ANSI Z80.10:2018 pdf download.Ophthalmics一Ophthalmic Instruments一Tonometers.
ANSI Z80.10, together with ISO 15004-1:2006, Fundamental requirements and test methods — Part 1: General requirements applicable to all instruments — First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (lOP) for the detection, diagnosis, and management of ocular abnormalities.
NOTES
1) The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the true lOP cannot be known, the instrument (annex A) and method (annex B) for determining a reference lOP are established.
2) Clinical tonometers may employ different parameters or correlates in the indirect assessment of measured lOP. 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.
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.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards listed below. Members of IEC and ISO maintain registers of currently valid standards.
ISO 15004-1:2006, Fundamental requirements and test methods — Part 1: General requirements applicable to all instruments — First edition
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance — Third edition
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 (lOP): The pressure within the eye in millimeters of mercury (mmHg).
3.3 measured lOP: The lOP reading provided by the instrument when used in accordance with
the manufacturer’s instructions.
3.4 reference lOP: The lOP 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
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.ANSI Z80.10 pdf download.