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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 062 Date of Entry 05/29/2024 
FR Recognition Number 10-134
Standard
ISO  10943 Fourth edition 2023-01
Ophthalmic instruments - Indirect ophthalmoscopes
Scope/Abstract
This document, 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 document takes precedence over ISO 15004-1 and ISO 15004-, if differences exist.

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

This document 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
Partial recognition. The following part(s) of the standard is (are) not recognized:
Any reference to ISO 15004-2 in the 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.

This standard is recognized in part because:
Reference to ISO 15004-2 for light hazard protection is in conflict with another FDA-recognized standard, see ANSI Z80.36-2021 listed below. FDA has replaced ISO 15004-2 with ANSI Z80.36 as the recognized standard for light hazard protection in ophthalmic instruments.
Transition Period
FDA recognition of ISO 10943 Third edition 2011-08-15 [Rec# 10-70] will be superseded by recognition of ISO 10943 Fourth edition 2023-01 [Rec# 10-134]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-70] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 10-70] will not be accepted.
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, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.36-2021 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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