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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 057 Date of Entry 12/20/2021 
FR Recognition Number 5-134
Standard
ISO  15223-1 Fourth edition 2021-07
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Scope/Abstract
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.

These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.
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*
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
 Staci Stoller
  CDRH/OST/ORR/DSCA
  301-837-7173
  staci.stoller@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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