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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 028 Date of Entry 03/16/2012 
FR Recognition Number 10-70
Standard
ISO  10943 Third edition 2011-08-15
Ophthalmic instruments - Indirect ophthalmoscopes
Scope/Abstract
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.

This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.

This International Standard is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
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
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry Ophthalmoscope Guidance - (Direct and Indirect), Issued July 8, 1998

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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