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).
Disinfection of medical devices
Peracetic acid has to be stored in original containers or tank farms in an ambient condition protected from the direct sun irradiation area. It is important to keep peracetic acid protected from all types of contamination and away from of combustible/ oxidizable materials. Containers should be stored unopened and in an upright position.