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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 5-117
Standard
ISO 15223-1 Third Edition 2016-11-01
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
U.S. Identical Adoption
ANSI AAMI ISO 15223-1:2016
Medical devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements
Scope/Abstract
This document identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. 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.
Transition Period
FDA recognition of ISO 15223 Third edition 2016 11-01 [Rec# 5-117] will be superseded by recognition of ISO Fourth edition 2021-07 [Rec# 5-134]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-117] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 5-117] will not be accepted.
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*
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 Contacts
 Scott A. Colburn
  FDA/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  301-796-6287
  scott.colburn@fda.hhs.gov
 Tosia Hazlett
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-6119
  Tosia.Hazlett@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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