Methods of biomeasurement uncertainties determination

Course guarantor:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

System of metrology and relevant legislation. Systems of units, quantities and

standarts. International systems. Medical devices and metrology. EU directives

relevant to the medical devices. International documents and technical norms

relevant to the medical device metrology. Medical device certification.

Measurement errors and uncertainties. Biosystem measurement models.

Uncertainties during calibration.

Requirements:

Syllabus of lectures:

1.The law of metrology. The national metrology system.

2.The system of law and technical rules determinative authority position of

state administration and others subjects.

3.The system as komplex of facilities and equipments. The fundamental

metrology, legal metrology, industrial metrology.

4.The global metrology system. International cooperation: metric convention,

EUROMET, MRA, OIML, WELMEC.

5.The health care equipment and metrology. The directives EU relating to

explicit test gear. International documents and technical standards relative to

metrology of health care equipment. Certification of health care equipment.

6.Uncertainties and connections to international rules. Biomeasuring errors.

Uncertainties of biomeasuring, types of uncertainties.

7.Standards uncertainties by direct measurement. The rules of uncertainties

propagation. Measurement models by biosystems. Calibration uncertainties and

meter verification.

Syllabus of tutorials:

Study Objective:

System of metrology and relevant legislation. Systems of units, quantities and

standarts. International systems. Medical devices and metrology. EU directives

relevant to the medical devices. International documents and technical norms

relevant to the medical device metrology. Medical device certification.

Measurement errors and uncertainties. Biosystem measurement models.

Uncertainties during calibration.

Study materials:

[1] Vejrosta, V.: Konstrukce zdravotnických elektrických přístrojů - aplikace

poľadavků mezinárodních a evropských norem. Praha, Česká společnost pro

zdravotnickou techniku 2001.

[2] Guide to the Expression of Uncertainty of Measurements, ISO, Reneva, 1993

[3] IEC 60359:2001; "Electrical and electronic measurement equipment -

Expression of performance"

[4] ČSN EN 60359 "Elektrická a elektronická měřicí zařízení - vyjadřování

vlastností"; ČSNI 2003

[5] PALENČÁR, R. - VDOLEČEK, F. - HALAJ, M.: Nejistoty v měření I aľ V, soubor

článků v časopise AUTOMA, č. 7-8/2001, č. 10/2001, č. 12/2001, č. 4/2002 a č.

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans: