Peracetic acid is used for the disinfection of medical devices as it acts as a disinfectant. According to the definitions of Regulation (EU) 2017/745 on medical devices, products specifically intended for the cleaning, disinfection or sterilisation of medical devices and active devices are also considered medical devices.
While PERACLEAN® 6 Steri and PERACLEAN® 6 are not notified as a medical device, the quality management system for manufacturing these products is EN ISO 13485 certified. With this, the ability to supply (toll manufacturing) a medical device according to the requirements of the norm is documented. Meeting this norm on its own does not authorize for using a CE-label, but a conformity assessment procedure for the medical device by a notified body is necessary. Evonik is no manufacturer according to Regulation (EU) 2017/745 definitions as it does not market a medical device under its name or trade.
PERACLEAN® 6 Steris and PERACLEAN® 6 are specialty peracetic acid grades. PERACLEAN® 6 Steris are manufactured for the use in medical applications, such as sterilization of surgical instruments and medical devices (e.g. endoscopes, optics, hemodialysis).
Disinfectant for medical devices