ANSI Z80.36-2016 pdf free download

ANSI Z80.36-2016 pdf free download.Ophthalmics – Light Hazard Protection for Ophthalmic Instruments.
1 Scope 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 1 5004-1 , 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.
3.1.2 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
3.1.11 maximum intensity highest optical radiation emissions the instrument is capable of delivering under any and all conditions 3.1.12 operation microscope stereo-microscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system, including objective lens, variable or fixed power optical system, observation tube and eyepieces 3.1.13 optical radiation hazard risk of damage to the eye by exposure to optical radiant energy – ultraviolet, visible, or infrared 3.1.14 photoretinitis photochemically induced injury to the retina resulting from a very intense retinal radiant exposure Note 1 to entry: The term “photic maculopathy” is also used to describe photoretinitis in the macular area of the retina. 3.1.15 pulsed light source light source that delivers its energy in the form of a single exposure of known duration of 0.25 s or less or a train of pulses where each pulse in that train has a duration of less than 0.25 s. Note 1 to entry: A light source with a continuous train of pulses or modulated radiant energy where the peak radiated power is at least ten times the minimum radiated power is considered to be a pulsed light source. Note 2 to entry: The nominal pulse duration, ∆t, for pulsed instrument evaluation is determined by the time interval equal to the full width at half maximum of the pulse. The energy integration time, t, is the full pulse width for an individual pulse, and for multiple pulses, it is the time that includes each individual pulse and combination of pulses.