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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 5-124
Standard
ISO  7000 Sixth edition 2019-07
Graphical symbols for use on equipment - Registered symbols
Scope/Abstract
The ISO 7000 database provides a collection of graphical symbols which are placed on equipment or parts of equipment of any kind in order to instruct the person(s) using the equipment as to its operation.

Each graphical symbol is identified by a reference number and contains a title, graphical representations in vectorized and non-vectorized formats, and some additional data as applicable, such as the function or the description of the symbol, the intended use, related symbols or publications. Various search and navigation facilities allow for easy retrieval of graphical symbols.
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)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 660 Biologics, labeling, reporting and recordkeeping requirements.
21 CFR Part 801 Labeling, medical devices, reporting and recordkeeping requirements.
21 CFR Part 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
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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