BS EN ISO 12836 pdf free download

BS EN ISO 12836:2015 pdf free download.Dentistry一Digitizing devices for CAD/CAM systems for indirect dental restorations Test methods for assessing accuracy.
4 Requirements
4.1 General
The manufacturer of the digitizing device shall provide product-specific information including instructions for use.
The digitization device shall be driven by software recommended by the supplier or manufacturer for digitization and rendering of the scanned physical object surface.
4.2 Accuracy
The manufacturer of the digitizing device shall provide product-specific information on the accuracy (trueness and precision) of the digitizing device (e.g. a description of the tested object) in the instructions for use.
In order to determine the quality of a digitizing device in terms of accuracy. repeatability, and reproducibility, known physical objects shall be analysed for structures that are important for the purpose of generating indirect dental restorations. The manufacturer of the digitizing device shall report on the tests carried out, for example, in the instructions for use.
From the assessment performed with the test specimens specified in Annex A. Annex B. or Annex C. the
manufacturer shall derive comprehensive documentation.
The test procedure used shall be reported.
EXAMPLE Tested in accordance with Iso 12836:2012, Annex A, Inlay-shaped specimen.
5 Test methods
5.1 General
Use at least two of the test methods described in Annex A, Annex B, and Annex C.
5.2 Test conditions
Testing shall be done under the following test conditions:
a) the change of temperature during the test shall remain within ±1 °C;
b) the ambient room temperature shall be (23 ± 2) °C in accordance with Iso 554;
c) the quality of the data set in terms of any missing or corrupted data shall be evaluated by the operator; in cases of missing or corrupted data, the test shall be repeated.
5.3 Accuracy
5.3.1 Repeatability
Repeat the measurement 30 times without removing the test specimen from the digitizing device. Use the test specimen and procedures specified in Annex_A, Annex_B. or Annex_C as recommended in the manufacturer’s instructions for use. Calculate the mean and standard deviation of the 30 measurements. Record this value(s).
5.3.2 Reproducibility
Repeat the measurement 30 times, removing the test specimen from the digitizing device and replacing it Into the digitizing device. Use the test specimen and procedures specified in AnnexA, Annex B. or Annex_C as recommended in the manufacturer’s instructions for use. Calculate the mean and standard deviation of the 30 measurements. Record this value(s).
5.3.3 Trueness
Calculate the difference between the mean of the 30 repeatability measurements and a true value obtained independently according to the respective annex. (See A.6.2. B.6.2. or C.6.2).
6 Test report
Prepare a written test report. The test report shall contain at least the following information:
a) a reference to this International Standard, i.e. ISO 12836:20 15;
b) a reference to the annexes of this International Standard used for testing;
c) identification of the test specimen (i.e. inlay-shaped specimen, crown-shaped specimen, bridgeshaped specimen, sphere specimen);
d) specimen surface preparation;BS EN ISO 12836 pdf download.