ANSI Z80.10

Abstract

This standard, together with ISO 15004-1:2009, <em>Fundamental requirements and test methods &#8211; Part 1: General requirements applicable to all instruments &#8211; First edition,</em> specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities. <br>NOTES <br>1) The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the true IOP cannot be known, the instrument (annex A) and method (annex B) for determining a reference IOP are established. <br>2) Clinical tonometers may employ different parameters or correlates in the indirect assessment of measured IOP. The manufacturer states the exact design parameters of the specific tonometer, and then, on the basis of design compliance testing as specified in 4.2, demonstrates that the specific design performs acceptably compared to the reference method. This process is referred to as certification. <br>The manufacturer also demonstrates, by methods specified in 4.3, that individual manufactured instruments perform the same as (within defined limits) the test tonometer. This process is referred to as verification.