ANSI Z80.10 pdf free download
ANSI Z80.10 pdf free download.Ophthalmic Instruments – Tonometers.
3 Definitions For the purpose of this standard, the following definitions apply. 3.1 Goldmann-equivalent measurement: An intraocular pressure measurement taken with an instrument that meets the requirements of 4.2 to 4.4 when compared to the Goldmann reference tonometer. The instrument may also present intraocular pressure data in other formats. 3.2 intraocular pressure (IOP): The pressure within the eye in millimeters of mercury (mmHg). NOTE- 1 mmHg = 1.333 hPa 3.3 measured IOP: The IOP reading provided by the instrument when used in accordance with the manufacturer’ s instructions. 3.4 reference IOP: The IOP that is measured with the reference tonometer (annex A) in accordance with the procedures given in annex B. 3.5 reference tonometer: A tonometer as described in annex A. 3.6 test tonometer: The verified tonometer used in design compliance testing.
4 Requirements dasaut 0001 4.1 General The tonometer shall conform to the requirements specified in ISO 15004:1:2006. The tonometer shall conform to the specific requirements specified in 4.2 to 4.4 for measured values designated as Goldmann-equivalent. This standard does not prevent presentation of additional parameters or interpretations of the data that differ from Goldmann-equivalent measurements. However, if compliance with this standard is claimed, a tonometer shall make Goldmann-equivalent values available to the user and shall designate them as measurements conforming to ANSI Z80.10. 4.2 Type testing (certification) 4.2.1 The manufacturer shall demonstrate, on the basis of design compliance testing as specified in clause 5, that the test tonometer measurements compared to the reference tonometer measurements meet the requirement as given in table 1.
The requirements are met if not more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance for that range in table 1. NOTE – The tolerances given in table 1 represent 1.96 times the standard deviation allowable for the paired measurement and so account for not only the allowable error of the tonometer under test but also the 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 the regression 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 verified with this method and apparatus. This method and test apparatus shall be the same that were used to measure and verify the test tonometer in 4.2. Details of the method and test apparatus shall be made 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 as given in table 1.
5 Test methods AlI tests described in this standard are type tests. 5.1 The reference IOP shall be determined as described in annex A. The methods described in annex A also apply to new “Goldmann-type” test tonometers. A new tonometer that meets all of the 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.ANSI Z80.10 pdf download.
