User manual



that the safety and health of the users or third persons are threatened or the usability period

determined by the manufacturer or the importer has expired.

According to Chapter 24, the healthcare providers are obliged to adopt such measures

in the medical devices with measurement functions, as to guarantee sufficient accuracy and

reliability of the measurement. The provider must therefore guarantee to meet the

requirements ensuing from the Law on metrology No. 505/1990 Coll., as amended. In case of

assigned gauges, this means their verification within the statutory limit, and in case of non-

assigned gauges, it is necessary to meet the calibration dates recommended by the

manufacturer.

Periodical safety-technical checks of medical devices are specified in Chapter 27.

Ministry of health may determine the MD types or classes to be regularly checked in a public

notice. This is where the term “periodical safety-technical check” appears, abbreviated to

PSTC. This chapter directly prescribes to maintain the safety of the MD, in our case

specifically the electrical safety of the medical device, the functionality, i.e. the requirement

for the medical device to achieve the technical parameters stated in the manufacturer’s

technical specification. These two requirements cannot be separated from each other.

Last but not least, specification regarding the maintenance and service of the medical

devices is given in Chapter 28. Medical devices must be, in accordance with the

manufacturer’s instructions, professionally, repetitively and demonstrably maintained by

treatment and regular checks in such a state as to guarantee their functionality and safety

throughout the usability period. PSTC and service can only be carried out by a person with

professional training, experience, knowledge of legal regulations and technical standards and

passed training.

Other standards relating to the MD safety:

ČSN EN 60601-1, Part 1 General requirements for essential safety and necessary

functioning

This is the basic standard in the full set of the ČSN EN 60601 technical standards

defining the general technical requirements for the realization and the electrical safety of the

medical devices. Among other things, the standard specifies the requirements for the so called

applied part. The applied part can be found in a majority of medical devices; it is used for

diagnosis or for the treatment operation. The standard divides the applied parts into groups: B,

BF and CF. The most strict requirements concern the CF applied parts, which are used for

invasive operations on the patients.