ASTM F3540-21
(Guide)Standard Guide for Hazards for Consideration when Designing Exoskeletons
Standard Guide for Hazards for Consideration when Designing Exoskeletons
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.
General Information
Relations
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: F3540 − 21
Standard Guide for
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Hazards for Consideration when Designing Exoskeletons
This standard is issued under the fixed designation F3540; 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 F2808 Test Method for Performing Behind-the-Knee (BTK)
Test for Evaluating Skin Irritation Response to Products
1.1 This guide lists typical hazards that should be consid-
and Materials That Come Into Repeated or Extended
ered by exoskeleton producers when analyzing and managing
Contact with Skin
potential risks related to exoskeletons.
F3323 Terminology for Exoskeletons and Exosuits
1.2 Where possible, this guide provides references to
F3392 Practice for Exoskeleton Wearing, Care, and Mainte-
agency standards, regulations, or guidelines for assessment of
nance Instructions
risks related to these hazards and for application of risk
F3427 Practice for Documenting Environmental Conditions
reduction measures.
for Utilization with Exoskeleton Test Methods
F3474 Practice for Establishing Exoskeleton Functional Er-
1.3 Thisguideappliestoallexoskeletontypes,regardlessof
theapplicationsofthetechnologysuchasconsumer,industrial, gonomic Parameters and Test Metrics
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2.2 ANSI Standards:
medical, military, and emergency management services.
ANSI/ASA S2.70 Guide for the Measurement and Evalua-
1.4 Units—The values stated in SI units are to be regarded
tion of Human Exposure to Vibration Transmitted to the
as standard. No other units of measurement are included in this
Hand
standard.
ANSI C18.2M Part 2 American National Standard for Por-
1.5 This standard does not purport to address all of the
table Nickel Rechargeable Cells and Batteries – Safety
safety concerns, if any, associated with its use. It is the
Standard
responsibility of the user of this standard to establish appro-
ANSI C63.4-2014 American National Standard for Methods
priate safety, health, and environmental practices and deter-
of Measurement of Radio-Noise Emissions from Low-
mine the applicability of regulatory limitations prior to use.
Voltage Electrical and Electronic Equipment in the Range
1.6 This international standard was developed in accor-
of 9 kHz to 40 GHz
dance with internationally recognized principles on standard-
ANSI Z535.4 Product Safety Signs and Labels
ization established in the Decision on Principles for the 4
2.3 BSI Standards:
Development of International Standards, Guides and Recom-
BS EN 13921 Personal protective equipment. Ergonomic
mendations issued by the World Trade Organization Technical
principles
Barriers to Trade (TBT) Committee.
EN 50581:2012 Technical documentation for the assessment
of electrical and electronic products with respect to the
2. Referenced Documents
restriction of hazardous substances
2
2.1 ASTM Standards: 5
2.4 CEN Standards:
C1055 Guide for Heated System Surface Conditions that
CR 1030-1 Hand-arm Vibration – Guidelines for Vibration
Produce Contact Burn Injuries
Hazards Reduction – Part 1: Engineering Methods by
C1057 Practice for Determination of Skin Contact Tempera-
Design of Machinery
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ture from Heated Surfaces Using a Mathematical Model
2.5 IEC Standards:
and Thermesthesiometer
IEC 60529 Degrees of protection provided by enclosures (IP
D1230 Test Method for Flammability of Apparel Textiles
Code)
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This guide is under the jurisdiction ofASTM Committee F48 on Exoskeletons Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
and Exosuits and is the direct responsibility of Subcommittee F48.02 on Human 4th Floor, New York, NY 10036, http://www.ansi.org.
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Factors and Ergonomics. Available from British Standards Institution (BSI), 389 Chiswick High Rd.,
Current edition approved Nov. 1, 2021. Published November 2021. DOI: London W4 4AL, U.K., http://www.bsigroup.com.
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10.1520/F3540-21. Available from European Committee for Standardization (CEN), Avenue
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Marnix 17, B-1000, Brussels, Belgium, http://www.cen.eu.
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from International Electrotechnical Commission (IEC), 3, rue de
Standards volume information, refer to the standard’s Document Summary page on Varembé, 1st floor, P.O. Box 131, CH-1211, Geneva 20, Switzerland, https://
the ASTM website. www.iec.ch.
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