ISO 22665-2012 pdf free download

ISO 22665-2012 pdf free download.Ophthalmic optics and instruments Instruments to measure axial distances in the eye
Optique et instruments ophtalmiques — Appareil pour le mesurage de Ia Iongueur axiale de l’oeil.
5.3 Measurements with ultrasound biometry instruments
Measurements using ultrasound instruments shall be performed in contact mode as well as in immersion mode. For immersion measurements, the test cylinders are to be immersed in distilled water in a suitable cuvette and oriented according to the desired dimension to be measured.
To prevent excessive uptake of water, the test bodies shall only be immersed in water for the duration of the measurements.
The ultrasound instrument has to be set up to operate In the aphakic mode.
The temperature of the test bodies shall be determined in order to allow a temperature correction for the propagation speed of sound through the test body material.
The measured values are transformed into times of flight and then reconverted into geometrical distances by means of the temperature-corrected velocity of sound for the test body material. For details, see Annex A.
5.4 Measurements with optical biometry instruments
The optical biometry instrument has to be set up to operate in a mode which allows the optical path length of the test body to be obtained.
The temperature of the test bodies shall be determined in order to allow a temperature correction for the group refractive index of the test body material.
The measured values are then reconverted into geometrical distances by means of the temperature-corrected group refractive index for the test body material, For details, see Annex A.
6 Accompanying documents
The instrument shall be accompanied by documents containing instructions for use and any necessary precautions. In particular, these documents shall contain the following information:
a) name and address of the manufacturer or his authorized representative as required by legislation;
b) instructions as to effective disinfection of the components of the axial length measuring device which are in contact with the patient with particular reference to instruments returned to the manufacturer for repair and maintenance;
c) any additional documents as specified in IEC 60601-1;
d) a reference to this International Standard. I.e. Iso 22665:2012, lithe manufacturer or supplier claims compliance with it;
e) instructions for use, if not already specified by IEC 60601-1.ISO 22665-2012 pdf free download.