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ASTM F1378-04

(Specification)

Standard Specification for Shoulder Prosthesis

Standard Specification for Shoulder Prosthesis

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
29-Feb-2004
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 F1378-00 - Standard Specification for Shoulder Prosthesis
Effective Date
01-Mar-2004
Replaced By
ASTM F1378-05 - Standard Specification for Shoulder Prosthesis
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-Mar-2004
Referred By
ASTM F2028-17 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
Effective Date
01-Mar-2004

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ASTM F1378-04 - Standard Specification for Shoulder Prosthesis
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1378 – 04
Standard Specification for
1
Shoulder Prostheses
This standard is issued under the fixed designation F 1378; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 648 Specification for Ultra-High-Molecular-Weight Poly-
ethylene Powder and Fabricated Form for Surgical Im-
1.1 Thisspecificationcoversshoulderprosthesesfortotalor
plants
hemiarthroplasty used to provide functioning articulation by
F 745 Specification for 18Chromium-12.5Nickel-
employing glenoid and humeral components.
2.5Molybdenum Stainless Steel for Cast and Solution-
1.2 Devices for custom applications are not covered by this
Annealed Surgical Implant Applications
specification. Modular prostheses are included in this specifi-
F 746 Test Method for Pitting or Crevice Corrosion of
cation.
Metallic Surgical Implant Materials
1.3 The values stated in SI are to be regarded as the
F 748 Practice for Selecting Generic Biological Test Meth-
standard. The inch-pound units given in parentheses are for
ods for Materials and Devices
information only.
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
2. Referenced Documents Alloy Forgings for Surgical Implants (UNS R31537,
2
R31538, R31539)
2.1 ASTM Standards:
F 981 Practice for Assessment of Compatibility of Bio-
F 75 Specification for Cobalt-28Chromium-6Molybdenum
Materials (Non-Porous) for Surgical Implants with Respect
Alloy Castings and Casting Alloy for Surgical Implants
to Effect of Materials on Muscle and Bone
(UNS R30075)
F 983 Practice for Permanent Marking of Orthopaedic Im-
F 86 Practice for Surface Preparation and Marking of Me-
plant Components
tallic Surgical Implants
F 1044 Test Method for Shear Testing of Calcium Phos-
F 90 Specification for Wrought Cobalt-20Chromium-
phate Coatings and Metallic Coatings
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
F 1108 Specification for Titanium-6Aluminum-4Vanadium
tions (UNS R30605)
Alloy Castings for Surgical Implants (UNS R56406)
F 136 Specification for Wrought Titanium-6Aluminum-
F 1147 Test Method for Tension Testing of Calcium Phos-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
phate and Metal Coatings
Implant Applications (UNS R56401)
F 1537 Specification for Wrought Cobalt-28Chromium-
F 138 Specification for Wrought 18Chromium-14Nickel-
6Molybdenum Alloy for Surgical Implants (UNS R31537,
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
UNS R31538, and UNS R31539)
Implants (UNS S31673)
F 1829 Test Method for Static Evaluation of the Glenoid
F 562 Specification for Wrought 35Cobalt-35Nickel-
Locking Mechanism in Shear
2Chromium-10Molybdenum Alloy for Surgical Implant
F 2028 Test Methods for the Dynamic Evaluation of Gle-
Applications (UNS R30035)
noid Loosening or Dissociation
F 563 Specification for Wrought Cobalt-20Nickel-
3
2.2 ANSI Standard:
20Chromium-3.5 Molybdenum-3.5Tungsten-5Iron Alloy
ASME B46.1–1995
for Surgical Implant Applications (UNS R30563)
F 603 Specification for High-Purity Dense Aluminum Ox-
3. Terminology
ide for Surgical Implant Applications
3.1 Definitions of Terms Specific to This Standard:
3.1.1 collar—flange at junction of neck and stem.
3.1.2 glenoid component—the prosthetic portion that re-
1
This specification is under the jurisdiction of ASTM Committee F04 on
places, in part or in total, the glenoid fossa of the scapula and
Medical and Surgical Materials and Devices and is the direct responsibility of
articulates with the natural humeral head or a prosthetic
Subcommittee F04.22 on Arthroplasty.
Current edition approved Mar. 1, 2004. Published March 2004. Originally replacement.
approved in 1992. Last previous edition approved in 2000 as F 1378 – 00.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
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 ----------------------
F1378–04
3.1.3 head—bearing member for articulation with the gle- 6. Performance Requirements
noid.
6.1 Wear of Alternative Materials—It is important to under-
3.1.4 humeral component—the prosthetic portion that re-
stand the wear performance for articulating surfaces.Any new
places,inpartorintoto,theproximalhumerusorhumeralhead
or different material should not exceed the wear rates of the
and artic
...

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1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
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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.  
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Standard Guide for Total Knee Replacement Loading Profiles

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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
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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1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off