ANSI Z80.36:2016 pdf download.Ophthalmics一Light Hazard Protection for Ophthalmic Instruments.
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.
ANSI Z80.36 does not apply to radiation that is intended for treatment of ocular tissues.
NOTE 1 to entry: Concerning the treatment beams of therapeutic devices, when risk assessments for non-target tissues are conducted, the limits given in this Standard can be applied to the treatment beam.
ANSI Z80.36 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.
NOTE 1 to entry: The emission limits are based on the International Commission on Non-Ionizing Radiation Protection
(ICNIRP) guidelines for human exposure to optical radiation. The limits and guidelines in this standard also account for the
likelihood that eyes may be dilated and that eyes and head may be stabilized during ophthalmic examinations. See
Bibliography [1].
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15004-1, Ophthalmic instruments — Fundamental requirements and text method — Part 1. General requirements applicable to all ophthalmic instruments
3 Terms, definitions and symbols
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1.1
aperture
aperture stop
opening that defines the area over which average optical emission is measured
Note 1 to entry: For spectral irradiance measurements, this opening is usually the entrance of a small sphere placed in front of the radiometer/spectroradiometer entrance slit.
3.1.2
continuous wave radiation source CW radiation source
radiation source that is, or can be, operated with a continuous output for a time that can be greater than 0.25 S (i.e., a non-pulsed radiation source)
3.1.3
dose-limited instrument
ophthalmic device for which the emission exceeds the Group 1 dose-rate (irradiance) limits, but through its design and construction cannot expose an eye to radiation that reaches the cumulative exposure limits given in Table 5 and 6.5 within a 24-hour period.
3.1.4
effective aperture
portion of the aperture that limits the amount of light delivered to the retina
Note 1 to entry: For an obscured or noncircular aperture, it comprises an area equivalent to that of a nonobscured circular aperture.ANSI Z80.36 pdf download.