FDA recognition of ANSI Z80.36-2016 – Ophthalmic Instruments

3 November 2017

Slit Lamp

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

IDR Photobiological Safety Spectroradiometer

IDR300-PSL Photobiological Safety Spectroradiometer.

Test and certification companies and lamp and luminaire manufacturers can now evaluate the photobiological safety of lamps and lamp systems easier, faster and with greater accuracy than ever before.

More articles

Product Launch: Introducing the TLS120Xe Tuneable Light Source

We are pleased to announce the official launch of the TLS120Xe high power tuneable light source, delivering superlative stability and continuous tuning over 280-1100nm.

We’re recruiting!

Bentham is growing and we are looking to recruit the following key roles at our Reading offices.

SCHEER: Are LEDs safe?

The European Commission and SCHEER (the Scientific Committee on Health, Environmental and Emerging Risks) have recently published a Preliminary Opinion assessing the potential health risks associated with LED emissions in the general population.

You are currently offline. Some pages or content may fail to load.