ASTM F3527-21

Standard Guide for Assessing Risks Related to Implementation of Exoskeletons in Task-Specific Environments

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...

General Information

• Status: Published
• Publication Date: 31-Aug-2021
• ICS: 25.040.30 - Industrial robots. Manipulators
• Technical Committee: F48 - Exoskeletons and Exosuits
• Drafting Committee: F48.02 - Human Factors and Ergonomics

Relations

• Refers: ASTM F3444/F3444M-20 - Standard Practice for Training Exoskeleton Users
• Effective Date: 01-Jun-2020
• Refers: ASTM F3427-20 - Standard Practice for Documenting Environmental Conditions for Utilization with Exoskeleton Test Methods
• Effective Date: 01-Mar-2020
• Refers: ASTM F3323-19a - Standard Terminology for Exoskeletons and Exosuits
• Effective Date: 01-Oct-2019
• Refers: ASTM F3323-19 - Standard Terminology for Exoskeletons and Exosuits
• Effective Date: 01-Apr-2019
• Refers: ASTM F3323-18 - Standard Terminology for Exoskeletons and Exosuits
• Effective Date: 01-Sep-2018

Overview

ASTM F3527-21: Standard Guide for Assessing Risks Related to Implementation of Exoskeletons in Task-Specific Environments is an internationally recognized guide developed by ASTM International. This standard offers a structured approach to evaluating and managing risks associated with introducing exoskeleton technology in diverse occupational settings. As exoskeletons become more prevalent in workplaces-from warehouses to construction sites-this guide supports organizations in ensuring safety and effective implementation tailored to specific tasks and environments.

The standard focuses on acute and observable risks that may impact workers using occupational exoskeletons and provides a foundational process for organizations to identify, evaluate, and mitigate potential hazards. ASTM F3527-21 is applicable to employers implementing exoskeletons for paid workers in real-world work environments, emphasizing practical, contextual assessment rather than laboratory-only settings.

Key Topics

• Risk Assessment Process
  The guide outlines a step-by-step methodology for assessing the risks exoskeletons may pose when integrated into specific job roles. These steps include:

  • Identifying exoskeleton characteristics
  • Analyzing inherent risks
  • Breaking down tasks into task elements
  • Evaluating interaction risks between exoskeletons and job-specific tasks
  • Identifying harm scenarios and risk reduction needs
  • Ongoing risk monitoring and documentation

• Task-Specific Hazard Identification
  The standard stresses the importance of understanding the unique environment, job responsibilities, and tasks associated with each implementation. This includes:

  • Consideration of user characteristics, PPE, tools and machinery, environmental conditions, and more
  • Use of detailed harm scenario lists to anticipate potential risks

• Decision Support Tools
  A working document is provided to guide organizations through the process, supporting consistent recordkeeping and risk tracking throughout the lifecycle of exoskeleton use.

• Residual Risk & Risk Reduction
  The guide helps identify residual risks after initial control measures and encourage a “living document” approach-continuously updating the risk assessment as new data emerge or as working conditions change.

• Limitations
  ASTM F3527-21 is designed for acute and observable injuries or harm. It does not address risks resulting in chronic, cumulative, or long-term injuries, nor does it cover areas such as rehabilitation, data privacy, or financial risks.

Applications

• Workplace Safety Programs
  Employers, safety managers, and ergonomists can use this standard when introducing exoskeletons to support manual handling, repetitive lifting, or physically demanding job functions.

• Procurement and Product Selection
  Organizations can apply the guide during purchasing decisions, assessing technology fit for specific environments and highlighting any potential safety concerns before deployment.

• Training and Acclimatization
  Supports the development of training programs for workers, helping identify user groups potentially at risk and the need for customized training.

• Continuous Risk Monitoring
  Enables ongoing evaluation and proactive management of hazards as work conditions, exoskeleton features, or personnel responsibilities evolve.

• Stakeholder Communication
  Offers a structured framework for documentation and reporting, useful for communicating risks and mitigation strategies to management, operators, and regulatory bodies.

Related Standards

• ASTM F3323 - Terminology for Exoskeletons and Exosuits
• ASTM F3427 - Practice for Documenting Environmental Conditions for Utilization with Exoskeleton Test Methods
• ASTM F3444/F3444M - Practice for Training Exoskeleton Users
• EN 13921 - Personal Protective Equipment – Ergonomic Principles
• ISO/IEC Guide 51 - Safety Aspects – Guidelines for their Inclusion in Standards
• ISO 31000 - Risk Management – Guidelines
• ISO 14971 - Medical Devices – Application of Risk Management to Medical Devices

Keywords: exoskeleton risk assessment, occupational exoskeleton safety, wearable robotics implementation, task-specific environment, workplace hazard identification, risk reduction measures, ASTM F3527-21 compliance, industrial exoskeletons, ergonomics, user safety, harm scenarios, risk matrix, safety standards.

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:F3527 −21
Standard Guide for
Assessing Risks Related to Implementation of Exoskeletons
in Task-Specific Environments
This standard is issued under the fixed designation F3527; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 When implementing exoskeletons in real-world work
mendations issued by the World Trade Organization Technical
environments, exoskeleton interaction with various compo-
Barriers to Trade (TBT) Committee.
nents of a given task and its environment can generate a
number of risks. This guide provides guidance for conducting
2. Referenced Documents
contextual risk assessment.Aworking document is provided in
2.1 ASTM Standards:
Appendix X1 to allow initiation of the risk assessment process.
It can be used to describe tasks, break the tasks down into task F3323 Terminology for Exoskeletons and Exosuits
F3427 Practice for Documenting Environmental Conditions
elements, anticipate related harm scenarios (a series of typical
for Utilization with Exoskeleton Test Methods
harm scenarios are provided), assess related risks, and detect
F3444/F3444M Practice for Training Exoskeleton Users
scenarios that may require further analysis or implementation
of risk reduction measures.
2.2 Other Standards:
EN 13921 Personal Protective Equipment - Ergonomic Prin-
1.2 This guide applies to exoskeletons administered by
ciples
employers to paid workers or professionals to support work-
ISO/IEC Guide 51 Safety aspects — Guidelines for their
related tasks and activities.
inclusion in standards
1.3 This guide addresses risks that may result in acute and
ISO 31000 Risk Management — Guideline
observable injury and harm. This guide does not address the
ISO 14971 Medical Devices — Application of Risk Man-
following topics and concerns related to exoskeleton use:
agement to Medical Devices
1.3.1 Assessment and prevention of risk factors that can
lead to chronic, cumulative, or long-term injuries;
3. Terminology
1.3.2 Use of exoskeletons to support rehabilitation and
3.1 Many terms used within this guide are defined as in
return to work;
Terminology F3323 – 20. The following terms and definitions
1.3.3 Risks related to storage and use of personal informa-
are used within this guide and are not defined within Termi-
tion;
nology F3323 – 20.
1.3.4 Risks that may result in damage of objects; and
1.3.5 Financial risks.
3.2 Definitions:
3.2.1 harm, n—injury or damage to the health of people, or
1.4 Units—The values stated in SI units are to be regarded
damage to property or the environment. ISO/IEC Guide 51
as the standard. No other units of measurement are included in
this standard. 3.2.2 harm scenario, n—circumstance in which people,
property or the environment is/are exposed to one or more
1.5 This standard does not purport to address all of the
hazards.
safety concerns, if any, associated with its use. It is the
3.2.2.1 Discussion—Equivalentto“hazardoussituation”de-
responsibility of the user of this standard to establish appro-
fined in ISO/IEC Guide 51.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
dance with internationally recognized principles on standard-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
This guide is under the jurisdiction ofASTM Committee F48 on Exoskeletons the ASTM website.
and Exosuits and is the direct responsibility of Subcommittee F48.02 on Human Available from British Standards Institution (BSI), 389 Chiswick High Rd.,
Factors and Ergonomics. London W4 4AL, U.K., http://www.bsigroup.com.
Current edition approved Sept. 1, 2021. Published October 2021. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3527-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3527−21
3.2.3 implementer, n—natural or legal person responsible 3.2.14.2 Discussion—Opposite to unacceptable risk.
forpurchase,administrationand/orimplementationofexoskel-
4. Significance and Use
etons in task-specific environments.
3.2.3.1 Discussion—Legal person refers to a human or
4.1 There is evidence to support use of occupational exo-
non-human entity that is treated as a person for limited legal skeletons to support work tasks and activities. It is recognized
purposes.
that organizations, job responsibilities, and working contexts
vary widely. Additionally, a wide array of exoskeletons are
3.2.4 producer, n—natural or legal person with responsibil-
becoming available on the market. Exoskeletons vary in terms
ity for the design, manufacture, assembly, packaging, or
of complexity, form and mass, body coverage, and function.
labeling of an exoskeleton, or adapting an exoskeleton before
Certification programs for occupational exoskeletons are not
it is placed on the market or put into service, regardless of
available at this time. As such, at the present time no
whether these operations are carried out by that person or on
mechanisms exist to guarantee that circumstantial risk evalu-
that person’s behalf by a third party.
ation was performed on exoskeletons or whether these evalu-
3.2.4.1 Discussion—Legal person refers to a human or
ations reflect the real working context in which exoskeletons
non-human entity that is treated as a person for limited legal
will be implemented.
purposes.
4.2 This guide provides a minimum baseline for assessing
3.2.5 residual risk, n—risk remaining after risk reduction
risks that may arise from exoskeleton interaction with existing
measures have been implemented.
and task-specific environments. The working document pre-
Adapted from ISO/IEC Guide 51:2014
sented in Appendix X1 can be used to support decision making
3.2.6 risk, n—combination of the probability of occurrence
at different stages of exoskeleton implementation, such as:
of harm and the severity of that harm.
4.2.1 Purchase—It can highlight safety concerns that may
3.2.6.1 Discussion—The probability of occurrence includes
arise from introduction of a given exoskeleton technology in a
the exposure to a hazardous situation, the occurrence of a
specific work context;
hazardous event and the possibility to avoid or limit the harm
4.2.2 Implementation of Risk Reduction Measures—It can
(definition and discussion adapted from ISO/IEC Guide
highlight residual risks that require risk reduction measures;
51:2014).
4.2.3 Detection of Unknowns—It can lead to definition of
3.2.7 risk analysis, n—systematic use of available informa-
additional steps that are needed to satisfy risk assessment for
tion to identify hazards and to estimate the risk. potentially hazardous situations;
Adapted from ISO/IEC Guide 51:2014
4.2.4 Risk Monitoring—It can be used as a “living docu-
ment”tomonitorresidualrisksthroughouttheuseperiodofthe
3.2.8 risk assessment, n—overall process comprising a risk
exoskeleton.
analysis and a risk evaluation.
Adapted from ISO/IEC Guide 51:2014
4.3 Harm scenarios described in this guide primarily reflect
situations that may result in acute and observable injury or
3.2.9 risk evaluation, n—procedure based on the risk analy-
harm to a person. This guide is not suited for assessment of
sis to determine whether tolerable risk has been exceeded.
potential exoskeleton-to-task incompatibilities that may result
Adapted from ISO/IEC Guide 51:2014
in chronic, cumulative, or long-term injuries. However, these
3.2.10 risk reduction measure, n—action or means to elimi-
should be considered as part of any exoskeleton selection and
nate hazards or reduce risks.
implementation process. Guidelines on evaluation of risk
Adapted from ISO/IEC Guide 51:2014
factors that may lead to such injuries are currently under
3.2.10.1 Discussion—Equivalent to protective measure.
development and not yet published.
3.2.10.2 Discussion—Examples of risk reduction measures
4.4 The user of this guide should evaluate the applicability
are inherently safe design, protective devices, personal protec-
of this guide for the given job context. The tool provided in
tive equipment, information for use and installation, organiza-
Appendix X1 can be used as presented, can be adapted to
tion of work, training, application of equipment, and supervi-
reflect additional safety concerns, or elements of it can be used
sion.
to supplement risk assessment tools existing in the enterprise
3.2.11 safety, n—freedom from risk which is not tolerable.
where an exoskeleton is implemented.
Adapted from ISO/IEC Guide 51:2014
4.5 The questions, statements, and harm scenarios provided
3.2.12 task element, n—acomponentorconstituentofatask
in Appendix X1 are primarily targeted for assessment of risks
to describe a certain part or the entire entity of the task.
that may endanger primary exoskeleton users. These can be
3.2.12.1 Discussion—Equivalent to task component.
modified to assess risks that may endanger secondary users,
3.2.13 task-specific environment, n—the overall context in
such as maintenance personnel, trainers, adjustment personnel,
which a task is executed.
etc. It is recommended that risk assessment be conducted
3.2.13.1 Discussion—Equivalent to operating environment. separately for each user type.
3.2.14 tolerable risk, n—level of risk that is accepted in a
4.6 This guide can be used by non-specialized personnel to
given context based on the current values of society.
perform preliminary risk assessment, to aid, for example,
Adapted from ISO/IEC Guide 51:2014
pre-selection of exoskeleton models for purchase options.
3.2.14.1 Discussion—Equivalent to acceptable risk. However, prior to implementing an exoskeleton in real-world
F3527−21
working contexts, risk assessment should be conducted by are identified by means of task analysis (references for funda-
personnel having the knowledge and experience appropriate to mental notions of task analysis are provided in Appendix X5),
perform such assessment. This should include detailed knowl- and include:
edge of user tasks, ability to perform task analysis, knowledge 5.6.1.1 Essential Job Functions and Tasks—Which corre-
and experience with the particular exoskeleton model, and spond to the functions and tasks necessary to perform by the
knowledge of methods and of limitations associated to risk assigned position duties, such as manual handling of boxes in
analysis.As such, risk assessment may require involvement of a warehouse, transport of military equipment, laying bricks,
multiple stakeholders, including ergonomists and human fac- extinguishing fire with a firehose, and others.
tors specialists, users, managers, producer representatives, and 5.6.1.2 Non-essential Job Functions and Tasks—Which cor-
safety professionals. respond to accessory functions and tasks that may be unnec-
essary to perform the assigned position duties, such as walking
4.7 This guide does not supersede any established laws or
down a hallway, use of staircases, adopting sitting rest
regulations of international, national, federal, state, tribal,
postures, and others.
local, or regional governments.
5.6.1.3 Exoskeleton Specific Tasks—Correspond to tasks
related to general use, set up, and maintenance of the exoskel-
5. Procedure
eton. These can include and are not limited to the following:
5.1 Appendix X1 provides a series of questions and harm
retrieval from and disposal to storage, transport, assembly/
scenarios that can support initiation of the risk assessment
disassembly, structural inspection, donning and doffing, and
process related to exoskeleton interaction with the user’s task-
selecting modes of operation.
specific environment. Additional blank forms are provided in
5.7 Break Down into Task Elements:
Appendix X2, Appendix X3, and Appendix X4. The initiation
5.7.1 These sections are used to describe operating environ-
of the risk assessment process relies on the following steps: (1)
ments and task requirements.
identify exoskeleton characteristics, (2) assess inherent risks
5.7.2 Task elements should be captured for essential and
related to the exoskeleton, (3) identify tasks and break down
non-essential tasks executed with the exoskeleton, as well as
tasks into task elements, (4) assess risks resulting from the
for exoskeleton-specific tasks.
interaction of the exoskeleton with task elements, (5) detect
5.7.3 Task elements are determined by means of task
harm scenarios that require additional analysis, and (6) detect
analysis (refer to Appendix X5), and include:
harm scenarios that require implementation of risk reduction
5.7.3.1 Personal characteristics of the user population,
measures.
5.7.3.2 Clothing and personal protective equipment,
5.2 The process and applicable sections provided in Appen-
5.7.3.3 Machinery and equipment,
dix X1 – Appendix X4 are illustrated in Fig. 1.
5.7.3.4 Environment,
5.7.3.5 Handled and manipulated materials and objects,
5.3 Introductory Information:
5.7.3.6 Policies and procedures,
5.3.1 This section is used to record the following informa-
5.7.3.7 Social interaction,
tion: the date or period of assessment, the personnel who
5.7.3.8 Physical requirements,
conducted the assessment (“assessors”), the exoskeleton make,
5.7.3.9 Sensing requirements, and
model, and serial number, brief description of the exoskeleton
5.7.3.10 Mental and cognitive requirements.
user, and brief description of assessment results.
5.7.4 It is recommended that all listed task elements are
5.4 Exoskeleton Description:
carefully considered. The format of the tables can be modified
5.4.1 Thissectionisusedtoidentifyrelevantinformationon
and supplemented with additional items to reflect the user’s
the exoskeleton considered for implementation. Users of this
operatingenvironmentandtaskrequirements.Ablankformfor
guide should consult with the exoskeleton producer to ensure
additional task elements is presented in Appendix X2.
they have the latest and most relevant information on the
5.7.5 Task elements may also be captured in the existing job
exoskeleton, including its safety features, residual risks (for
assessment documentation (also known as job demands analy-
example, warnings), and recommended risk reduction mea-
sis and job analysis). In the case of existent job analysis
sures.
documentation, the relevant information can be copied to or
5.5 Harm Scenarios Inherent to Exoskeleton: referred to in the applicable sections.
5.5.1 This section provides a series of possible harm sce-
5.8 Harm Scenarios Related to Exoskeleton Interaction with
narios. It is used to detect and assess risks that may arise from
Task Elements:
exoskeleton use independently of a specific use context or
5.8.1 These sections are used to:
interaction with specific task elements. These include harm
5.8.1.1 Detect potential harm scenarios based on task analy-
scenarios that may arise from exoskeleton characteristics, such
sis which takes into consideration the addition of the exoskel-
as release of hazardous media, uncertified electric components,
eton in this context; and
damaged wiring, absence of emergency stop functions, etc.
5.8.1.2 Assess risks related to harm scenarios.
5.6 User Job Function and Tasks:
5.8.2 Harm scenarios presented in these sections address
5.6.1 These sections are used to list the user’s job functions concerns related to a wide range of possible exoskeleton
and tasks, and to anticipate tasks that would be executed in technologies and applications.As such, not all may be relevant
interaction with the exoskeleton. User job functions and tasks to the implementation context. It is recommended that all harm
F3527−21
FIG. 1Structure of the Working Document for Assessing Risks Related to Implementation of Exoskeletons
in Task-Specific Environments
scenarios provided in these sections be considered for initial 5.8.3 Risk assessment should be supported by an estab-
risk assessment. Unrelated harm scenarios may be omitted lished risk matrix. Guidelines for defining a risk matrix are
when a high confidence level is attained and is indicative of provided in Section 6.
their irrelevance to the given exoskeleton technology and 5.8.4 Risks related to harm scenarios should be assessed for
working context. Additional harm scenarios that reflect the essential and non-essential tasks executed with the
implementation context should be included as necessary. A exoskeleton, as well as for exoskeleton-specific tasks.
blank form for additional harm scenarios is presented in 5.8.5 Whileanumberofriskscanbeanticipated,analysisof
Appendix X3. some risks may require considerable effort, including and not
F3527−21
limited to tests, simulations, and biomechanical analysis. task, or other pertinent elements. It also implies consideration
Standard test methods to support risk analysis are being of exoskeleton weight supported on body segments and any
developed and are not yet published. Furthermore, caution is assistance provided by the exoskeleton to the various articula-
advised when assessing risks based on assumptions. Freedom tions. Blank forms in Appendix X2 and Appendix X3 can be
from unacceptable risk should be supported and validated by used to describe relations of “Task Elements” and to detail
simulations, limited field trials, and longitudinal field trials. harm scenarios.
5.10.2.1 Certainrisksmaynotbeidentifiedintheinitialrisk
5.9 Risk Reduction Measures:
assessmentstage,andbecomeapparentonlyduringtherealuse
5.9.1 Risk reduction measures should be identified and
oftheexoskeleton.Additionally,effectivenessofriskreduction
described for all harm scenarios that present a medium to high
measures should be validated prior to and monitored during
level of risk, or as defined in the supporting “risk matrix” and
real-world use of exoskeleton. It is, therefore, good practice to
“risk levels and required action” used by the assessor(s). Risk
maintain and update risk assessment documentation after
reduction measures can include and are not limited to the
exoskeleton implementation.
following: restrict the use of exoskeletons only for tasks or
activities that are assessed as free of unacceptable risk, provide
6. Risk Matrix
special training, define procedures that decrease risks to
acceptable levels, modify and adapt task elements to exoskel-
6.1 A risk matrix, including definitions for severity,
eton use.
probability, as well as definitions for risk levels, are provided
5.9.2 Appendix X1 includes two “risk reduction measures”
as examples in Table 1 and Table 2. They can be adapted and
sections that provide guidance to mitigate risks related to
modified as relevant and necessary for the implementation
exoskeleton interaction with the personal characteristics of the
context. If adaptation or modification is required, safety of the
user population:
exoskeleton user and of persons interacting directly or indi-
5.9.2.1 TableX1.8:Proceduretoidentifyusersincompatible
rectly with the user should be maintained as the primary goal.
with exoskeleton, and
5.9.2.2 Table X1.9: Exoskeleton training.
7. Precision and Bias
5.9.2.3 These sections apply to any exoskeleton technology
7.1 The precision of risk assessment depends on the knowl-
and application sector and should be addressed prior to
edge and experience of assessors as well as on the quality of
exoskeleton implementation.
data used for assessment. Furthermore, estimation of risk
5.9.3 Riskreductionmeasuresrequiredtomitigaterisksthat
magnitude cannot be measured directly, and frequently re-
arise from other exoskeleton-to-task elements interactions can
quires use of assumptions. For this reason, it is recommended
be described in Appendix X4 or in a separate document.
that absence of unreasonable risk be validated continuously, by
5.10 Additional Guidance:
progressively implementing the exoskeleton in complex real-
5.10.1 Some risks can be identified as they relate to a single
world environments and monitoring potential harm scenarios
class of “task elements,” such as an exoskeleton that prevents
after adoption of the exoskeleton for a job position.
the use of the fall arrest harness, related to the task element
7.2 The users of this guide should be aware of the limits of
“clothing and PPE.”
risk assessment, and that not all risk can be anticipated or
5.10.2 Risks may also arise from interaction of several
eliminated for all use cases.
“Task Elements” with an exoskeleton. For example, to assess
whethertheexoskeletonmaycauseacuteandobservableinjury
8. Keywords
during a manual handling task, a more holistic analysis is
typically required. That can include recording combinations of 8.1 accident; environment; exoskeleton; hazard; implemen-
several task elements, such as the weight of handled objects tation; incident; injury; risk assessment; safety; task; use
and the posture that the user needs to adopt to complete the context; wearable robotics
A
TABLE 1 Risk Matrix
Severity
Minor Moderate Significant
Slight injury, that can be treated Reversible injury which requires Permanent injury or injury resulting
with first aid medical treatment in death
(more than first aid)
High
Likely to happen, often, Medium risk High risk Very high risk
frequently
Medium
Low risk High risk High risk
Can happen but not frequently
Low
Unlikely to happen, rare, Very low risk Low risk Medium risk
remote
A
Additional information on risk matrix definition can be found in the following references:
ISO 31000 – Risk Management – Guideline
ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices
Probability
F3527−21
TABLE 2 Risk Levels and Required Action
Risk Very low Low Medium High Very high
level
Action No immediate action is It is recommended to redesign to remove
recommended, but hazard, or control with appropriate
improve when feasible safeguards with a priority given to higher
level risks
APPENDIXES
(Nonmandatory Information)
X1. WORKING DOCUMENT FOR ASSESSING RISKS RELATED TO IMPLEMENTATION OF EXOSKELETONS
IN TASK-SPECIFIC ENVIRONMENTS
X1.1 See Tables X1.1-X1.27.
F3527−21
TABLE X1.1 Introductory Information
DATE/PERIOD:
ASSESSOR(S):
EXOSKELETON Make
Model
Serial number
USER Company ⁄Agency ⁄Institution
Department ⁄Branch
Job title
SUMMARY RESULTS
F3527−21
TABLE X1.2 Exoskeleton Description
NOTE 1—Provide relevant description of the exoskeleton, based on information provided by the producer. Contact producer for missing information.
1. Exoskeleton: Make
Model
Serial Number
2. Body coverage: Full Body
Upper Extremity
Lower Extremity
Torso
Cervical
Other, specify
3. Weight (kg):
4. Actuation: Electric, specify power source (ex: lithium-ion batteries):
Pneumatic
Hydraulic
Spring
No actuation
Other, specify
5. Is the exoskeleton certified? Yes, enumerate certifications:
No
6. Was this exoskeleton model previously assessed for safety for this Yes, specify documentation related to the assessment
job position in the context of this company?
No
Unknown
7. Was this exoskeleton model previously assessed for safety for Yes, specify documentation related to the assessment
related job positions in the context of this or another company?
No
Unknown
8. Does the exoskeleton release oil or gases? Yes, specify:
No
9. Does the exoskeleton contain media under pressure Yes, specify:
(ex: oil, gases)?
No
10. Does the exoskeleton contain hazardous substances? Yes, specify:
No
11. Does the exoskeleton contain easily flammable substances Yes, specify:
(solids/liquids)?
No
12. Does the exoskeleton exhibit surfaces likely to become habitats Yes, specify areas:
for living organisms (fungi, germs, bacteria, mold)?
No
13. Can explosive mixtures arise from the exoskeleton? Yes, specify:
No
14. Does the exoskeleton require wireless connectivity? Yes, specify:
No
15. Does the exoskeleton emanate radiation? Yes, specify:
Types of radiation include and are not limited to the following: nuclear,
ultraviolet (UV), visible light, infrared (IR), microwave (MW), radio No
frequency (RF), extremely low frequency (ELF), particle (Alpha, Beta,
Proton, and Neutron), magnetic fields and electric fields.
16. Does the exoskeleton have an onboard emergency stop function Yes, specify location and trigger (ex: button on chest):
that can be initiated by the user?
No
17. Does the exoskeleton have an emergency stop function that can Yes, tethered
be remotely initiated? Yes, wireless
No
18. Does the exoskeleton have emergency doffing features? Yes, specify:
No
19. Can the exoskeleton be removed by another person if the user Yes
becomes incapacitated? No
20. Does safe use of the exoskeleton require supervision? Yes, specify:
No
F3527−21
TABLEX1.2 Continued
21. Check boxes of specific adjustments required for safe use of the h Size adjustments
exoskeleton h Actuator adjustments
h Software adjustments
h Other, specify:
TABLE X1.3 Harm Scenarios Inherent to Exoskeleton
NOTE 1—Using the harm scenarios listed below and the information provided by the manufacturer, analyze and evaluate the inherent risks related to
the use of exoskeleton. Verify hazards and warnings provided by the manufacturer to include respective risks. For severity, probability, and risk level
determination, refer to Section 6 of this guide or any adapted risk matrix. Check boxes “control needed” for risks requiring risk reduction measures.
Harm Scenario Severity Probability Risk Level Control Needed
1. Exoskeleton can release media (oils, gases) that can poison or injure the h
user
2. Exoskeleton can release media under pressure that can cause burns and h
injuries
3. Exoskeleton employs tanks that can burst h
4. Exoskeleton exhibits mechanical failure hazards that may result in risk of in- h
jury
Unsecured or loose nuts h
Damaged frame components h
Damaged elastic or spring components h
5. Exoskeleton exhibits electric hazards that may result in risk of injury
Damaged wiring insulation h
Damaged equipment enclosures h
Faulty plugs and sockets h
Unsafe electrical equipment h
6. Exoskeleton exhibits engineering uncertainties that present an inherent risk:
Uncertified electrical equipment h
Uncertified hydraulic mechanism h
Uncertified or no onboard emergency stop function h
Uncertified or no remote emergency stop function h
7. Exoskeleton contains hazardous substances that can poison or injure the h
user
8. Triggering of the emergency stop function may require the user to h
support an excessive weight and cause falling or musculoskeletal injury
9. Triggering of the emergency stop function may block exoskeleton h
articulations and cause falling or musculoskeletal injury
10. Improper or no implementation of procedures may cause an unsafe set-up
and state of the exoskeleton
Size adjustment h
Actuation adjustment h
Software adjustment h
Maintenance and inspection h
Cleaning h
Storage h
Transportation h
Supervision h
Training h
11. Additional inherent harm scenarios:
h
h
h
h
h
F3527−21
TABLE X1.4 User Job Function and Tasks
NOTE 1—Copy these from or refer to the Job Analyses document if available.
Company/Agency/Institution:
Department/Branch:
Job title:
User type: Primary User
Secondary User, specify: (ex: exoskeleton maintenance personnel/training personnel)
Summary Description of the User’s Job Functions and
Tasks:
Work shift(s):
TABLE X1.5 User Job Function and Tasks (continued)
F3527−21
TABLE X1.6 Task Elements - User Population Personal Characteristics
NOTE 1—Provide relevant description of the user population.
Age: Between _____ and ______
Gender: Female
Male
Other
Anthropometric characteristics of the user population:
Height: Between_____ and ______
Weight: Between_____ and ______
If applicable, other critical measurements of the user population identified by the producer (ex: waist circumference, shoe size, etc.):
1. Between_____ and ______
2. Between_____ and ______
3. Between_____ and ______
4. Between_____ and ______
5. Between_____ and ______
6. Between_____ and ______
If applicable, resting vital signs, Functional Outcome Measures or other relevant metrics of the user population (ex: resting heart rate, VO2 max, time to complete a
task, etc.):
1. Between_____ and ______
2. Between_____ and ______
3. Between_____ and ______
4. Between_____ and ______
5. Between_____ and ______
6. Between_____ and ______
Do the users suffer from musculoskeletal injuries, No
respiratory, circulatory, or other physical Yes, enumerate the injuries and disorders
disorders?
Unknown
Do the users suffer from mental or neurologic dis- No
orders? Yes, enumerate the neurological disorders
Unknown
Do the users suffer from allergies? No
Yes, enumerate the allergies
Unknown
Do the users have electrical implantable devices No
(ex: pacemaker, implantable cardiac defibrillator, Yes,
...