ANSI Z80.36-2016

Standard Organization:

ANSI Z80.36-2016
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments

Recognition Date	2016-09-21
Recognition List	045
Recognition Number	10-102
Extent	Complete standard
Standards Orgs	ANSI American National Standards Institute https://www.ansi.org/
STG	Ophthalmic
FDA Tech	Bruce Drum FDA/OMPT/CDRH/ODE/DOED/DSDB/ 301-796-6466 bruce.drum@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

There is no relevant guidance developed at this time.