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
Current Stage
Ref Project

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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
1
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.
4
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
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
3
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 service@astm.org. 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
1

---------------------- Page: 1 ----------------------
F3358 − 20
used to supplement text on the product label(s) and should be 6.3.1 Proper care instructions, including maintenance, solu-
explained in the user documentation materials. tions for common issues or problems, cleaning, inspection
guidelines and frequency, recommended storage practices,
5.5 The label should include at least
...

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
1
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
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
3
2.2 U.S. Code of Federal Regulations:
21 CFR 890.3480 Powered lower extremity exoskeleton
4
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.
1
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.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://www.access.gpo.gov.
4
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
1

---------------------- Page: 1 ----------------------
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 permitted to be used
to supplement text on the product label(s) and should be explained in the user documentation materials.
1
5.5 The label should include at least the following information. All
...

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