• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 042 Date of Entry 06/15/2016 
FR Recognition Number 5-102
Standard
IEC 60417:2002 DB
Graphical symbols for use on equipment
Scope/Abstract
IEC 60417 graphical symbols are primarily intended to:
- identify the equipment or a part of the equipment (e.g. a control or display);
- indicate a functional state (e.g. on, off, alarm);
- designate connections (e.g. terminals, filling points for materials);
- provide information on packaging (e.g. identification of contents, instructions for handling);
- provide instruction for the operation of the equipment (e.g. limitations of use).
IEC 60417 does not apply to symbol originals for:
- safety signs;
- use on drawings and diagrams;
- use in technical documentation of products and in technical product documentation;
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 660 Biologics, labeling, reporting and recordkeeping requirements.
21 CFR 801 Labeling, medical devices, reporting and recordkeeping requirements.
21 CFR 809 Labeling, medical devices.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Scott A. Colburn
  FDA/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  301-796-6287
  scott.colburn@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
-
-