende Informationen

1. Scope

1.1?This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (hemi) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.

1.2?Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.

1.3?This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device will provide satisfactory clinical performance.

1.4?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

F732-17	Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F746-04(2021)	Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799-19	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F983-86(2018)	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F1044-05(2017)e1	Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).
F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147-05(2017)e1	Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).
F1160-14(2017)e1	Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings (Includes all amendments and changes 1/19/2018).
F1223-20	Standard Test Method for Determination of Total Knee Replacement Constraint
F1377-21	Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
F1472-23	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ISO 14243–1	Implants for Surgery--Wear of Total Knee-Joint Prostheses--Part 1: Loading and Displacement Parameters for Wear-testing Machines with Load Control and Corresponding Environmental Conditions for Test
ISO 14243–2	Implants for Surgery--Wear of Total Knee-joint Prostheses--Part 2: Methods of Measurement
ISO 14243–3	Implants for Surgery--Wear of Total Knee-joint Prostheses--Part 3: Loading and Displacement Parameters for Wear-testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F565-21	Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F451-21	Standard Specification for Acrylic Bone Cement
F136-13(2021)e1	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).
F90-23	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F2759-19	Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
F1814-22	Standard Guide for Evaluating Modular Hip and Knee Joint Components
F1580-18	Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
ISO 10993	Biological Evaluation of Medical Devices--Part I: Evaluation and Testing Within a Risk Management Process
ISO 6018	Orthopaedic Implants--General Requirements for Marking, Packaging, and Labeling
ISO 5834–2	Implants for Surgery--Ultra High Molecular Weight Polyethylene--Part 2: Moulded Forms
ISO 5832–12	Implants for Surgery--Metallic Materials--Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
ISO 5832–3	Implants for Surgery--Metallic Materials--Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy
ISO 5832–4	Implants for Surgery--Metallic Materials--Part 4: Cobalt-Chromium-Molybdenum Casting Alloy

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