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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 027 Date of Entry 08/02/2011 
FR Recognition Number 10-65
Standard
ISO  15752 Second edition 2010-01-15
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
Scope/Abstract
This International Standard specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery.
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
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§886.4150 Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class 2 HQE
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
 Shulei Zhao
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  240-402-5358
  Shulei.Zhao@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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