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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 051 Date of Entry 01/14/2019 
FR Recognition Number 10-74
Standard
ISO  10940 Second edition 2009-08-01
Ophthalmic instruments - Fundus cameras
Scope/Abstract
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This International Standard is not applicable to the following instruments:

- those that contact the eye during the examination;
- those using scanning laser sources.

This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Sub-clause 4.4 Optical radiation hazard with fundus cameras
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.

This standard is recognized in part because:
Sub-clause 4.4 is in conflict with another recognized standard, see ANSI Z80.36 listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.36 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments

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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