ANSI Z80.37-2017 pdf download.Slit-Lamp Microscopes
1 Scope
This American National Standard, together with ISO 15004-1 and ANSI Z80.36, specifies requirements and test methods for slit-lamp microscopes to provide slit ilumination and observation under magnification of the eye and its adnexa.
This American National Standard is not applicable to microscope accessories, e.g. photographic equipment and lasers.
This American National Standard takes precedence over ISO 15004-1 and ANSI Z80.36, if differences exist.
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.
ANSI Z80.36, Light hazard protection for ophthalmic instruments
ISO 15004-1, Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments
IEC 60601-1:2005, + Amd.1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 slit-lamp microscope
instrument consisting of a microscope and a swivelling ilumination system providing a slit image
3.2 magnification
ratio of the viewing angle of an object, when observed through a magnifying system with the image at infinity, to that of the object, when observed by the naked eye at a reference viewing distance of 250 mm
4 Requirements
4.1 General
The slit-lamp microscope shall conform to the requirements specified in ISO 15004-1. The slit-lamp microscope shall conform to the requirements specified in 4.2, 4.3 and 4.4. Compliance with these requirements is verified by type testing.
4.2 Optical requirements
The slit-lamp microscope shall conform to the requirements given in Table 1. These requirements shall be verified by use of measuring devices whose measuring errors are smaller than 10 % of the smallest value to be determined. Test results shall be evaluated in accordance with general rules of statistics.
4.3 Construction and function
4.3.1 General
The following requirements shall apply:
a) the parallel slit edges shall be smooth and free from any imperfections when observed using the highest magnification;
b) the slit image shall be evenly iluminated;
no contrast decrease in the slit image caused by reflections or scattered light shall be observed;
d) the brightness and color transmission of the left and right optical systems shall be identical;
e) at the highest magnification, the resolving power in the center of the field shall be at least 1 800 N. Compliance with these requirements is checked by observation.
4.3.2 High eye point eyepiece
If the manufacturer states that the eyepiece is a high eye point eyepiece, the distance between the exit pupil of the observation system and the nearest part of the eyepiece shall be not less than 17 mm.
4.4 Optical radiation hazard with slit-lamp microscopes
This subclause replaces IEC 60601-1:2005 + Amd.1:2012, 10.4, 10.5, 10.6, and 10.7. Slit-lamp microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36. It shall first be determined if the slitlamp microscope is classified as a Group 1 or Group 2 instrument in accordance with ANSI Z80.36, Clause 4. The applicable clauses of ANSI Z80.36 for slit-lamp microscopes are listed below.ANSI Z80.37-2017 pdf download
