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ASTM F2887-17

(Specification)

Standard Specification for Total Elbow Prostheses

Standard Specification for Total Elbow Prostheses

SCOPE
1.1 This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.  
1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.  
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device will provide satisfactory clinical performance.  
1.4 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-2016
ICS
11.180.10 - Aids and adaptation for moving
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F2887 − 17
Standard Specification for
1
Total Elbow Prostheses
This standard is issued under the fixed designation F2887; 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 F451 Specification for Acrylic Bone Cement
F565 Practice for Care and Handling of Orthopedic Implants
1.1 This specification covers total elbow replacement (TER)
and Instruments
prostheses and hemi-elbow replacement (“hemi”) prostheses
F648 Specification for Ultra-High-Molecular-Weight Poly-
used to provide functioning articulation by employing humeral,
ethylene Powder and Fabricated Form for Surgical Im-
ulnar, and/or radial components that allow for the restoration of
plants
motion of the human elbow joint complex.
F732 Test Method for Wear Testing of Polymeric Materials
1.2 Included within the scope of this specification are elbow
Used in Total Joint Prostheses
prosthesis components for primary and revision surgery with
F746 Test Method for Pitting or Crevice Corrosion of
linked and non-linked designs and components implanted with
Metallic Surgical Implant Materials
or without use of bone cement.
F748 Practice for Selecting Generic Biological Test Methods
1.3 This specification is intended to provide basic descrip-
for Materials and Devices
tions of material and prosthesis geometry. In addition, those
F799 Specification for Cobalt-28Chromium-6Molybdenum
characteristics determined to be important to the in vivo
Alloy Forgings for Surgical Implants (UNS R31537,
performance of the prosthesis are defined. However, compli-
R31538, R31539)
ance with this specification does not itself mean that a device
F983 Practice for Permanent Marking of Orthopaedic Im-
will provide satisfactory clinical performance.
plant Components
1.4 The values stated in SI units are to be regarded as
F1044 Test Method for Shear Testing of Calcium Phosphate
standard. No other units of measurement are included in this
Coatings and Metallic Coatings
standard.
F1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings for Surgical Implants (UNS R56406)
2. Referenced Documents
F1147 Test Method for Tension Testing of Calcium Phos-
2
2.1 ASTM Standards:
phate and Metallic Coatings
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F1160 Test Method for Shear and Bending Fatigue Testing
Alloy Castings and Casting Alloy for Surgical Implants
of Calcium Phosphate and Metallic Medical and Compos-
(UNS R30075)
ite Calcium Phosphate/Metallic Coatings
F86 Practice for Surface Preparation and Marking of Metal-
F1223 Test Method for Determination of Total Knee Re-
lic Surgical Implants
placement Constraint
F90 Specification for Wrought Cobalt-20Chromium-
F1377 Specification for Cobalt-28Chromium-6Molybdenum
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
Powder for Coating of Orthopedic Implants (UNS
tions (UNS R30605)
R30075)
F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical F1472 Specification for Wrought Titanium-6Aluminum-
Implant Applications (UNS R56401) 4Vanadium Alloy for Surgical Implant Applications (UNS
R56400)
1 F1537 Specification for Wrought Cobalt-28Chromium-
This test method is under the jurisdiction of ASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee 6Molybdenum Alloys for Surgical Implants (UNS
F04.22 on Arthroplasty.
R31537, UNS R31538, and UNS R31539)
Current edition approved Jan. 1, 2017. Published March 2017. Originally
F1580 Specification for Titanium and Titanium-6
approved in 2012. Last previous edition approved in 2012 as F2887-12. DOI:
10.1520/F2887–17. Aluminum-4 Vanadium Alloy Powders for Coatings of
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Implants
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F1814 Guide for Evaluating Modular Hip and Knee Joint
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Components
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2887 − 17
F2759 Guide for Assessment of the Ultra High Molecular 3. Terminology
Weight Polyethylene (UHMWPE) Used in Orthopedic and
3.1 Definitions of Terms Specific to This Standard:
Spinal Devices
3.1.1 bearing surface, n—part of the prosthetic component
3
2.2 ISO Standards:
that articulates against the counter surface of the natural or
ISO 5832–3 Implants for Surgery—Metallic Materials—
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F2887 − 12 F2887 − 17
Standard Specification for
1
Total Elbow Prostheses
This standard is issued under the fixed designation F2887; 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 total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used
to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion
of the human elbow joint complex.
1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked
and non-linked designs and components implanted with or without use of bone cement.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those
characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this
specification does not itself mean that a device that will provide satisfactory clinical performance.
1.4 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)
F451 Specification for Acrylic Bone Cement
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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)
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
F1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium
Phosphate/Metallic Coatings
F1223 Test Method for Determination of Total Knee Replacement Constraint
F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
1
This test method 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, 2012Jan. 1, 2017. Published March 2013March 2017. Originally approved in 2012. Last previous edition approved in 2012 as F2887-12.
DOI: 10.1520/F2887–12.10.1520/F2887–17.
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 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 ----------------------
F2887 − 17
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F1814 Guide for Evaluating Modular Hip and Knee Joint Components
F2759 Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used i
...

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1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.  
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1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1)2 of plantar flexion, as determined by non-clinical testing.  
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ASTM F3576-22(Practice)
Standard Practice for Recording the Exoskeleton Test Configuration

SIGNIFICANCE AND USE
5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton configuration. Exoskeleton tests can also be replicated across similar or different exoskeletons by using this practice to record the exoskeleton test configuration in a standardized way.  
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ASTM F3581-22(Test Method)
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SIGNIFICANCE AND USE
5.1 Hurdle designs can vary greatly in, for example: hurdle geometry, surface coatings, and coverings for a variety of industries. Fig. 1 shows examples of various hurdles.  
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1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, for traversing hurdles.  
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ASTM F3582-22(Test Method)
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SIGNIFICANCE AND USE
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5.3 The standard test setup and apparatus (see Section 6) is specified to be easily fabricated. This facilitates evaluation and replication of gap tests by exoskeleton sectors. The standard test setup and apparatus can also be used to support training (see Practice F3444/F3444M) and to establish proficiency of exoskeleton users, as well as provide manufacturers with information about the usefulness of their exoskeleton(s) for tasks.  
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ASTM F3583-22(Test Method)
Standard Test Method for Exoskeleton Use: Beams

SIGNIFICANCE AND USE
5.1 Beams and beams with platforms can vary greatly in, for example: length, width, height, quantity, geometry, surface coatings, and for a variety of industries. Fig. 2 shows examples of various beams and beams with platforms.
FIG. 2 Example Beams: (a) Steel Construction Beams; (b) Steel Construction Beam to a Platform; (c) Log Construction Beam; (d) Playground Log Beam; (e) Log Beam across Water; and (f) Balance Beam used for Gymnastics  
5.2 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Traversing beams are used in many tasks performed and may include, for example, upper, lower, or full body movement in order to complete the task. Dependent upon the task, it may require people to traverse various ground and beam surfaces while wearing an exoskeleton. For example, an exoskeleton may be used to help during construction tasks where workers in exoskeletons traverse beams or beams and platforms with and without carrying loads, indoors or outdoors, as part of their daily activities. The testing results of exoskeletons shall describe, in a statistically significant way (see guidance in Appendix X1), how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton.  
5.3 This test method addresses exoskeleton safety and performance requirements expressed by manufacturing, emergency responders, military, or other organizations requesting this test. The safety and performance data captured within this test method are indicative of the test exoskeleton’s and the exoskeleton user’s capabilities. Having available direct information from tested exoskeleton(s) with associated performance data to guide procurement and deployment decisions is essential to exoskeleton purchasers an...
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, when traversing beams.  
1.1.2 Exoskeletons shall possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational.  
1.1.3 Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to traverse beams, as intended by the user or test requestor, while using an exoskeleton, is essential for exoskeleton deployment for a variety of tasks (for example, ascending/descending stairs, ramps, hills). This test method specifies test setup, procedure, and recording to standardize this beams task for testing exoskeleton user movement.  
1.1.4 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing, traversing gaps, hurdles, stairs, beams, slopes, various types of floor surfaces or terrains, or confined spaces, or combinations thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements.  
1.1.5 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods for evaluating exoskeleton capability requirements. This beams test method is a part of the test suite. The setup, procedure,...

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ASTM F3584-22(Test Method)
Standard Test Method for Exoskeleton Use: Obstacle Avoidance: Walking

SIGNIFICANCE AND USE
5.1 Obstacles can vary greatly in, for example: length, width, height, quantity, geometry, and for a variety of industries. Fig. 2 shows examples of various obstacles.  
FIG. 2 Example Obstacles in: (a) Road Construction; (b) Warehouse; (c) Manufacturing: Floor; (d) Manufacturing: Overhead; (e) Military Obstacle Course  
5.2 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Many tasks involve avoiding obstacles, and may include for example, upper, lower, or full body movement in order to complete the task. As there are infinite obstacles and ways that obstacle courses can be designed, this test method addresses obstacle avoidance while walking through a standard set of obstacles. Dependent upon the task, it may require people to traverse various environmental conditions (for example, ground) and avoid obstacles while wearing an exoskeleton. For example, an exoskeleton may be used to help during construction or in medical facilities where workers in exoskeletons avoid obstacles with and without carrying loads as part of their daily activities. In military, manufacturing, and response areas, exoskeleton users may for example, step over or under, side-step between, or walk around obstacles, or combinations thereof, to perform the task at hand. Variations to obstacle avoidance may include, for example, increased user speed/momentum, load handling, and distractions that may change user performance when avoiding obstacles. The testing results of exoskeletons shall describe, in a statistically significant way (see guidance in Appendix X1), how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton.  
5.3 This test method addresses exoskeleton safety and performance require...
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, when avoiding obstacles.  
1.1.2 Exoskeletons shall possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational.  
1.1.3 Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to avoid obstacles while walking, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks (for example, ascending/descending stairs, crossing gaps and hurdles, balancing on a beam). This test method specifies test setup, procedure, and recording to standardize this obstacle avoidance task for testing exoskeleton user movement.  
1.1.4 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing; traversing gaps, hurdles, stairs, slopes; avoiding obstacles, on various types of floor surfaces or terrains, or within confined spaces, or combinations thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements while also allowing test repeatability.  
1.1.5 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods ...

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ASTM F3614-22(Practice)
Standard Practice for Recording the Exoskeleton User Information

SIGNIFICANCE AND USE
5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton user. Exoskeleton test results can be compared across users to determine exoskeleton usefulness, exoskeleton capability for particular users or groups of users, and standardized reporting of user information allows organizations to better replicate tests.  
5.2 Limitations of the practice are that not all exoskeletons can or have the same fit to all users and therefore may change the exoskeleton capabilities. For example, as users vary in size, shape, gender, etc., an exoskeleton that fits one user may allow an increase or decrease in torque applied to the arms, legs, etc. as compared to another user, especially users at the upper and lower limits of manufacturer-suggested exoskeleton sizing. Another example is that prior surgeries or pain may affect measured exoskeleton performance as the user may, for example, favor use of one limb to another or may move different when tested with the exoskeleton versus without the exoskeleton.  
5.3 Additional user measurement information may be found in the following references:
Note 1: The measurements in these references may not consider measurements of the user when dressed in appropriate clothing (for example, shoes – see 6.3.12 – 6.3.14) that will be worn when using an exoskeleton.  
5.3.1 2012 Anthropometric Survey (ANSUR II6) of U.S. Army Personnel: Methods and Summary Statistics,  
5.3.2 United States Air Force Research Laboratory Civilian American and European Surface Anthropometry Resource (CAESAR7) Final Report,  
5.3.3 Tables D6240/D6240M,  
5.3.4 Tables D8077/D8077M,  
5.3.5 Tables D7878/D7878M,  
5.3.6 Tables D6960/D6960M,  
5.3.7 Terminology D5219,  
5.3.8 Tables D8241/D8241M,  
5.3.9 Practice E3003,  
5.3.10 Practice F1731, and  
5.3.11 ISO 7250-1.
SCOPE
1.1 This practice describes a means to record the exoskeleton user information when testing. The practice provides a method for recording exoskeleton user: general information, measurements, activity level, experience with exoskeletons, prior injuries, and other pertinent information that may impact exoskeleton testing.  
1.2 This practice is intended to be used with other exoskeleton test methods and practices to provide a clear representation of the exoskeleton user being tested; provides a basis for comparison of the test circumstances across different exoskeletons, users, tests, or all three; and allows a test to be recreated.  
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are not precise mathematical conversions to imperial units. They are close approximate equivalents for the purpose of specifying exoskeleton characteristics while maintaining repeatability and reproducibility of the test method results. These values given in parentheses are provided for information only and are not considered standard.  
1.4 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.  
1.5 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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