F48.02 - Human Factors and Ergonomics

SIGNIFICANCE AND USE
4.1 The current state of research provides limited evidence to directly support the use of exoskeletons by injured workers for Return to Work (RTW). However, there is research to support using certain exoskeletons to reduce strain and fatigue, as well as improve productivity and work quality. Reductions in strain and fatigue can reduce the risk for injury. To date, the best conclusion is that there is a potential opportunity for exoskeletons to help injured workers RTW, but precise outcomes may be unpredictable at this time. Professional management by a multidisciplinary team (see 5.8) of the following process is recommended. This practice is intended to serve as an example of a potential process that can be used when an exoskeleton is indicated for appropriate workers seeking to RTW. The first step is to consider the criteria in Section 5. If the criteria are met, use the procedure in Section 6 for managing the use of exoskeletons by injured workers for RTW.
SCOPE
1.1 The purpose of this practice is to discuss the potential benefits and risks of exoskeletons when used by workers during the Return to Work (RTW) process following an injury or illness, and to provide guidance to anyone considering their use during the modified/transitional duty period. The primary objectives of any exoskeleton used in a RTW capacity are to facilitate the natural healing process, prevent an exacerbation of an existing injury or illness, prevent further injuries or illnesses from developing, reduce the number of modified/transitional duty days, reduce the number of visits to healthcare providers for medical treatments, and assist the worker with return to full duty without restrictions. The exoskeleton must not aggravate the original injury or illness, nor cause a secondary injury or illness. Successful RTW constitutes an injured worker’s ability to tolerate all of the demands of his/her job without reinjury, perform essential job functions, or return to work as per the decisions and directions of the worker’s physician and employer. In some cases, workers may continue to use the exoskeletons after full duty RTW for risk reduction, injury prevention, or to continue to perform essential job functions. Exoskeleton usage that continues beyond full duty RTW for these purposes is beyond the scope of this particular standard practice.  
1.2 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.  
1.3 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.

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.

SIGNIFICANCE AND USE
4.1 Development of exoskeleton technologies requires careful analysis of potential risks that may be associated with their use. Failure to adequately assess risks may give rise to hazardous situations at many instances of exoskeleton use, for example during completion of human trials, during exoskeleton demonstrations in trade shows, as well as during exoskeleton training, wear, operation, transportation, maintenance, and disposal.  
4.2 This guide provides a minimum set of hazards that should be considered by producers when analyzing and mitigating risks related to exoskeletons. This set of hazards should be supplemented with other hazards that may reflect unique safety concerns relevant to the exoskeleton technology and application. The following sources may provide additional insight based on exoskeleton technology and application:  
4.2.1 IEC 60601 series;  
4.2.2 IEC 80601-2-78;  
4.2.3 ISO/DIS 13482;  
4.2.4 Product standards established by military agencies (examples are NATO standards and United States Military Standards).  
4.3 For each listed hazard, one example of harm scenario and examples of possible harm are provided. These examples are used to illustrate potential safety consequences related to such hazards. They do not reflect a comprehensive list of all possible acute or chronic injuries that may result from exoskeleton use. Additionally, although this guide does not address hazards that may result in damage of objects, these should be considered as well during the risk analysis process.  
4.4 This guide does not provide detailed guidance for application of risk management processes to exoskeletons. However, the producer should use a structured approach to identify and monitor hazards, and mitigate related risks throughout the exoskeleton life-cycle. Additional guidance on risk management can be found in the following standards:  
4.4.1 ISO 31000;  
4.4.2 ISO 14971.  
4.5 This guide does not supersede any established laws or regulations ...
SCOPE
1.1 This guide lists typical hazards that should be considered by exoskeleton producers when analyzing and managing potential risks related to exoskeletons.  
1.2 Where possible, this guide provides references to agency standards, regulations, or guidelines for assessment of risks related to these hazards and for application of risk reduction measures.  
1.3 This guide applies to all exoskeleton types, regardless of the applications of the technology such as consumer, industrial, medical, military, and emergency management services.  
1.4 Units—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.

SIGNIFICANCE AND USE
4.1 There is evidence to support use of occupational exoskeletons to support work tasks and activities. It is recognized that organizations, job responsibilities, and working contexts vary widely. Additionally, a wide array of exoskeletons are becoming available on the market. Exoskeletons vary in terms of complexity, form and mass, body coverage, and function. Certification programs for occupational exoskeletons are not available at this time. As such, at the present time no mechanisms exist to guarantee that circumstantial risk evaluation was performed on exoskeletons or whether these evaluations reflect the real working context in which exoskeletons will be implemented.  
4.2 This guide provides a minimum baseline for assessing risks that may arise from exoskeleton interaction with existing and task-specific environments. The working document presented in Appendix X1 can be used to support decision making at different stages of exoskeleton implementation, such as:  
4.2.1 Purchase—It can highlight safety concerns that may arise from introduction of a given exoskeleton technology in a specific work context;  
4.2.2 Implementation of Risk Reduction Measures—It can highlight residual risks that require risk reduction measures;  
4.2.3 Detection of Unknowns—It can lead to definition of additional steps that are needed to satisfy risk assessment for potentially hazardous situations;  
4.2.4 Risk Monitoring—It can be used as a “living document” to monitor residual risks throughout the use period of the exoskeleton.  
4.3 Harm scenarios described in this guide primarily reflect situations that may result in acute and observable injury or harm to a person. This guide is not suited for assessment of potential exoskeleton-to-task incompatibilities that may result in chronic, cumulative, or long-term injuries. However, these should be considered as part of any exoskeleton selection and implementation process. Guidelines on evaluation of risk factors that may lead to ...
SCOPE
1.1 When implementing exoskeletons in real-world work environments, exoskeleton interaction with various components of a given task and its environment can generate a number of risks. This guide provides guidance for conducting contextual risk assessment. A working document is provided in Appendix X1 to allow initiation of the risk assessment process. It can be used to describe tasks, break the tasks down into task elements, anticipate related harm scenarios (a series of typical harm scenarios are provided), assess related risks, and detect scenarios that may require further analysis or implementation of risk reduction measures.  
1.2 This guide applies to exoskeletons administered by employers to paid workers or professionals to support work-related tasks and activities.  
1.3 This guide addresses risks that may result in acute and observable injury and harm. This guide does not address the following topics and concerns related to exoskeleton use:  
1.3.1 Assessment and prevention of risk factors that can lead to chronic, cumulative, or long-term injuries;  
1.3.2 Use of exoskeletons to support rehabilitation and return to work;  
1.3.3 Risks related to storage and use of personal information;  
1.3.4 Risks that may result in damage of objects; and  
1.3.5 Financial risks.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 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 St...

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.
SCOPE
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.

SIGNIFICANCE AND USE
3.1 This guide describes a template of written considerations that should be provided by the manufacturer to the purchaser related to the documenting of exoskeleton analysis. Adherence to this guide allows analysis results of varied exoskeleton manufacturers to be compared by a purchaser with respect to their end user needs.  
3.2 Not every element of this guide may be applicable to all exoskeleton components or configurations. It is the manufacturer’s responsibility to determine which portions of this guide are applicable to their exoskeletons for analysis reporting.
SCOPE
1.1 This guide provides a structure for exoskeleton manufacturers to document their analysis. Furthermore, this guide should be used in conjunction with Practice F3474, Guide F3518, Standard Guide for The Application of Ergonomics to Prevent Injury During Exoskeleton Use2 and other future documents.  
1.2 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.  
1.3 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.

SIGNIFICANCE AND USE
2.1 This practice describes what measure should be performed during the near (hours/days), mid (days/weeks), and far (months/years) stages of exoskeleton evaluation (Fig. 1). The functional conditions and metrics with respect to each task method are assessed from the body area(s) impacted by the exoskeleton (for example, upper body, lower body, or both). These may be within as well as distant to the body areas impacted by the exoskeleton (for example, an upper body exoskeleton may have impacts on the trunk and spine). Desired effects as well as unintended encumbrances to the user’s body are important considerations. The evaluation will occur within the context relevant to the end-use application of the exoskeleton’s implementation. This practice pertains to the industry, military, medical, first responders, and recreational domains, but other domains may arise in the future and will need to be considered. Each domain is unique unto itself; however, the task methods and metrics collected may be unique or overlap across any number of user domains.
FIG. 1 Exoskeleton Assessment Decision Tree  
2.2 Task methods and their metrics are either administered in a laboratory environment, field environment, or both laboratory and field environments. Where not otherwise specified, patient functional outcome measures and pain are key metrics that should be considered for testing performed in the medical domain. Exoskeleton producers or researchers, or both, may also want to consider different types of imaging such as X-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound, and nuclear medicine imaging. Additionally, exoskeleton producers or researchers, or both, may also wish to carry out neuroimaging such as, but not limited to, structural and functional and diffusion MRI, magnetoencephalography (MEG), electroencephalography (EEG), positron emission tomography (PET), or near infrared spectroscopy (NIRS) to understand the cognitive and neurophysiol...
SCOPE
1.1 This practice provides a recommended approach and a set of options for assessing one or more specific ergonomic parameters with respect to human users of exoskeletons.  
1.2 This practice provides functional ergonomic criteria to consider for the design, production, and evaluation of exoskeletons within the domains of industry, military, medical, first responders, and recreational. When designing exoskeletons, natural unassisted human kinematics and kinetics, as well as the resulting strain and fatigue experienced by the user should be salient design parameters. Any changes in the natural unassisted human kinematics and kinetics may impact the exoskeleton’s effectiveness in augmenting user performance. Therefore, the defining principle of this practice is to establish objective measures that can be selected from to assess human kinematics and kinetics, as well as the resulting strain and fatigue experienced by the user within the task context of the exoskeleton’s end use application.  
1.3 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.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 This practice establishes the minimum training criteria for exoskeleton users.  
4.2 This practice does not supersede any established laws or regulations of international, national, federal, state, tribal, local, or regional governments.  
4.3 A commonly used training practice is for a competent, qualified, or certified trainer to provide to the student with written, visual, and verbal training materials that elementally breakdown the intended subject matter into a series of achievable modules. The trainer describes and demonstrates each module, and then interactively has the exoskeleton student user repeat and demonstrate specified knowledge, skills, and abilities to verify and validate the complete transfer of that knowledge, skills, and abilities.  
4.4 This practice by itself is not a training document. It is an outline of the topics required for training or evaluating exoskeleton users for competence, proficiency, certification, or license.  
4.5 The knowledge, skills, and abilities presented in the following sections are not in any particular order and do not represent a training sequence.
SCOPE
1.1 This practice establishes the minimum training requirements, including general knowledge, skills, and abilities, for personnel who use an exoskeleton as part of their duties.  
1.2 This practice applies only to exoskeletons and exosuits.  
Note 1: For more advanced exoskeletons, those that are powered, or with IT data connections/links for data transfer, or combinations thereof, upload/download requirements, ensure exoskeleton user and system operators training includes addressing all precautions so they can quickly identify and resolve any data transfer problems experienced with a fully operational exoskeleton.  
1.3 It is recognized that organizations and job responsibilities vary widely among military, medical, industrial, and emergency response communities. It is the responsibility of the user of this practice to identify the appropriate subject matter for its program and its specific needs.  
1.4 Users of this practice should consult with the exoskeleton manufacturer to ensure they have the latest and most relevant information on the exoskeleton. In addition, all training should comply with laws and regulations regarding user safety and health as well as the safety of individuals in close proximity to the user.  
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.