Hello Joerg,
There is no documentation that certifies that the production of this part is made under clean room conditions and the part is no sterilized after production .This device have been designed with bio-medically approved materials with a history in medical situations to provide a sensor that can be used with confidence in applications, such as invasive blood pressure monitoring. It can be sterilized using ethylene oxide and it meets all USP XX Biological Testing Class VI requirements.
Darío
