ASTM F3358-2018 Standard Practice for Labeling and Information for Exoskeletons.pdf

1、Designation: F3358 18Standard Practice forLabeling and Information for Exoskeletons1This standard is issued under the fixed designation F3358; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in p

2、arentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice sets forth labeling and instruction guide-lines for manufacturers of exoskeletons.1.2 The values stated in SI units are to be regard

3、ed asstandard. The values given in parentheses are mathematicalconversions to inch-pound units that are provided for informa-tion only and are not considered standard.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of

4、the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization establis

5、hed in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F2727 Guide for Manufacturers for Labeling HeadgearProductsF1301 P

6、ractice for Labeling Chemical Protective Clothing2.2 U.S. Code of Federal Regulations:321 CFR 890.3480 Powered lower extremity exoskeleton2.3 Other Standards:4ISO 7000 / IEC 60417 Graphical symbols for use onequipment3. Terminology3.1 Definitions:3.1.1 accompanying literature, nprinted material or e

7、lec-tronic records that accompanies the product when it is sold ordistributed.3.1.2 contact information, ninformation that allows a userto contact the manufacturer of the product, such as name,telephone number, and website address.3.1.3 date of manufacture, nuncoded month and four-digityear during w

8、hich the exoskeleton was manufactured.4. Significance and Use4.1 This practice contains the recommendations for minimalinformational requirements for the identification of exoskel-etons. It is intended to provide the user with some of the basicinformation necessary for the selection and use of the e

9、xoskel-etons.4.2 Additional information beyond the content recom-mended by this practice is permitted to be applied to the label.5. Labeling Recommendations5.1 Each exoskeleton should have a product label perma-nently and visibly attached, stamped, or printed.5.2 Multiple label pieces should be perm

10、itted in order tocarry all statements and information on the product label.Instructional manuals and promotional material are not consid-ered part of the label.5.3 All label text should be written at least in a languagewhich the intended users can understand.5.4 Symbols and other graphical informati

11、on, such as ISO7000 / IEC 60417 graphical symbols, should be permitted to beused to supplement text on the product label(s) and should beexplained in the user documentation materials.5.5 The label should include at least the following informa-tion. All letters should be at least 2 mm (116 in.) high:

12、5.5.1 Manufacturers name, identification, or designation.5.5.2 Model, style, or serial number, or combinationsthereof.5.5.3 Lot number or designation may be incorporated inthe serial number.5.5.4 Date of manufacture uncoded month and year.1This practice is under the jurisdiction of ASTM Committee F4

13、8 on Exoskel-etons and Exosuits and is the direct responsibility of Subcommittee F48.01 onDesign and Manufacturing.Current edition approved Dec. 1, 2018. Published December 2018. DOI:10.1520/F3358-18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Servic

14、e at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from U.S. Government Printing Office, Superintendent ofDocuments, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.4Availab

15、le from International Organization for Standardization (ISO), ISOCentral 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 StatesThis int

16、ernational standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) C

17、ommittee.15.5.5 Warnings, cautions, limitations, precautions, notes,contraindications, and information related to the necessarysafeguards of the device, including warning against activitiesand environments that may put the user at greater risk. Detailedinformation regarding hazards and how to avoid

18、them shouldbe included in the information package.5.6 If applicable, the certification organizations label,symbol, or identifying mark should be legibly printed on theproduct label. All letters should be at least 2.5 mm (332 in.)high.6. Accompanying Literature Recommendations6.1 The manufacturer sho

19、uld provide an information pack-age in print, electronic media, through the use of an accessibleonline site, or any combination thereof, with each individualexoskeleton.6.2 The manufacturer should package the information withthe exoskeleton in such a manner that its inclusion is readilyapparent to t

20、he individual opening the package.6.3 The information package should include specific in-structions and the training needed for the safe use of theexoskeleton which includes, but is not limited to:6.3.1 Proper care instructions, including maintenance, solu-tions for common issues or problems, cleani

21、ng, inspectionguidelines and frequency, recommended storage practices,repair methods, and disposal where applicable,6.3.2 Complete instructions on the setup or fitting, or both,of the exoskeleton,6.3.3 Instructions on fitting the user and adjustmentprocedures,6.3.4 Instructions for operating the use

22、r interface of theexoskeleton,6.3.5 Instructions and explanation of all displays, controls,inputs, and outputs,6.3.6 Instructions on system operation of the exoskeleton,6.3.7 Instructions on all safety features of the exoskeleton,6.3.8 Point(s) of contact information for product and war-ranty suppor

23、t, and6.3.9 Information on how to report adverse events to manu-facturers and regulators as applicable.6.4 The manufacturer should maintain technical documen-tation for the exoskeleton to include:6.4.1 Information on the intended user population,6.4.2 Available options, accessories and sizes,6.4.3 I

24、nformation on electrical and thermal safety,6.4.4 Information on electromagnetic compatibility,6.4.5 Information on battery safety and performance,6.4.6 Information on durability (for example, cycleloading), and6.4.7 Information on flammability.6.5 For exoskeletons intended for medical use, manufact

25、ur-ers should follow applicable laws, regulations, and guidance.7. Keywords7.1 exoskeleton; labeling; wearable roboticsASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressl

26、y advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, e

27、ither reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may atte

28、nd. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. I

29、ndividual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 182