ASTM F1357-14(2019)

Standard Specification for Articulating Total Wrist Implants

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STANDARD published on 15.11.2019

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The information about the standard:

Designation standards: ASTM F1357-14(2019)
Note: WITHDRAWN
Publication date standards: 15.11.2019
SKU: NS-979022
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F1357-14(2019) :

Keywords:
arthroplasty, prosthesis, total wrist replacement,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial and carpal components.

1.2 This specification excludes those implants with ceramic-coated 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.

2. Referenced Documents

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)
F629-20	Standard Practice for Radiography of Cast Metallic Surgical Implants
F983-86(2018)	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
ANSI/ASME B46.1	Surface Texture (Surface Roughness, Waviness, and Lay) Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F562-22	Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F563-00	Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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)
F603-12(2020)	Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

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