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ASTM F2887-23

(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.  
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.

General Information

Status
Published
Publication Date
28-Feb-2023
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

Relations

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 F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
Effective Date
15-Jun-2020

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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.
Designation: F2887 − 23
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 F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.1 This specification covers total elbow replacement (TER)
tions (UNS R30605)
prostheses and hemi-elbow replacement (“hemi”) prostheses
F136 Specification for Wrought Titanium-6Aluminum-
used to provide functioning articulation by employing humeral,
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
ulnar, and/or radial components that allow for the restoration of
Implant Applications (UNS R56401)
motion of the human elbow joint complex.
F451 Specification for Acrylic Bone Cement
1.2 Included within the scope of this specification are elbow
F565 Practice for Care and Handling of Orthopedic Implants
prosthesis components for primary and revision surgery with
and Instruments
linked and non-linked designs and components implanted with
F648 Specification for Ultra-High-Molecular-Weight Poly-
or without use of bone cement.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 This specification is intended to provide basic descrip-
plants
tions of material and prosthesis geometry. In addition, those
F732 Test Method for Wear Testing of Polymeric Materials
characteristics determined to be important to the in vivo
Used in Total Joint Prostheses
performance of the prosthesis are defined. However, compli-
F746 Test Method for Pitting or Crevice Corrosion of
ance with this specification does not itself mean that a device
Metallic Surgical Implant Materials
will provide satisfactory clinical performance.
F748 Practice for Selecting Generic Biological Test Methods
1.4 The values stated in SI units are to be regarded as
for Materials and Devices
standard. No other units of measurement are included in this
F799 Specification for Cobalt-28 Chromium-6 Molybdenum
standard.
Alloy Forgings for Surgical Implants (UNS R31537,
1.5 This international standard was developed in accor- R31538, R31539)
dance with internationally recognized principles on standard- F983 Practice for Permanent Marking of Orthopaedic Im-
ization established in the Decision on Principles for the
plant Components
Development of International Standards, Guides and Recom-
F1044 Test Method for Shear Testing of Calcium Phosphate
mendations issued by the World Trade Organization Technical
Coatings and Metallic Coatings
Barriers to Trade (TBT) Committee.
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
F1377 Specification for Cobalt-28Chromium-6Molybdenum
1
Powder for Medical Devices (UNS R30075, UNS
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
R31537, and UNS R31538)
Subcommittee F04.22 on Arthroplasty.
F1472 Specification for Wrought Titanium-6Aluminum-
Current edition approved March 1, 2023. Published March 2023. Originally
4Vanadium Alloy for Surgical Implant Applications (UNS
approved in 2012. Last previous edition approved in 2017 as F2887 – 17. DOI:
10.1520/F2887-23.
R56400)
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F1537 Specification for Wrought Cobalt-28Chromium-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6Molybdenum Alloys for Surgical Implants (UNS
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. R31537, UNS R31538, and UNS R31539)
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2887 − 23
F1580 Specification for Titanium and Titanium-6 Porous-Coated Uncemented Pros
...

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 − 17 F2887 − 23
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 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.
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.
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
1
This test method 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 Jan. 1, 2017March 1, 2023. Published March 2017March 2023. Originally approved in 2012. Last previous edition approved in 20122017 as
F2887F2887 – 17.-12. DOI: 10.1520/F2887–17.10.1520/F2887-23.
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 − 23
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-28 Chromium-6 Molybdenum 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 Medical Devices (UNS R30075, UNS R31537, and
UNS R31538)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537 Specification for Wrought Cobalt-28
...

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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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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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SIGNIFICANCE AND USE
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SIGNIFICANCE AND USE
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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,  
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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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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) performance or safety, or both, of usage by the exoskeleton user (see 1.4) for gaps.  
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. Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to step over gaps, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks. This test method specifies test setup, procedure, and recording to standardize this gaps task for testing exoskeleton user movement.  
1.1.3 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, stairs, 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.  
1.1.4 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 gaps test method is a part of the test suite. The setup, procedure, and apparatuses associated with the test methods challenge speci...

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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...
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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 F3613-22(Practice)
Standard Practice for Recording the Exoskeleton Fit to the User

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 fit to the user. Exoskeleton tests can also be replicated across similar or different exoskeletons by using this practice to record the exoskeleton fit to the user for a test in a standardized way.  
5.2 Limitations of the practice are that not all exoskeletons have the same connections to the body and fit to all users, and therefore, fit to the user may change the exoskeleton capabilities. For example, as users vary in size, shape, gender, etc., an exoskeleton that is fit to 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 an exoskeleton that is not fit properly to a user may be uncomfortable, and as a result the user may not perform tasks as long, as fast, as strong/delicately, or many other possible outcomes.  
5.3 It is expected that all exoskeleton tests require the exoskeleton to be fit properly to the user according to manufacturer specifications. However, as testing exoskeletons can vary, so can fit to the user, and variations in fit may also be tested. For example, a test may be performed with the exoskeleton not fit properly to the users’ legs (for example, longer fit on shorter legs) to evaluate performance changes when the task requires the user to stand on their toes. Should exoskeleton tests be performed with the exoskeleton not fit properly to the user, the test requestor should verify with the manufacturer that the exoskeleton will not harm the user as a result of a bad fit, and provide this information to the test administrator to record on the test report.  
5.4 Additional fit and measurement information may be found in Terminology D5219, Practice E3003, and Practice F1731.
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1.1 This practice describes a means to record the exoskeleton fit to the user when testing. The practice provides a method for recording exoskeleton: alignment to the user, component distances from the body, sizing, and subjective comfort using a standard recording method.  
1.2 This practice is intended to be used with other exoskeleton test methods and practices to provide a clear representation of the exoskeleton fit to the user measured along body planes; provides a basis for comparison of the test circumstances across different exoskeletons or tests, or both; 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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ASTM F3578-22(Test Method)
Standard Test Method for Evaluating Exoskeleton Fall Risk due to Stumbling

SIGNIFICANCE AND USE
5.1 There is strong evidence that exoskeletons can physically augment and assist users. They are typically designed and optimized with specific tasks in mind and initially tested in controlled lab or field settings. However, in the real world exoskeletons encounter less structured environments and situations (for example, hospital rooms, factory floors, construction sites, or even personal homes). In order to accelerate the adoption of exoskeletons in society, understanding their safety in the presence of perturbations is helpful. The testing results of the exoskeleton shall describe the extent to which the exoskeleton improves, inhibits, or maintains a user’s ability to recover from stumbles, thus providing exoskeleton wearers and prescribers (for example, patients, clinicians, industry leaders, factory workers) with additional information about device performance and expectations.  
5.2 The standard test apparatus and setup (see Section 6) is specified to be easily fabricated and implemented in gait or motion analysis laboratories. Variants of the apparatus, control algorithm, and test setup are acceptable to allow implementation in various lab settings with ranging experimental capabilities. The standard test setup and apparatus can also be used to support training and establish proficiency of exoskeleton users, as well as provide manufacturers with information about the performance of their exoskeleton(s) for tasks.
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1.1 Purpose:  
1.1.1 The purpose of this test method is to evaluate the extent to which an exoskeleton (see Section 3) improves, inhibits, or maintains (that is, does not affect) a user’s ability to recover from a stumble perturbation.  
1.1.2 Exoskeletons are designed to assist specific tasks and initially tested in controlled lab or controlled field settings. However, in the real world exoskeletons encounter less structured environments and situations (for example, hospital rooms, factory floors, construction sites). Even without exoskeletons people will stumble (that is, trip) or scuff their foot. It would be helpful to understand how wearing an exoskeleton affects a person’s ability to recover from a stumble perturbation. Is one’s ability to recover hampered, enhanced, or unaltered when using an exoskeleton? This test method specifies test setup, procedure, and recording to standardize testing exoskeleton user stumble recovery.  
1.2 Performing Location—This test method shall be performed in a testing laboratory where the specified apparatus and environmental conditions are available and implemented.  
1.3 Units—The values stated in SI units are to be regarded as the standard. The values given in parentheses are not precise mathematical conversions to inch-pound units. They are close approximate equivalents for the purpose of specifying material dimensions or quantities that are readily available to avoid excessive fabrication costs of test apparatuses 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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ASTM F3518-21(Guide)
Standard Guide for Quantitative Measures for Establishing Exoskeleton Functional Ergonomic Parameters and Test Metrics

SIGNIFICANCE AND USE
4.1 This guide provides a set of recommended quantitative measures which can be used to assess the task or human readiness, or both, of exoskeletons. All of the quantitative measures are used in ergonomic research to assist in objectively concluding the efficacy of an assessed metric.  
4.2 Not every element of this guide may be applicable to all exoskeleton components or configurations. Nor are all the quantitative measures herein exhaustive. Selection of quantitative measures should be done based on the uncertainties surrounding the end use application of the exoskeleton. It is the manufacturer’s responsibility to determine which portions of this guide, and the corresponding measures, are applicable to their exoskeletons.  
4.3 The ability to reproduce analysis between exoskeleton usage vs. non-exoskeleton usage is critical criteria in using a quantitative measures approach. A control method for reproducibility in a quantitative measures approach is a repeated measures design. A repeated measures design involves multiple measures of the same variable taken on the same end user, either under different conditions or over two or more time periods. The salient aspect of a repeated measures design is using the end user as the control.
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1.1 This guide provides quantitative measures for assessing one or more specific ergonomic parameters with respect to exoskeletons. Furthermore, this guide should be used in conjunction with Practice F3474, Guide F3519, and Standard Guide for The Application of Ergonomics to Prevent Injury During Exoskeleton Use2.  
1.2 This guide provides quantitative measures for the design, use, and construction of exoskeletons within the domains of industry, military, medical, first responders, and recreational.  
1.2.1 Quantitative measures are a type of data that can be put into a numerical value. This type of measure allows statistical analysis to be performed on the data to yield an objective result.  
1.3 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this 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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