Sterilization trays developed and manufactured by AIP Medical must be handled, packaged and used carefully only by health professionals, hospital staff or authorized person.
Sterilization trays are Class 1 medical devices in accordance with Directive 93/42/EEC.
Sterilization trays and accessories may contain:
- Inox stainless steel type 304L
- Biocompatible plastic : Radel PPSU / PP Propylux medical grade
- Biocompatible silicone, medical grade validated for : FDA / 21 CFR / CE / USP Class 6 / ISO 10993
These different materials are certified for medical use, approved for FDA / CE requirements.
Sterilization trays and accessories are designed to enable:
- Packaging, storage and transportation of surgical instruments and accessories
- Cleaning and decontamination of surgical instruments and accessories after the pretreatment
- Sterilization of surgical instruments or accessories after cleaning and drying
Detergents and compatible rinsing products can be used according to the recommendations of the sterilization / washing-disinfection machine manufacturer.
AIP Medical sterilization trays does not provide a sterile barrier and must be prepared before the sterilization. Using a wrap as a sterile barrier should be performed according to the instructions specified in ISO 11607.
The main sterilization method is steam sterilization at 134°C during 18 min, in accordance with ISO 17665. The sterilization trays also support other sterilization methods such as sterilization by flash steam, gamma radiation, ethylene sterilization and hydrogen peroxide sterilization.