Steam-sterilisable instrument oils according to MDR class 1
An instrument oil may come into contact with patients. The oil is applied after manufacture and during reprocessing. It is an accessory to the medical device and is therefore classified as a Class I medical accessory (MDR).
Instrument oils for the care of medical instruments.
These are classified as Class I medical accessories (MDR):
Manufacturer's declaration of conformity
Notification to BfArM / EUDAMED
Steam sterilisable according to DIN EN ISO 17665 / ISO 13686:
Special additives allow hot steam to penetrate the oil film and sterilise even underneath the oil film.
Medical Fluid 20
No hazardous substance (REACH)
No dangerous goods (ADR, etc.)
Registered as a Class I medical device (MDR)
CE certified
Reported to BfArM and EUDAMED
Monitored and tested by the Regional Council of Tübingen
