Hydrogen peroxide is used for disinfection of medical devices as it acts as a disinfectant. With this purpose and the definition of “accessory” in directive 93/42/EEC, PERSYNT® 350 Steri becomes a medical device (class IIa). Therefore, this product is to be marked with “CE”.
The quality management system for manufacturing the medical device PERSYNT® 350 Steri is EN ISO 13485 certified. With this, the ability to supply (toll manufacturing) the 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 by a notified body is necessary. Evonik is no manufacturer according to directive 93/42/EEC.
PERSYNT® 350 Steri is a specialty hydrogen peroxide grade. PERSYNT® 350 Steri is based on high purity hydrogen peroxide, which was manufactured for the use in medical applications, such as sterilization of surgical instruments and medical devices (e.g. endoscopes, optics, hemodialysis), room and surface sterilization and decontamination (e.g. gas disinfection), teeth bleaching or contact lens disinfection.
Typical Applications
- Sterilization of surgical instruments and medical devices
- Room and surface sterilization and decontamination
- Teeth bleaching
- Contact lens disinfection