Quality assurance and calibration of medical equipment
MDR IEC 60601 and your responsibility in daily equipment testing
Behind Every Measurement You Make Stands a Piece of Medical Equipment that Must Meet Strict Safety and Accuracy Requirements. As a Hospital Technical Assistant You are not Personally Responsible for Calibrating the Equipment, but You are Often the One Who Notices if Something is Wrong — and You Must Know What Rules Apply and When Equipment Cannot be Used.
§MDR — the regulations for medical devices
All medical devices used in the EU, including ECG, EEG, and audiometry devices, are covered by the EU's medical device regulation, MDR (EU) 2017/745. The regulation sets requirements for the manufacturer on safety, performance, and documentation before the device can be CE-marked and sold. The rules are supplemented in Denmark by the Medicines Agency, which supervises the device when in use and receives reports of unintended incidents with medical devices.
§IEC 60601 — the technical safety standard
The international standards series IEC 60601 sets out the technical requirements for electrical safety and electromagnetic compatibility (EMC) for medical electrical equipment. The standard ensures that an ECG or EEG device does not supply dangerous current to the patient, and that it is not disturbed by other electronic equipment nearby — or itself disturbs it.
§Who calibrates, and how often?
Calibration and periodic service of measuring equipment is typically handled by the hospital's biomedical department or an external service provider according to a fixed schedule often annually or according to the manufacturer's instructions. The equipment is normally marked with a date for last and next inspection. It is your responsibility in daily work to check this marking before you use the equipment for a patient examination.
| Control point | What you check |
|---|---|
| Calibration label | Is the date of latest and next calibration visible and not exceeded? |
| Cables and electrodes | Are there visible damage, cracks or wear? |
| Self-test at startup | Does the apparatus pass its internal self-test without error message? |
| Physical condition | Are the house, screen and plug intact and clean? |
§Why it matters for you
An imprecisely calibrated device can give a curve or measurement that looks normal but isn't—or vice versa. Your attention to the equipment's condition is therefore just as important a part of examination quality as your actual technical execution.
“The best apparatus is useless if nobody checks that it still measures correctly.”