ANSI Z80.10-2018 pdf free download – Ophthalmics – Ophthalmic Instruments – Tonometers.
The requirements are met if not more than 5% of the paired differences between the referencetonometer reading and the test tonometer reading for each pressure range are greater than thetolerance for that range in table 1.
NOTE-The tolerances given in table 1 represent 1.96 times the standard deviation allowable for thepaired measurement and so account for not only the allowable error of the tonometer under test but alsothe unavoidable error associated with the reference tonometer. Individual variability may be lower.
4.2.2 The manufacturer shall analyze the data, taken in the course of design compliance testing,as specified in clause 5, using the method of Total Least Squares Regression, and make
available, as required in part (a) of clause 7, the slope of the regression, the offset of theregression and the standard deviation of the regression.
4.3 Verification (Instrument compliance)
4.3.1 The manufacturer shall develop a method and test apparatus to confirm that the
requirements of 4.2 are met by each manufactured tonometer. Each tonometer shall be verifiedwith this method and apparatus.This method and test apparatus shall be the same that were usedto measure and verify the test tonometer in 4.2.Details of the method and test apparatus shall bemade available in accordance with the requirements of clause 7.
4.3.2 The permissible error of the test apparatus shall be one half of the permissible tolerances asgiven in table 1.
4.4 Construction and function
4.4.1 The surfaces of the tonometer that are intended to come into contact with the cornea shallbe:
a) composed of nontoxic, stable and nonoxidative material that is inert to ocular tissues, tears,and appropriate pharmacological agents;
b) designed either to facilitate disinfection or for single patient use;
c) smooth when felt with the finger, and be free of surface imperfections that would damage theeye or prevent adequate disinfection, when examined by unmagnified corrected vision underspecular reflection.
4.4.2 The tonometer shall permit the measurement of lOP throughout the range 7 to 50.The scaleor display shall either provide a direct measurement of a value whose relationship to lOP is knownor give a numerical reading corresponding to the lOP value.
Readings of lOPs less than 7 shall be displayed either by their numerical value or by a “lowreading” indication.
Readings of lOPs greater than 50 shall be displayed either by their numerical value or by a “highreading” indication.
5Test methods
All tests described in this standard are type tests.
5.1 The reference lOP shall be determined as described in annex A. The methods described inannex A also apply to new “Goldmann-type” test tonometers. A new tonometer that meets all ofthe specifications and requirements of annex A is qualified as a reference tonometer, and,
therefore, it does not require the clinical validation described in annex B and 4.2.1.
5.2 Design compliance testing shall be performed as described in annex B.
6 Accompanying documents
The tonometer shall be accompanied by documents containing instructions for use together withmaintenance procedures and their frequency of application. In particular, this information shallcontain:
a) name and address of the manufacturer;
b) instructions for effective disinfection of the tonometer with particular reference to thedisinfection of instruments to be returned to the manufacturer for repair and maintenance;c) lists of contraindications, warnings, and precautions for use of the tonometer, taking intoaccount the inclusion/exclusion criteria of the clinical validation study.;
d) a list of accessories suitable for use with the tonometer;
e) if appropriate, a statement that the tonometer in its original packaging conforms to thetransport conditions as specified in lSO 15004:1-2006;
f) if appropriate, any additional documents as specified in 7.9 of lEC 60601-1:2005 Part 1,3rdedition;
g) a reference to this Standard, i.e.ANSI Z80.10, if the manufacturer or supplier claimscompliance with it;
h) directions for recalibration of instrument and schedule.7 Additional information
The manufacturer shall provide the following information upon request.
a) Ilnformation on the operating principles of the certified tonometer, specific protocol for designcompliance testing (annex B), specific results of design compliance testing with statistical evaluation;ANSI Z80.10 pdf download.