ANSI Z80.36:2016 pdf free download – Light Hazard Protection for Ophthalmic Instruments
5.3.1 If an instrument does not fulfil all requirements for a Group 1 instrument, it shall be checked for compliance with Group 2 requirements only for those hazards for which it did not fulfil the requirements of Group 1 . The reporting requirements of clause 7 (b) need only be complied with if Group 1 requirements are not fulfilled for 5.4.1 .1 – Weighted corneal and lenticular ultraviolet radiation irradiance (table 2), or 5.4.1 .2 – Unweighted lenticular ultraviolet radiation radiant exposure (table 2), or 5.4.1 .3 – Retinal photochemical aphakic light hazard, Weighted retinal irradiance (table 2). Visible light is necessary for diagnosis of ocular pathology, and thus is commonly used in instruments such as direct and indirect ophthalmoscopes, slit-lamp microscopes, operation microscopes and endoilluminators. It is not reasonable to set limits on visible radiation that is needed for the diagnosis of disease or for visualization during ocular surgery. A surgeon may have to exceed an exposure level that is known to be potentially hazardous during an extended complicated surgery or a clinician may have to exceed an exposure level that is known to be potentially hazardous during an extended ocular examination for diagnosis of ocular pathology. With this in mind, the standard requires that the time to reach a potentially hazardous exposure be given, rather than to set a limit, so that clinicians are informed about potential optical radiation hazards that may be associated with the use of their instruments should they need to use an amount of radiation that has a high likelihood of causing ocular tissue damage.
When using the requirements of 5.5.2.1 the value of N, the number of pulses, is the number of times the scan passes over the circular aperture of 0.03 mm on the retina. A scanning instrument that does not fulfil the requirements of 5.2.1 for photochemical aphakic light hazard shall fulfil the requirements of clause 7 (b)(1 ) for reporting time to reach the recommended maximum exposure using the procedure of 6.5.3 in which the value of E A-R shall be found using the procedure given in 5.2.1 .
5.3.3 Group 2 instruments shall comply with the emission limits given in 5.5. 5.3.4 The test methods used for determination of compliance shall be in accordance with 6.3 and 6.4. However, if components that are being used in the instrument, e.g., lamps, light-emitting diodes, nonremovable filters, lenses, fibres, etc., prevent some, but not all, emissions specified for Group 2, then provided that documentation of test certification of the respective components is available, measurements shall be required only for those parameters in tables 4 and 5 where the components do not prevent the limits from being exceeded.
5.4.1 Continuous wave instruments
The emission limits specified in table 2 relate to maximum corneal and lenticular or retinal irradiance or instrument radiance as applied directly to the continuous wave instrument’s criteria. To evaluate the respective radiation hazard criteria, the equations given for them in table 2 shall be used. See Table 1 for an explanation of the quantities used in the equations and for associated units.