Metrology & Certification of Medical Equipment

Lecturer:

Peter Kneppo (gar.)

Tutor:

Peter Kneppo (gar.)

Supervisor:

Department of Biomedical Informatics

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:

Attendance at seminars:

Each seminar 1 item

Maximum13 items

Presentation of required method application:

0- 7 items

Maximum 7 items

Through test:

0-30 items

Ordinarily 25 items

Final test:

0- 50 items

Ordinarily 40 items

Seminar work:

0-20 items

Ordinarily 15 items

Fully - maximum:

100 items

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:

1.Structure of juridical and technical rules in the sphere

of healthcare equipment metrology. Metrological system as

complex of facilities and equipments.

2.Force basic area of metrological system in healthcare

establishments: fundamental metrology, legal metrology,

healthcare metrology, metrology focused on meter's

maintenance in healthcare establishments, metrology

ensuring background for high quality of services in

diagnose and therapy.

3.Global metrological system, international cooperation,

international documents and technical rules of healthcare

equipment metrology.

4.Uncertainties of a bio measurement, types of

uncertainties, input value standard uncertainties

interpretation by A method and B method, combined and

extended uncertainties, sources of uncertainties.

5.Standard uncertainties determination during in a direct

measurement. Standard uncertainties calculation, examples

of correlation sources in sequence to correlation source.

Measurement models on biosystems. Uncertainties in meters

calibration and verification.

6.Hospital metrological regulations and its incorporation

to the system of a quality management. Discretions and

duties of a hospital metrology staff.

7.Presentation of student's semestral works.

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:

[1] Guide to the Expression of Uncertainty of Measurements

ISO, Ženeva, 1993

[2] IEC 60359:2001; "Electrical and electronic measurement

equipment - Expression of performance"

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans: