Methods of determination of biomeasurement uncertainties

Garant předmětu:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

The aim of the course is to introduce students to metrology and certification for medical devices and to related legislation.

Requirements:

Teaching takes place in the form of self-study with regular consultations. In addition to the examination, a written study is required by the student on the subject.

Syllabus of lectures:

1. Methodology Act. National metrology system.

2. System of legal and technical regulations defining the status of state administration bodies and other entities and bodies producing, repairing, and assembling measuring instruments. Users of the measuring instruments.

3.System as a complex of technical devices and equipment. Fundamental scope of the system: fundamental metrology (system of measuring units and national standards), legal metrology (ensuring uniformity and correctness of measurement in the regulated sphere according to the valid legal regulation), industrial metrology, aimed at operating measuring instruments in industry, providing assumptions for achieving high quality products and services in a wide field of measurement and testing.

4.Global metrology system. International cooperation: Metric convention, EUROMET, MRA, OIML, WELMEC.

5. Medical technology and metrology. EU directives relating to designated measuring instruments. International documents and technical standards relating to the metrology of medical technology.

6. Certification of medical technology.

7. Usage of uncertainties and connections to international regulations. Errors of biomeasurements. Uncertainties of biomeasurements, types of uncertainties.

8. Statistical backgrounds for uncertainty determination. Confidence intervals.

9.?10. Evaluation of the standard uncertainties of the input variable by type A and type B methods. Determination of standard uncertainties in direct measurement, laws of uncertainty propagation.

11.?12. Uncertainties combined and expanded, sources of uncertainties. Methods of determining standard uncertainties in indirect measurements, covariance in determining the resulting uncertainties, examples of correlation sources in relation to sources of uncertainty.

13. Measurement models on biosystems.

14. Uncertainty and calibration and verification of measuring instruments.

Syllabus of tutorials:

Study Objective:

The goal of this subject is to inform students about theory of the metrology and the certification by the health care equipment and its related legislature.

Study materials:

Required:

[1] Evaluation of measurement data: Guide to the expression of uncertainty in measurement. JCGM, 2008.

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

Recommended:

GREGORY, K., B. BIBBO a J. E. PATTISON. A standard approach to measurement uncertainties for scientists and engineers in medicine. Australas Phys Eng Sci Med., 2005, vol. 28, no. 2.

Note:

Further information:

Course may be repeated

No time-table has been prepared for this course

The course is a part of the following study plans: