FDA recognition of ANSI Z80.36-2016 – Ophthalmic Instruments
3 November 2017
Up until now, the FDA recognised ISO 15004-2: 2007 for the evaluation of light hazard associated with ophthalmic instruments including direct and indirect opthalmoscopes, slit lamps, fundus cameras, endoilluminators, and operation microscopes for ocular surgery. From March 31, 2018, declarations of conformity must be made with reference to ANSI Z80.36-2016.
ISO 15004-2: 2007 specifies fundamental requirements for the optical radiation safety for ophthalmic instruments that direct light into or at the eye and for which there are specific light hazard requirements within their respective international standards. Sources are classified into either group 1 or group 2 in order to distinguish non-hazardous instruments from those that are potentially hazardous. Revision of this standard was cancelled due to concerns of safety of proposed changes and is to be revised in the near future.
ANSI Z80.36-2016 was developed when proposed changes to ISO 15004-2 resulted in recommendations for levels of radiant exposure for the retinal photochemical hazard that were deemed unacceptable to the US delegation to the ISO. ANSI Z80.36-2016 is based on the text of ISO 15004-2, but includes the introduction of a time-limited device type, different emission limits for both group 1 and group 2 devices, and modified measurement conditions.
Full text may be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=34488
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