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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 027 Date of Recognition 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
§886.4150 Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class 2 HQE
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Dexiu Shi
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6470
  dexiu.shi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
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