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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 062 Date of Entry 05/29/2024 
FR Recognition Number 4-326
Standard
ISO  9687 Second edition 2015-02
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)]
Scope/Abstract
ISO 9687:2015 specifies graphical symbols for dental equipment. It is intended that the symbols are to be used on the appropriate piece of dental equipment and in documents pertaining to dental equipment, for example in instructions for use, marking, labelling, and 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.

Standard is recognized on a regulatory basis:
- Labeling
- Symbol
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 660 Additional Standards For Diagnostic Substances for Laboratory Tests
21 CFR Part 801 Labeling
21 CFR Part 809 In Vitro Diagnostic Products for Human Use
21 CFR Part 872 Dental Devices
Relevant FDA Guidance and/or Supportive Publications*
Final Rule, Use of Symbols in Labeling, issued June 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
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  Lauren.Giles@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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