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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 054 Date of Entry 07/06/2020 
FR Recognition Number 5-130
Standard
ISO  7010 Third edition 2019-07
Graphical symbols - Safety colours and safety signs - Registered safety signs
Scope/Abstract
This document prescribes safety signs for the purposes of accident prevention, fire protection, health hazard information and emergency evacuation.

The shape and colour of each safety sign are according to ISO 3864-1 and the design of the graphical symbols is according to ISO 3864-3.

This document is applicable to all locations where safety issues related to people need to be addressed. However, it is not applicable to the signalling used for guiding rail, road, river, maritime and air traffic and, in general, to those sectors subject to a regulation which may differ with regard to certain points of this document and of the ISO 3864 series.

This document specifies the safety sign originals that can be scaled for reproduction and application purposes.
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 801 Labeling, medical devices, reporting and recordkeeping requirements
21 CFR Part 660 Biologics, labeling, reporting and recordkeeping requirements
21 CFR Part 809 Labeling, medical devices
Relevant FDA Guidance and/or Supportive Publications*
Final Rule: Use of Symbols in Labeling, Issued June 15, 2016

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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