iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F2665-09(2014)

(Specification)

Standard Specification for Total Ankle Replacement Prosthesis

Standard Specification for Total Ankle Replacement Prosthesis

SCOPE
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.  
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use.  
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to in vivo performance of the prosthesis are defined.  
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 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
14-Jul-2014
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

Buy Standard

ASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement ProsthesisASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement Prosthesis
PreviousNext
Technical specification
ASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement Prosthesis
English language
7 pages
sale 15% off
Preview
sale 15% off
Preview
REDLINE ASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement ProsthesisREDLINE ASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement Prosthesis
PreviousNext
Technical specification
REDLINE ASTM F2665-09(2014) - Standard Specification for Total Ankle Replacement Prosthesis
English language
7 pages
sale 15% off
Preview
sale 15% off
Preview

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F2665 −09 (Reapproved 2014)
Standard Specification for
1
Total Ankle Replacement Prosthesis
This standard is issued under the fixed designation F2665; 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 F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
1.1 This specification covers total ankle replacement (TAR)
F90 Specification for Wrought Cobalt-20Chromium-
prostheses used to provide functioning articulation by employ-
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
ing talar and tibial components that allow for a minimum of
2 tions (UNS R30605)
15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as
F136 Specification for Wrought Titanium-6Aluminum-
determined by non-clinical testing.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.2 Included within the scope of this specification are ankle
Implant Applications (UNS R56401)
componentsforprimaryandrevisionsurgerywithmodularand
F138 Specification for Wrought 18Chromium-14Nickel-
non-modulardesigns,bearingcomponentswithfixedormobile
2.5Molybdenum Stainless Steel Bar andWire for Surgical
bearing designs, and components for cemented and/or cement-
Implants (UNS S31673)
less use.
F451 Specification for Acrylic Bone Cement
1.3 This specification is intended to provide basic descrip-
F562 Specification for Wrought 35Cobalt-35Nickel-
tions of material and prosthesis geometry. In addition, those
20Chromium-10Molybdenum Alloy for Surgical Implant
characteristics determined to be important to in vivo perfor-
Applications (UNS R30035)
mance of the prosthesis are defined.
F563 Specification for Wrought Cobalt-20Nickel-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.4 The values stated in SI units are to be regarded as
for Surgical Implant Applications (UNS R30563) (With-
standard. No other units of measurement are included in this
4
drawn 2005)
standard.
F565 PracticeforCareandHandlingofOrthopedicImplants
1.5 This standard does not purport to address all of the
and Instruments
safety concerns, if any, associated with its use. It is the
F648 Specification for Ultra-High-Molecular-Weight Poly-
responsibility of the user of this standard to establish appro-
ethylene Powder and Fabricated Form for Surgical Im-
priate safety and health practices and determine the applica-
plants
bility of regulatory limitations prior to use.
F732 Test Method for Wear Testing of Polymeric Materials
Used in Total Joint Prostheses
2. Referenced Documents
F745 Specification for 18Chromium-12.5Nickel-
3
2.1 ASTM Standards:
2.5Molybdenum Stainless Steel for Cast and Solution-
F67 Specification for Unalloyed Titanium, for Surgical Im-
Annealed Surgical Implant Applications (Withdrawn
plant Applications (UNS R50250, UNS R50400, UNS
4
2012)
R50550, UNS R50700)
F746 Test Method for Pitting or Crevice Corrosion of
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Metallic Surgical Implant Materials
Alloy Castings and Casting Alloy for Surgical Implants
F748 PracticeforSelectingGenericBiologicalTestMethods
(UNS R30075)
for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum
1
This specification is under the jurisdiction of ASTM Committee F04 on
Alloy Forgings for Surgical Implants (UNS R31537,
Medical and Surgical Materials and Devices and is the direct responsibility of
R31538, R31539)
Subcommittee F04.22 on Arthroplasty.
Current edition approved July 15, 2014. Published September 2014. Originally
F981 Practice for Assessment of Compatibility of Biomate-
approved in 2009. Last previous edition approved in 2009 as F2665 - 09. DOI:
rials for Surgical Implants with Respect to Effect of
10.1520/F2665-09R14.
Materials on Muscle and Bone
2
The boldface numbers in parentheses refer to a list of references at the end of
this standard.
3
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
4
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 ----------------------
F2665−09 (2014)
F983 Practice for Permanent Marking of Orthopaedic Im- 3.1.3 flexion, n—rotation of the talar component relative to
plant Components the tibial component around the medial-lateral axis. Flexion is
F1044 Test Method for Shear Testing of Calcium Phosphate considered positive wh
...

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: F2665 − 09 F2665 − 09 (Reapproved 2014)
Standard Specification for
1
Total Ankle Replacement Prosthesis
This standard is issued under the fixed designation F2665; 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 ankle replacement (TAR) prostheses used to provide functioning articulation by employing
2
talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as determined
by non-clinical testing.
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and
non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless
use.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those
characteristics determined to be important to in vivo performance of the prosthesis are defined.
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 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
3
2.1 ASTM Standards:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
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)
F451 Specification for Acrylic Bone Cement
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-5Iron Alloy for Surgical Implant
4
Applications (UNS R30563) (Withdrawn 2005)
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 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 Feb. 1, 2009July 15, 2014. Published June 2009September 2014. Originally approved in 2009. Last previous edition approved in 2009 as F2665
- 09. DOI: 10.1520/F2665-09.10.1520/F2665-09R14.
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
3
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.
4
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2665 − 09 (2014)
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
4
Implant Applications (Withdrawn 2012)
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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM F2887-23(Specification)
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.

  • Technical specification
    9 pages
    English language
    sale 15% off
  • Technical specification
    9 pages
    English language
    sale 15% off
ASTM
ASTM F2665-21(Specification)
Standard Specification for Total Ankle Replacement Prosthesis

SCOPE
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.  
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use.  
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.  
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 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.  
1.6 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.

  • Technical specification
    8 pages
    English language
    sale 15% off
  • Technical specification
    8 pages
    English language
    sale 15% off
ASTM
ASTM F3295-18(Guide)
Standard Guide for Impingement Testing of Total Disc Prostheses

SIGNIFICANCE AND USE
5.1 This guide can be used to develop test parameters for evaluating fatigue and wear behavior of IVD prostheses under impingement loading. It must be recognized, however, that there are likely many possible impingement conditions for a given IVD prosthesis.  
5.2 The user should attempt to determine the clinically relevant and geometrically possible impingement conditions and dictated by the design and impingement wear test parameters that may result in wear and fatigue damage for the IVD prosthesis. The user should also attempt to select the device size which will represent a worst case for the impingement conditions and parameters selected.  
5.3 The user should reference and utilize existing sources of information to identify the impingement test parameters that produce the clinically relevant impingement wear and damage for their IVD prosthesis. Prior clinical experience with the device design may aid in the development of impingement test parameters through analysis of device retrievals and radiographs. However, prior clinical experience with the IVD being tested should not be considered as a prerequisite for performing impingement testing.  
5.4 This guide details a three-step process for assessing device impingement under a selected set of conditions:  
5.4.1 The user selects previously identified impingement conditions, one at a time, or clinically observed conditions.  
5.4.2 The user selects the worst-case size of device to apply the selected conditions.  
5.4.3 Solid modeling and the quasistatic test method should be employed to assess the impingement condition and determine the impingement test parameters – most importantly, the angular displacement limits to be used in the impingement wear test.  
5.4.4 The impingement wear test is then conducted using the impingement test parameters.  
5.5 This guide serves to evaluate devices with various designs, materials (i.e., metal-on-metal versus polymer-on-polymer), and stiffness in the impingement reg...
SCOPE
1.1 This standard is intended to provide guidance on the evaluation of wear and fatigue characteristics of total disc prostheses under cyclic impingement conditions.  
1.2 This guide describes impingement testing of devices with articulating components. The user is cautioned that the methods described herein are intended to produce an impingement condition which may or may not be indicative of clinical performance and which may or may not be consistent with the intended use of the device, and that this should be considered when interpreting the data. Clinically, total disc prostheses should always be implanted per labeling and the manufacturer’s instructions for use.  
1.3 Impingement has been observed in retrievals among several total disc prosthesis designs; however, impingement is not necessarily associated with device or clinical failure. It is the intent of this guide to investigate possible impingement-induced wear and mechanical failure modes associated with device design, as well as potential mechanical failure modes associated with clinical events such as subsidence, malpositioning, and improper implant sizing. Note that mechanical failure may or may not be associated with functional failure.  
1.4 It is recommended that the user define the bearing and non-bearing features of the intervertebral disc (IVD) prosthesis and evaluate the performance of the IVD prosthesis under Mode 1 wear by using Guide F2423 or ISO 18192-1 prior to use of this guide. This standard is not intended to provide guidance on Mode I testing.  
1.5 The goal of this guide is to evaluate impingement in IVD prostheses regardless of the intended region of the spine (cervical or lumbar), material or material combinations (ceramic, metal, polymer), and bearing type (fixed or mobile).  
1.6 It is the intent of this guide to enable comparison of IVD prostheses with regard to wear and fatigue characteristics when tested under the specified cond...

  • Guide
    15 pages
    English language
    sale 15% off
ASTM
ASTM F2887-23(Specification)
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.

  • Technical specification
    9 pages
    English language
    sale 15% off
  • Technical specification
    9 pages
    English language
    sale 15% off
ASTM
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.  
5.2 Limitations of the practice are that not all exoskeletons have the same capabilities or configuration parameters. For example, for capabilities, an exoskeleton that moves the legs with electromyography during rehabilitation may behave differently in repeated use over time or within different gait courses (for example, straight or curved). For configuration, an exoskeleton that moves the legs with electromyography during rehabilitation may have varying signal gain/amplification settings.
SCOPE
1.1 This practice describes a means to record the exoskeleton configuration when testing. This practice provides a method for recording exoskeleton hardware and software control parameters.  
1.2 This practice: contextualizes the exoskeleton configuration during a test, including the identification and adjustment of main configuration parameters and the addition of other equipment (for example, cameras, markers) used during tests; provides a basis for comparison of the test circumstances across different exoskeletons or tests, or both (for example, varying power or spring settings, prior exoskeleton use, maximum control settings); 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.

  • Standard
    10 pages
    English language
    sale 15% off
ASTM
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 ...

  • Standard
    15 pages
    English language
    sale 15% off
ASTM
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.
SCOPE
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.

  • Standard
    10 pages
    English language
    sale 15% off
ASTM
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.

  • Standard
    17 pages
    English language
    sale 15% off
ASTM
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,...

  • Standard
    21 pages
    English language
    sale 15% off
ASTM
ASTM F3581-22(Test Method)
Standard Test Method for Exoskeleton Use: Hurdles

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.  
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. Hurdles are used in many tasks performed and may include, for example, upper, lower, or full body movement in order to complete the task. For example, an exoskeleton may be used to help rehabilitate a patient who suffered a traumatic injury. And in manufacturing, warehousing, and other occupations, and other similar environments, workers in exoskeletons may traverse hurdles (for example, obstacles) in the walkways while carrying or not carrying loads, indoors or outdoors, as part of their daily activities. The testing results of exoskeletons shall describe, in a statistically significant way, 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 and users.  
5.4 The testing results of the candidate exoskeleton(s) shall describe, in a statistically significant way, how reliably the exoskeleton user is able to negotiate hurdles. The test apparatus described in Section 6 is intended to be a single or set of hurdles where repeatable re...
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, for traversing hurdles.  
1.1.2 Exoskeletons 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 traverse hurdles, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks (for example, traversing logs, objects). This test method specifies test setup, procedure, and recording to standardize this hurdles 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, hurdles, stairs, slopes, various types of floor surfaces or terrains, or confined spaces, or any combination 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 hurdles test method is a part of the test suite. The setup, procedure, and apparatuses associated wi...

  • Standard
    15 pages
    English language
    sale 15% off