ASTM F1378-18e1

Standard Specification for Shoulder Prostheses (Includes all amendments and changes 6/14/2019).

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STANDARD published on 15.12.2018

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The information about the standard:

Designation standards: ASTM F1378-18e1
Publication date standards: 15.12.2018
SKU: NS-951574
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F1378-18e1 :

This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this specification, but devices for custom applications are not covered. The prostheses are required to meet the prescribed mechanical strength, corrosion resistance, biocompatibility, wear of alternative, and range of motion.

Keywords:
arthroplasty, glenoid, humeral, prostheses, hemi-shoulder replacement, total shoulder replacement,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components.

1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.

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

FIG. 1 Glenosphere Thickness

1.4 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

F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F983-86(2018)	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F2028-17	Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
	ASME B46.1-1995
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F745-07	Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
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)
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90-23	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
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).
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F562-22	Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F563-00	Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
F603-12(2020)	Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F1147-05(2017)e1	Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).
F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
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).
F1829-23	Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

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