ASTM F3358-20

Standard Practice for Labeling and Information for Exoskeletons

SIGNIFICANCE AND USE
4.1 This practice contains the recommendations for minimal informational requirements for the identification of exoskeletons. It is intended to provide the user with some of the basic information necessary for the selection and use of the exoskeletons.  
4.2 Additional information beyond the content recommended by this practice is permitted to be applied to the label.
SCOPE
1.1 This practice sets forth labeling and instruction guidelines for manufacturers of exoskeletons.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.  
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.

General Information

• Status: Published
• Publication Date: 31-Aug-2020
• ICS: 11.180.10 - Aids and adaptation for moving
• ICS: 25.040.30 - Industrial robots. Manipulators
• Technical Committee: F48 - Exoskeletons and Exosuits
• Drafting Committee: F48.01 - Design and Manufacturing

Relations

• Refers: ASTM F1301-18(2024)e1 - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 01-Feb-2024
• Refers: ASTM F2727-09(2020) - Standard Guide for Manufacturers for Labeling Headgear Products
• Effective Date: 01-Apr-2020
• Refers: ASTM F1301-18 - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 01-Jan-2018
• Refers: ASTM F1301-17 - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 01-Nov-2017
• Refers: ASTM F2727-09(2014) - Standard Guide for Manufacturers for Labeling Headgear Products
• Effective Date: 01-Nov-2014
• Refers: ASTM F1301-90(2011)e1 - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 01-Feb-2011
• Refers: ASTM F2727-09 - Standard Guide for Manufacturers for Labeling Headgear Products
• Effective Date: 01-Jan-2009
• Refers: ASTM F1301-90(2006) - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 01-Jun-2006
• Refers: ASTM F1301-90(2001) - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 12-Sep-1990
• Refers: ASTM F1301-90(1996)e2 - Standard Practice for Labeling Chemical Protective Clothing
• Effective Date: 12-Sep-1990

Overview

ASTM F3358-20: Standard Practice for Labeling and Information for Exoskeletons provides clear recommendations on the minimal information required for the labeling and accompanying literature of exoskeletons. Developed by ASTM International, this practice establishes essential content for manufacturers when labeling wearable robotics, ensuring products are clearly identified and providing guidance to end users for selection and safe operation. The standard applies to both powered and unpowered exoskeletons, with an emphasis on providing reliable information for professional, consumer, and medical devices.

Key Topics

• Labeling Requirements:

  • Every exoskeleton must have a visible, permanent label.
  • The label should include the manufacturer’s name, product identification (model or serial number), lot number, and date of manufacture.
  • Warning statements, cautions, limitations, and relevant safety information must be present.
  • Labels may also include certification marks and graphical symbols, explained in user materials.

• Accompanying Literature:

  • Manufacturers must provide comprehensive instructions, either printed, electronic, or available online.
  • Content should cover setup, fitting, user adjustment, safe operation, care and maintenance, troubleshooting, and warranty support.
  • Clear guidance must also be provided for reporting adverse events.

• Graphics & Symbols:

  • Supplementary use of ISO 7000 and IEC 60417 graphical symbols is permitted for clarity, especially to support language accessibility.

• Language and Accessibility:

  • Labels and accompanying documentation must be presented in a language understandable by intended users.

• Regulatory and Safety Compliance:

  • The standard does not address all regulatory requirements or safety concerns; users must determine any additional legal or safety obligations based on the intended use and jurisdiction.

Applications

ASTM F3358-20 is critical for manufacturers, designers, and distributors of exoskeletons and wearable robotics, ensuring products are delivered with clear, accurate, and standardized labeling. Key application areas include:

• Manufacturing and Production:

  • Standardized labeling supports traceability, quality assurance, and after-sale support.
  • Clear documentation facilitates compliance with international market requirements.

• Medical and Rehabilitation Use:

  • Detailed instructions enhance user safety, especially in clinical or rehabilitation settings.
  • Supports regulatory approval processes for medical devices.

• Industrial and Consumer Products:

  • Ensures end users receive vital usage, safety, and maintenance information, reducing the risk of misuse or accidents.
  • Facilitates integration into workplace ergonomics and safety programs.

• Product Support and Service:

  • Readily-available support contacts and warranty information improve user confidence and enable effective aftercare.

Related Standards

ASTM F3358-20 references and aligns with several international regulations and standards to provide a comprehensive approach for exoskeleton labeling and user instructions:

• ASTM F3392: Practice for Exoskeleton Wearing, Care, and Maintenance Instructions
• ASTM F1301: Practice for Labeling Chemical Protective Clothing
• ASTM F2727: Guide for Manufacturers for Labeling Headgear Products
• 21 CFR 890.3480: U.S. Code of Federal Regulations for Powered Lower Extremity Exoskeletons
• ISO 7000 / IEC 60417: Graphical Symbols for Use on Equipment

Manufacturers and stakeholders should consult these standards and applicable regional regulations to ensure full compliance and optimum user safety.

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Keywords: exoskeleton labeling, wearable robotics, ASTM F3358-20, product identification, safety instructions, manufacturer guidelines, international standards, exoskeleton user documentation

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: F3358 − 20
Standard Practice for
Labeling and Information for Exoskeletons
This standard is issued under the fixed designation F3358; 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 2.3 Other Standards:
ISO 7000 / IEC 60417 Graphical symbols for use on
1.1 This practice sets forth labeling and instruction guide-
equipment
lines for manufacturers of exoskeletons.
1.2 The values stated in SI units are to be regarded as 3. Terminology
standard. The values given in parentheses are mathematical
3.1 Definitions:
conversions to inch-pound units that are provided for informa-
3.1.1 accompanying literature, n—printed material or elec-
tion only and are not considered standard.
tronic records that accompanies the product when it is sold or
1.3 This standard does not purport to address all of the
distributed.
safety concerns, if any, associated with its use. It is the
3.1.2 contact information, n—information that allows a user
responsibility of the user of this standard to establish appro-
to contact the manufacturer of the product, such as name,
priate safety, health, and environmental practices and deter-
telephone number, and website address.
mine the applicability of regulatory limitations prior to use.
3.1.3 date of manufacture, n—uncoded month and four-digit
1.4 This international standard was developed in accor-
year during which the exoskeleton was manufactured.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4. Significance and Use
Development of International Standards, Guides and Recom-
4.1 This practice contains the recommendations for minimal
mendations issued by the World Trade Organization Technical
informational requirements for the identification of exoskel-
Barriers to Trade (TBT) Committee.
etons. It is intended to provide the user with some of the basic
information necessary for the selection and use of the exoskel-
2. Referenced Documents
etons.
2.1 ASTM Standards:
4.2 Additional information beyond the content recom-
F2727 Guide for Manufacturers for Labeling Headgear
mended by this practice is permitted to be applied to the label.
Products
F1301 Practice for Labeling Chemical Protective Clothing
5. Labeling Recommendations
F3392 Practice for Exoskeleton Wearing, Care, and Mainte-
5.1 Each exoskeleton should have a product label perma-
nance Instructions
nently and visibly attached, stamped, or printed.
2.2 U.S. Code of Federal Regulations:
21 CFR 890.3480 Powered lower extremity exoskeleton
5.2 Multiple label pieces should be permitted in order to
carry all statements and information on the product label.
1 Instructional manuals and promotional material are not consid-
This practice is under the jurisdiction of ASTM Committee F48 on Exoskel-
etons and Exosuits and is the direct responsibility of Subcommittee F48.01 on ered part of the label.
Design and Manufacturing.
5.3 All label text should be written at least in a language
Current edition approved Sept. 1, 2020. Published September 2020. Originally
approved in 2018. Last previous edition approved in 2018 as F3358 – 18. DOI: which the intended users can understand.
10.1520/F3358-20.
2 5.4 Symbols and other graphical information, such as ISO
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 7000 / IEC 60417 graphical symbols, should be permitted to be
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available from U.S. Government Printing Office, Superintendent of Available from International Organization for Standardization (ISO), ISO
Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:// Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
www.access.gpo.gov. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
---------------
...

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: F3358 − 18 F3358 − 20
Standard Practice for
Labeling and Information for Exoskeletons
This standard is issued under the fixed designation F3358; 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 practice sets forth labeling and instruction guidelines for manufacturers of exoskeletons.
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to
inch-pound units that are provided for information only and are not considered standard.
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.
2. Referenced Documents
2.1 ASTM Standards:
F2727 Guide for Manufacturers for Labeling Headgear Products
F1301 Practice for Labeling Chemical Protective Clothing
F3392 Practice for Exoskeleton Wearing, Care, and Maintenance Instructions
2.2 U.S. Code of Federal Regulations:
21 CFR 890.3480 Powered lower extremity exoskeleton
2.3 Other Standards:
ISO 7000 / IEC 60417 Graphical symbols for use on equipment
3. Terminology
3.1 Definitions:
3.1.1 accompanying literature, n—printed material or electronic records that accompanies the product when it is sold or
distributed.
This practice is under the jurisdiction of ASTM Committee F48 on Exoskeletons and Exosuits and is the direct responsibility of Subcommittee F48.01 on Design and
Manufacturing.
Current edition approved Dec. 1, 2018Sept. 1, 2020. Published December 2018September 2020. Originally approved in 2018. Last previous edition approved in 2018 as
F3358 – 18. DOI: 10.1520/F3358-18.10.1520/F3358-20.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://www.access.gpo.gov.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3358 − 20
3.1.2 contact information, n—information that allows a user to contact the manufacturer of the product, such as name, telephone
number, and website address.
3.1.3 date of manufacture, n—uncoded month and four-digit year during which the exoskeleton was manufactured.
4. Significance and Use
4.1 This practice contains the recommendations for minimal informational requirements for the identification of exoskeletons. It
is intended to provide the user with some of the basic information necessary for the selection and use of the exoskeletons.
4.2 Additional information beyond the content recommended by this practice is permitted to be applied to the label.
5. Labeling Recommendations
5.1 Each exoskeleton should have a product label permanently and visibly attached, stamped, or printed.
5.2 Multiple label pieces should be permitted in order to carry all statements and information on the product label. Instructional
manuals and promotional material are not considered part of the label.
5.3 All label text should be written at least in a language which the intended users can understand.
5.4 Symbols and other graphical information, such as ISO 7000 / IEC 60417 graphical symbols, should be permi
...