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Validation Function of Medical Sealing Machines
The final medical device sterilization packaging standard ISO 11607-2 requires medical sealing machines to have validation functionality.
This means the sealing machine can self-monitor changes in important operating parameters, such as temperature and pressure, in real time.
When parameters are abnormal, it should alert, alarm, and pause operation to ensure safe and effective sterilization and packaging sealing.
Currently, some sealing machines on the market lack validation functionality, and some, while displaying pressure values on the screen, do not actually have a pressure testing module installed.
These do not meet ISO standards, and buyers should pay special attention when purchasing. MDcare Anka medical sealing machines in the 7, 8, and 386 series are all equipped with a pressure testing module according to the ISO 11607-2 standard.
This module monitors parameters such as sealing date, time, pressure, temperature, speed, operator, and machine number in real time, and saves a workflow record for traceability.
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