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ASTM F1378-05

(Specification)

Standard Specification for Shoulder Prosthesis

Standard Specification for Shoulder Prosthesis

ABSTRACT
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.
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 are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

General Information

Status
Historical
Publication Date
30-Sep-2005
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F1378-04 - Standard Specification for Shoulder Prosthesis
Effective Date
01-Oct-2005
Replaced By
ASTM F1378-05(2010) - Standard Specification for Shoulder Prosthesis
Effective Date
15-Dec-2010
Referred By
ASTM F2028-17 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
Effective Date
01-Oct-2005
Referred By
ASTM F1829-23 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Effective Date
01-Oct-2005

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ASTM F1378-05 - Standard Specification for Shoulder Prosthesis
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation: F1378 – 05
Standard Specification for
1
Shoulder Prostheses
This standard is issued under the fixed designation F1378; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F563 Specification for Wrought Cobalt-20Nickel-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.1 This specification covers shoulder prostheses for total or
3
for Surgical Implant Applications (UNS R30563)
hemiarthroplasty used to provide functioning articulation by
F603 Specification for High-Purity DenseAluminum Oxide
employing glenoid and humeral components.
3
for Medical Application
1.2 Devices for custom applications are not covered by this
F648 Specification for Ultra-High-Molecular-Weight Poly-
specification. Modular prostheses are included in this specifi-
ethylene Powder and Fabricated Form for Surgical Im-
cation.
plants
1.3 The values stated in SI are to be regarded as the
F745 Specification for 18Chromium-12.5Nickel-
standard. The inch-pound units given in parentheses are for
2.5Molybdenum Stainless Steel for Cast and Solution-
information only.
Annealed Surgical Implant Applications
2. Referenced Documents F746 Test Method for Pitting or Crevice Corrosion of
2
Metallic Surgical Implant Materials
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Meth-
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
ods for Materials and Devices
Alloy Castings and Casting Alloy for Surgical Implants
F799 Specification for Cobalt-28Chromium-6Molybdenum
(UNS R30075)
Alloy Forgings for Surgical Implants (UNS R31537,
F86 Practice for Surface Preparation and Marking of Me-
R31538, R31539)
tallic Surgical Implants
F981 Practice forAssessment of Compatibility of Biomate-
F90 Specification for Wrought Cobalt-20Chromium-
rials for Surgical Implants with Respect to Effect of
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
Materials on Muscle and Bone
tions (UNS R30605)
F983 Practice for Permanent Marking of Orthopaedic Im-
F136 Specification for Wrought Titanium-6Aluminum-
plant Components
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
F1044 Test Method for ShearTesting of Calcium Phosphate
Implant Applications (UNS R56401)
Coatings and Metallic Coatings
F138 Specification for Wrought 18Chromium-14Nickel-
F1108 Specification for Titanium-6Aluminum-4Vanadium
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Alloy Castings for Surgical Implants (UNS R56406)
Implants (UNS S31673)
F1147 Test Method for Tension Testing of Calcium Phos-
F562 Specification for Wrought 35Cobalt-35Nickel-
phate and Metallic Coatings
20Chromium-10Molybdenum Alloy for Surgical Implant
F1537 Specification for Wrought Cobalt-28Chromium-
Applications (UNS R30035)
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
UNS R31538, and UNS R31539)
F1829 Test Method for Static Evaluation of Glenoid Lock-
ing Mechanism in Shear
F2028 Test Methods for Dynamic Evaluation of Glenoid
1 Loosening or Disassociation
This specification is under the jurisdiction of ASTM Committee F04 on
4
2.2 ANSI Standard:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
ASME B46.1–1995
Current edition approved Oct. 1, 2005. Published October 2005. Originally
approved in 1992. Last previous edition approved in 2004 as F1378 – 04. DOI:
10.1520/F1378-05.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Withdrawn. The last approved version of this historical standard is referenced
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM on www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
F1378 – 05
3. Terminology 5.1.3 Biocompatibility—Materials with limited or no his-
tory of successful use for orthopedic implant application must
3.1 Definitions of Terms Specific to This Standard:
be determined to exhibit acceptable biological response equal
3.1.1 collar—flange at junction of neck and stem.
to or better than one of the materials listed in 5.1.1 when tested
3.1.2 glenoid component—the prosthetic portion that re-
in accordance with Practi
...

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4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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A1.1 Significance and Use
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1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off