EN 60601 safety tests

Safety tests in line with the EN 60601 standard require the owners and/or operators of medical equipment to have all the medical equipment that is connected to a 230 V power supply tested once a year by authorised personnel using specific certified equipment and/or instruments.

Medicoengineering carries out safety tests in line with such requirements by using FLUKE-Biomedical equipment, which is fully compliant with the IEC 60601 standards.

The calibration of medical equipment is regulated by collateral standard IEC 60-601-XXX. The XXX codes vary according to the type of medical device. (e.g.: operating lights, ECG devices, CAT devices, surgical blades, etc).

Each piece of equipment has to be tested in line with the collateral standard. So—for example—an ECG machine must undergo a full ECG test; a vital-signs monitor must pass a full ECG test and a series of other tests, such as: SpO2, NiBP, IBP etc.

The number and type of tests to be carried out are laid out in the standards and the manufacturer's instructions, which are usually based on the same standards, if the device is CE certified.

All these tests are also carried out by Medicoengineering using FLUKE-Biomedical equipment, which is fully compliant with the IEC 60601-XXX standards.

According to the EN 60601 standard, any piece of equipment that has not passed a safety test or has not been tested or has not been calibrated shall be considered:

  • Dangerous to operators and patients;
  • The owner/customer shall bear full responsibility for using untested equipment;
  • The owner/customer is thus in clear violation of maintenance requirements.

In order to avoid malfunctioning of untested equipment or accidents using such equipment we advise all the safety tests and calibrations to be carried out in line with the Role II Medical-Equipment Agreement.

Our company will do its best to hire the required number of authorised testers—if needed—to complete all the safety tests and calibration in your practice within one month.

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Medicoengineering d.o.o.

Prevale 1
SI-1236 Trzin
Slovenia

telephone: +386 (0)1 530 26 00
fax: +386 (0)1 530 26 02
e-mail: info@medico-eng.com