8
Design: In the first stage, the device is designed pursuant to IEC
60601 (if applicable).
Product Testing: During the production stage, the hardware and software
of the device are assembled and verified pursuant to IEC 60601.
Approval for Use: the device has passed the tests and is ready for use.
Operator training: an extremely important step that guarantees the
good use of the device and provides the operator with the best usage
practices and their functionalities.
Preventive Maintenance: the device is subjected to periodic checks
to prevent potential problems. In this step, IEC 62353 is applied.
Calibration: comparison with a known standard to validate the
measurements and parameterization of the device in question. Step
carried out with standard calibration device, calibrated, and with
Inmetro traceability.
Repair: the device undergoes intervention to correct a problem, with the
replacement of parts and components. In this step, IEC 62353 is applied.
Discontinuity: the device reaches the end of its useful life and is
replaced by new technology.
In summary, the application of IEC 60601 is present in the stages
related to the device’s production. IEC 62353 is adopted in the stages
of maintenance and repair of devices in operation.
The purpose of IEC 62353 is to provide a standard that ensures safe
practices, reducing the complexity of IEC 60601 and the stress of the
device under test.
