PCA accreditation

The Laboratory - before and now ...

About us ...

The Laboratory deals with measurement and research activities in the field of electrical safety, essential performance and electromagnetic compatibility (EMC) of medical electrical equipment and medical electrical systems.

The Laboratory performs calibration of devices in the field of electrical quantities (current, DC and AC voltage, resistance) and in the field of time and frequency. Calibration includes DC and AC voltage and current generators and calibrators, fixed and adjustable resistors, voltage, current and resistance meters, multimeters and oscilloscopes, time and frequency generators, time and frequency meters.

Experience of the Laboratory in the field of medical and non-medical electrical equipment researching and electrical measurements, calibration and monitoring of control and measuring equipment goes back to 30 years. The first measurements were made in 1986.

The Laboratory has dedicated rooms for conducting the above mentioned tests and measurements and is equipped with modern, precise measuring and testing equipment, operated by specialized staff with extensive experience.

The Laboratory has got two accreditation certificates :
  • research Laboratory accreditation certificate nr AB 1604,
  • calibration Laboratory accreditation certificate nr AP 161,
issued by the Polish Accreditation Center (PCA) which operates in accordance with EN ISO / IEC 17011.

A little bit of history

Year 2002 and earlier ...
The Laboratory was set up on September 2, 2002. By this date, the Laboratory was scattered between the departments of the company specializing in the manufacture of electronic medical devices. The activity included supervision of measuring instruments, calibration of electrical measuring instruments and tests for compliance with the applicable standards for electrical safety of medical devices..

Year 2004
In year 2004, the Laboratory obtained Accreditation Certificates, granted by the Polish Accreditation Centre, confirming compliance with the requirements of EN ISO / IEC 17025:
  • Research Laboratory accreditation certificate nr AB 488 (with the day 24.05.2004),
  • Calibration Laboratory accreditation certificate nr AP 161 (with the day 04.06.2004),
in terms of qualitative competence requirements.

Year 2005
Since 2005, EMC testing has developed rapidly. The Laboratory was equipped with a TDK chamber with measuring distance of 3 m and the necessary measuring equipment. This made it possible to offer more measurement and research services concerning EMC. On February 12, 2007 the Laboratory has been awarded with accreditation for EMC Emission and Immunity testing..

Year 2008
Since 2008, the Laboratory has not been accredited, but this did not affect the quality of the management system which was and still is in accordance with the requirements of EN ISO / IEC 17025. The lack of accreditation did not stop the further development of the Laboratory in range of test and calibrations.

Year 2011
In 2011, the Laboratory broadened its research activities. A specialist spirometry calibrator has been developed and implemented to test flow meters of peak respiratory flow and spirometers for evaluation of respiratory function.

Year 2013
The development of the company in the field of stationary training equipment caused in 2013 further expansion of research activities of the Laboratory. A research post, being a place and also a device for stationary training equipment testing of movable treadmill (powered by electric motor or manual).

Year 2014
In response to the development of M2M (Machine-to-Machine) telecommunication and communications, the Laboratory purchased the specialized coupling and decoupling networks (CDN), extending the scope of the EMC testing of immunity to conducted disturbances on USB and Ethernet communication lines. It also enabled the Laboratory to perform conducted emission tests on the Ethernet communication line.

The breakthroughs of 2014 and 2015 started the preparations for the accreditation process in order to re-acquire the Accreditation Certificates issued by the Polish Accreditation Center for research and calibration activities.

Year 2015
The intensity of work in 2015 resulted in the modernization of the cycloergometer research station. A modern and accurate cycloergometer calibrator has been developed, enabling automated normative testing of stationary cycloergometer equipment.

Additionally, in 2015 key decisions were made regarding the expansion and modernization of the Laboratory. Works on the renovation of the Laboratory rooms have been started and new measuring and testing instruments have been purchased including: EMI measurement receiver up to 6 GHz, spectrum analyzer up to 13 GHz, measuring antenna up to 18 GHz, harmonic analyzer, change and voltage fluctuation analyzer combined with flickering analyzer.

Year 2016
In April 2016, the Laboratory obtained Accreditation Certificates, granted by the Polish Accreditation Center again, confirming the fulfillment of the requirements of EN ISO / IEC 17025:
  • Research Laboratory accreditation certificate nr AB 1604 (with the day 11.04.2016 r.),
  • Calibration Laboratory accreditation certificate nr AP 161 (with the day 28.04.2016 r.).

StaffMain page