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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 056 Date of Entry 06/07/2021 
FR Recognition Number 10-122
Standard
ISO  10939 Third edition 2017-05
Ophthalmic instruments - Slit-lamp microscopes
Scope/Abstract
ISO 10939:2017, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.

ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers.

ISO 10939:2017 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:
Sections referencing ISO 15004-2:2007 for light hazard protection.
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:
Sections referencing ISO 15004-2:2007 for light hazard protection is in conflict with other recognized standards, see sections on light hazard protection of ANSI Z80.37-2017 listed below. FDA has replaced ISO 15004-2:2007 with ANSI Z80.36:2016 as the recognized standard for light hazard protection in ophthalmic instruments listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Device, Analysis, Anterior Segment Class 2 MXK
§886.1850 Microscope, Specular Class 2 NQE
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered, Exempt Class 2 PUE
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry Slit Lamp Guidance, Issued July 1998.

2. ANSI Z80.37-2017 Ophthalmics - Slit-Lamp Microscopes.

3. ANSI Z80.36-2016 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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