Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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027
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Date of Entry 08/02/2011
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FR Recognition Number
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10-65
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Standard | |
ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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 |
§874.4350 |
Source, Carrier, Fiberoptic Light |
Class 1 |
EQH |
§876.1500 |
Endoilluminator |
Class 2 |
MPA |
§876.1500 |
Endoilluminator, Reprocessed |
Class 2 |
NKZ |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |