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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 045 Date of Recognition 09/21/2016 
FR Recognition Number 10-102
Standard
ANSI Z80.36-2016
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
Scope/Abstract
ANSI Z80.36 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
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Microscope, Specular Class 2 NQE
§886.1780 Retinoscope, Ac-Powered Class 2 HKL
§886.1780 Retinoscope, Battery-Powered Class 1 HKM
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§878.4700 Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 HRM
§878.4700 Microscope, Operating, Non-Electric, Ophthalmic Class 1 HRB
§878.4700 Microscope, Surgical, General & Plastic Surgery Class 1 FSO
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Bruce Drum
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6466
  bruce.drum@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
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