F7ADIMUNB - Methods of Determination of Bio Measurement Uncertainties

The aim of the course is to introduce students to the use of metrology and certification in medical technology and to related legislation.

As a standard, the teaching in the course is organized in the form of regular meetings. The course ends with an oral exam, which is preceded by written preparation. If the number of students is less than five, the teaching can be organized in the form of guided self-study with regular consultations. Furthermore, a written study on a given topic in the field is required of a student. The condition for admission to the exam is the completion of two laboratory exercises (evidenced by a protocol signed by the student, the head of the exercises and the guarantor of the course). The protocols will be archived in the Department of Doctoral Studies.

1. Metrology Act. National metrological system. The system of legal and technical regulations defining the position of state administration bodies and other entities and between entities manufacturing, repairing and assembling meters and users of meters.

2. The system as a complex of technical means and devices. Basic areas of the system: fundamental metrology (system of measuring units and state standards), legal metrology (ensuring uniformity and accuracy of measurement in the regulated sphere according to applicable legislation), industrial metrology, focused on operating meters in industry, providing the prerequisites for achieving high product quality and services in the broad field of measurement and testing.

3. Global metrological system. International cooperation: Metric convention, EUROMET, MRA, OIML, WELMEC.

4.Medical technology and metrology.

5. EU directives relating to specified measuring instruments. International documents and technical standards related to metrology of medical technology. Medical technology certification.

6. Use of uncertainties and connection with international regulations. Biomeasurement errors. Biomeasurement uncertainties, types of uncertainties.

7.Statistical basis for determining uncertainties. Confidence intervals.

8.Evaluation of standard uncertainties of input variable by the type A method and the type B method. Determination of standard uncertainties in direct measurement, laws of uncertainty propagation.

9. Uncertainties combined and extended, sources of uncertainties. Procedures for determining standard uncertainties of indirect measurements.

10.Covariance in determining the resulting uncertainties, examples of sources of correlations in relation to sources of uncertainties.

1. Measurement models of biosystems (ECG, EEG, EMG)

2. Uncertainties in calibration and verification of meters (pressure measurement—direct and indirect methods).

The aim of the course is to introduce students to the use of metrology and certification in medical technology and to related legislation.

[1] Guide to the Expression of Uncertainty of Measurements, ISO, Ženeva, 1993.

[2] Bucher, Jay L. The metrology handbook. 2nd ed. Milwauke, Wis.: ASQ Quality Press, 2012. ISBN 978-0873898386.

Recommended:

[1] PALENČÁR, R. - VDOLEČEK, F. - HALAJ, M.: Nejistoty v měření I až V, soubor článků v časopise AUTOMA, č. 7-8/2001, č. 10/2001, č. 12/2001, č. 4/2002 a č. 5/2002.

[2] IEC 60359:2001; „Electrical and electronic measurement equipment - Expression of performance“.

[3] ČSN EN 60359 „Elektrická a elektronická měřicí zařízení - vyjadřování vlastností“; ČSNI 2003.