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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 057 Date of Entry 12/20/2021 
FR Recognition Number 10-130
Standard
ANSI  Z80.36-2021
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
Scope/Abstract
This standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all current ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging, or alignment purposes.
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
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§878.4700 Microscope, Surgical, General & Plastic Surgery Class 1 FSO
§878.4700 Microscope, Operating, Non-Electric, Ophthalmic Class 1 HRB
§878.4700 Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 HRM
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
§886.1780 Retinoscope, Ac-Powered Class 2 HKL
§886.1780 Retinoscope, Battery-Powered Class 1 HKM
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Microscope, Specular Class 2 NQE
§886.4390 Laser, Ophthalmic Class 2 HQF
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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