Medical devices are critical for patient safety and accurate diagnosis. For a device to maintain its measurement accuracy over time, it must be calibrated at regular intervals. But how is this interval — the calibration period — determined?
Why does the calibration interval matter?
Every measuring device drifts away from its original accuracy due to use, environmental conditions and time. When the tidal volume delivered by a ventilator, the energy produced by a defibrillator, or the weight shown by an electronic scale drifts, it directly affects clinical decisions. The right interval ensures the device is rechecked before drift exceeds the acceptable limit.
What determines the interval?
The calibration interval is not governed by a single rule; several factors are weighed together:
- Legal regulation: The Turkish Regulation on Testing, Inspection and Calibration of Medical Devices (25 June 2015) defines the calibration obligation and general framework for healthcare institutions.
- Manufacturer recommendations: The interval suggested in the device manufacturer's user manual is the starting point.
- Risk class and usage frequency: A device running continuously in intensive care is not held to the same interval as one used a few times a month.
- Historical calibration data: The drift trend seen in previous certificates is the most reliable indicator for shortening or extending the interval.
Common practice: annual calibration
For the vast majority of medical devices, the common practice is calibration every 12 months. However, critical devices (e.g. anesthesia and ventilator systems, defibrillators) may be calibrated as often as every 6 months, while lower-risk equipment may extend to 24 months. The deciding factor is keeping the device's measurement reliability guaranteed between two calibrations.
Situations requiring off-schedule calibration
Calibration may be needed before the calendar interval expires:
- The device was dropped, took an impact, or was relocated
- A repair, part replacement or software update was performed
- Measurement results are in doubt
- Environmental conditions (temperature, humidity) changed significantly
Managing the right interval
At Dijital Teknoloji Servisi, we perform the testing, inspection and calibration of all your medical devices on site, independent of brand and model. With our TÜRKAK accreditation (AB-0769) and TS EN ISO/IEC 17025 scope, we deliver certified results and help you build a sustainable interval plan for your device inventory.