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 F3427-20 - Standard Practice for Documenting Environmental Conditions for Utilization with Exoskeleton Test Methods
• Effective Date: 01-Mar-2020
• Refers: ASTM F3444/F3444M-20 - Standard Practice for Training Exoskeleton Users
• Effective Date: 01-Jun-2020

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
1
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
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
3
ciples
employers to paid workers or professionals to support work-
ISO/IEC Guide 51 Safety aspects — Guidelines for their
related tasks and activities.
4
inclusion in standards
1.3 This guide addresses risks that may result in acute and
4
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:
4
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-
2
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
1
This guide is under the jurisdiction ofASTM Committee F48 on Exoskeletons the ASTM website.
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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.
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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
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F3527−21
3.2.3 implementer, n—natural or legal person responsible 3.2.14.2 Discussion—Opposite to unaccep
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