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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 052 Date of Entry 07/15/2019 
FR Recognition Number 10-117
Standard
ANSI  Z80.37-2017 (R2021)
American National Standard for Ophthalmics - Slit-Lamp Microscopes
Scope/Abstract
This American National Standard, together with ISO 15004-1 and ANSI Z80.36, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.

This American National Standard is not applicable to microscope accessories, e.g. photographic equipment and lasers.

This American National Standard takes precedence over ISO 15004-1 and ANSI Z80.36, if differences exist.
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
§886.1850 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*
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 Contacts
 Bruce Drum
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6466
  Bruce.Drum@fda.hhs.gov
 Shulei Zhao
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA
  240-402-5358
  Shulei.Zhao@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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