ASTM F1357-23
Standard Specification for Articulating Total Wrist Implants

Standard No.

ASTM F1357-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F1357-23

Scope

1.1 This specification describes total wrist implants used to provide functioning articulation by employing radial and carpal components. 1.2 This specification excludes those implants with ceramiccoated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and those devices used for custom applications. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 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.

ASTM F1357-23 Referenced Document

• ANSI/ASME B46.1 Surface Texture, Surface Roughness, Waviness and Lay*， 2024-04-21 Update
• ASTM F1108 Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
• ASTM F1223 Standard Test Method for Determination of Total Knee Replacement Constraint
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM F2003 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
• ASTM F2129 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
• ASTM F3306 Standard Test Method for Ion Release Evaluation of Medical Implants
• ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
• ASTM F601 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• ASTM F629 Standard Practice for Radiography of Cast Metallic Surgical Implants
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• ISO 5832-3 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• ISO 5832-4 Implants for surgery*， 2024-03-01 Update
• ISO 5832-5 Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel
• ISO 5834-2 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

ASTM F1357-23 history

• 2023 ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
• 2019 ASTM F1357-14(2019) Standard Specification for Articulating Total Wrist Implants
• 2014 ASTM F1357-14 Standard Specification for Articulating Total Wrist Implants
• 2009 ASTM F1357-09 Standard Specification for Articulating Total Wrist Implants
• 1999 ASTM F1357-99(2009) Standard Specification for Articulating Total Wrist Implants
• 1999 ASTM F1357-99(2004) Standard Specification for Articulating Total Wrist Implants
• 1999 ASTM F1357-99 Standard Specification for Articulating Total Wrist Implants