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ASTM F1378-12

(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.

General Information

Status
Historical
Publication Date
31-Dec-2011
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 F1378-05(2010) - Standard Specification for Shoulder Prosthesis
Effective Date
01-Jan-2012
Replaced By
ASTM F1378-17 - Standard Specification for Shoulder Prostheses
Effective Date
01-Dec-2017
Referred By
ASTM F1829-23 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Effective Date
01-Jan-2012
Referred By
ASTM F2028-17 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
Effective Date
01-Jan-2012

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1378 −12
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 for Surgical Implant Applications (UNS R30563) (With-
3
drawn 2005)
1.1 This specification covers shoulder prostheses for total or
F603 Specification for High-Purity Dense Aluminum Oxide
hemiarthroplasty used to provide functioning articulation by
for Medical Application
employing glenoid and humeral components.
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.2 Devices for custom applications are not covered by this
ethylene Powder and Fabricated Form for Surgical Im-
specification. Modular prostheses are included in this specifi-
plants
cation.
F745 Specification for 18Chromium-12.5Nickel-
2.5Molybdenum Stainless Steel for Cast and Solution-
1.3 The values stated in SI units are to be regarded as
Annealed Surgical Implant Applications (Withdrawn
standard. No other units of measurement are included in this
3
2012)
standard.
F746 Test Method for Pitting or Crevice Corrosion of
Metallic Surgical Implant Materials
2. Referenced Documents
F748 PracticeforSelectingGenericBiologicalTestMethods
2
2.1 ASTM Standards:
for Materials and Devices
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F799 Specification for Cobalt-28Chromium-6Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
Alloy Forgings for Surgical Implants (UNS R31537,
(UNS R30075)
R31538, R31539)
F86 Practice for Surface Preparation and Marking of Metal-
F981 Practice for Assessment of Compatibility of Biomate-
lic Surgical Implants
rials for Surgical Implants with Respect to Effect of
F90 Specification for Wrought Cobalt-20Chromium-
Materials on Muscle and Bone
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
F983 Practice for Permanent Marking of Orthopaedic Im-
tions (UNS R30605)
plant Components
F136 Specification for Wrought Titanium-6Aluminum-
F1044 Test Method for Shear Testing of Calcium Phosphate
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
Coatings and Metallic Coatings
Implant Applications (UNS R56401)
F1108 Specification for Titanium-6Aluminum-4Vanadium
F138 Specification for Wrought 18Chromium-14Nickel-
Alloy Castings for Surgical Implants (UNS R56406)
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
F1147 Test Method for Tension Testing of Calcium Phos-
Implants (UNS S31673)
phate and Metallic Coatings
F562 Specification for Wrought 35Cobalt-35Nickel-
F1537 Specification for Wrought Cobalt-28Chromium-
20Chromium-10Molybdenum Alloy for Surgical Implant
6Molybdenum Alloys for Surgical Implants (UNS
Applications (UNS R30035)
R31537, UNS R31538, and UNS R31539)
F563 Specification for Wrought Cobalt-20Nickel-
F1829 Test Method for Static Evaluation of Glenoid Lock-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
ing Mechanism in Shear
F2028 Test Methods for Dynamic Evaluation of Glenoid
Loosening or Disassociation
1
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
ASME B46.1–1995
Subcommittee F04.22 on Arthroplasty.
Current edition approved Jan. 1, 2012. Published January 2012. Originally
approved in 1992. Last previous edition approved in 2010 as F1378 – 05 (2010).
DOI: 10.1520/F1378-12.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 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 ----------------------
F1378−12
3. Terminology better than one of the materials listed in 5.1.1 when tested in
accordance with Test Method F746.
3.1 Definitions of Terms Specific to This Standard:
5.1.3 Biocompatibility—Materials with limited or no history
3.1.1 collar—flange at the junction of the neck and stem.
of successful use for orthopedic implant application must be
3.1.2 glenoid component—the prosthetic portion that
determined to exhibit acceptable biological response equal to
replaces, in part or in total, the glenoid fossa of the scapula and
or better than one of the materials listed in 5.1.1 when tested in
articulates
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F1378–05 (Reapproved 2010) Designation: F1378 – 12
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
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.
1.3ThevaluesstatedinSIaretoberegardedasthestandard.Theinch-poundunitsgiveninparenthesesareforinformationonly.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloy for Surgical Implant
Applications (UNS R30563)
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
Implant Applications
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Dec. 15, 2010. Published February 2011. Originally approved in 1992. Last previous edition approved in 2005 as F1378–05. DOI:
10.1520/F1378-05R10.
Current edition approved Jan. 1, 2012. Published January 2012. Originally approved in 1992. Last previous edition approved in 2010 as F1378 – 05 (2010). DOI:
10.1520/F1378-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F1378 – 12
F1829 Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear
F2028 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
3
2.2 ANSI Standard:
ASME B46.1–1995
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 collar—flange at the junction of the neck and stem.
3.1.2 glenoid component—the prosthetic portion that replaces, in part or in total, the glenoid fossa of the scapula and articulates
wi
...

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ASTM
ASTM F3141-23(Guide)
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.
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).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
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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  • Guide
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ASTM
ASTM F3047M-23(Guide)
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.

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