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ASTM F1378-18e1

(Specification)

Standard Specification for Shoulder Prostheses

Standard Specification for Shoulder Prostheses

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 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.

General Information

Status
Published
Publication Date
14-Dec-2018
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 F1378-18 - Standard Specification for Shoulder Prostheses
Effective Date
15-Dec-2018
Refers
ASTM F1829-16 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Effective Date
01-Mar-2016
Refers
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Apr-2016
Refers
ASTM F2028-17 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
Effective Date
01-Dec-2017
Refers
ASTM F1044-05(2017)e1 - Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Effective Date
01-Dec-2017
Refers
ASTM F983-86(2018) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
Effective Date
01-Feb-2018
Refers
ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
15-May-2019
Refers
ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Effective Date
01-Dec-2019
Refers
ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
01-Mar-2020
Refers
ASTM F603-12(2020) - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Effective Date
01-Aug-2020
Refers
ASTM F603-12(2016) - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Effective Date
01-Oct-2016
Referred By
ASTM F1829-23 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Effective Date
15-Dec-2018

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ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
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Standards Content (Sample)

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.
´1
Designation: F1378 −18
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
ε NOTE—Corrected editorially in June 2019.
1. Scope 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Implants (UNS S31673)
1.1 This specification covers shoulder prostheses for total or
F562 Specification for Wrought 35Cobalt-35Nickel-
hemiarthroplasty used to provide functioning articulation by
20Chromium-10Molybdenum Alloy for Surgical Implant
employing glenoid and humeral components.
Applications (UNS R30035)
1.2 Devices for custom applications are not covered by this
F563 Specification for Wrought Cobalt-20Nickel-
specification. Modular prostheses are included in this specifi-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
cation.
for Surgical Implant Applications (UNS R30563) (With-
3
1.3 The values stated in SI units are to be regarded as drawn 2005)
F603 Specification for High-Purity Dense Aluminum Oxide
standard. No other units of measurement are included in this
standard. for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.4 This international standard was developed in accor-
ethylene Powder and Fabricated Form for Surgical Im-
dance with internationally recognized principles on standard-
plants
ization established in the Decision on Principles for the
F745 Specification for 18Chromium-12.5Nickel-
Development of International Standards, Guides and Recom-
2.5Molybdenum Stainless Steel for Cast and Solution-
mendations issued by the World Trade Organization Technical
Annealed Surgical Implant Applications (Withdrawn
Barriers to Trade (TBT) Committee.
3
2012)
F746 Test Method for Pitting or Crevice Corrosion of
2. Referenced Documents
Metallic Surgical Implant Materials
2
2.1 ASTM Standards:
F748 PracticeforSelectingGenericBiologicalTestMethods
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
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 Metal-
R31538, R31539)
lic Surgical Implants
F981 Practice for Assessment of Compatibility of Biomate-
F90 Specification for Wrought Cobalt-20Chromium-
rials for Surgical Implants with Respect to Effect of
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
Materials on Muscle and Insertion into 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 Shear Testing of Calcium Phosphate
Implant Applications (UNS R56401)
Coatings and Metallic Coatings
F138 Specification for Wrought 18Chromium-14Nickel-
F1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings for Surgical Implants (UNS R56406)
F1147 Test Method for Tension Testing of Calcium Phos-
1
This specification is under the jurisdiction of ASTM Committee F04 on
phate and Metallic Coatings
Medical and Surgical Materials and Devices and is the direct responsibility of
F1537 Specification for Wrought Cobalt-28Chromium-
Subcommittee F04.22 on Arthroplasty.
Current edition approved Dec. 15, 2018. Published March 2019. Originally
6Molybdenum Alloys for Surgical Implants (UNS
approved in 1992. Last previous edition approved in 2017 as F1378 – 17. DOI:
R31537, UNS R31538, and UNS R31539)
10.1520/F1378-18E01.
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 The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
F1378 − 18
FIG. 1 Glenosphere Thickness
F1820 Test Method for Determining the Forces for Disas- 3.2.2 reverse glenoid component, n—the convex prosthetic
sembly of Modular Acetabular Devices portion that replaces the glenoid fossa of the scapula and
F1829 Test Method for Static Evaluation of Anatomic Gle- articulates with a concave prosthetic replacement of the hu-
noi
...

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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

SIGNIFICANCE AND USE
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.
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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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
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