ANSI Z80.36-2016 pdf free download – Ophthalmics – Light Hazard Protection for Ophthalmic Instruments.
ANSI Z80.36 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and isapplicable to all current ophthalmic instruments that direct optical radiation into or at the eye. lt is alsoapplicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye,aswell as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye fordiagnostic, illumination, measurement,imaging, or alignment purposes.
ANSIZ80.36 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 tissuesare 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 distinguishinstruments 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-lonizing Radiation Protection(ICNIRP) guidelines for human exposure to optical radiation. The limits and guidelines in this standard also account for thelikelihood that eyes may be dilated and that eyes and head may be stabilized during ophthalmic examinations.SeeBibliography [1].
2Normative references
The following documents，in whole or in part,are normatively referenced in this document and areindispensable 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: Generalrequirements 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 infront of the radiometerl 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.
3.1.5
endoilluminator
device consisting of a light source and an associated fibre optic light guide that is intended for insertion into the eye to illuminate any portion of the interior of the eye
3.1.6
field-of-view
conical solid angle as “seen” by the detector, such as the eye or the radiometer/spectroradiometer, out of which the detector receives radiation
Note 1 to entry: The field-of-view denotes the angle over which radiance is averaged (sampled) and should not be confused with the angular subtense of the source a which denotes source size.
3.1.7
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists and that fulfils the requirements of 5.2
3.1.8
Group 2 instrument
ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of 5.2 but does fulfil the requirements of 5.3。ANSI Z80.36 pdf download.