Contact person
Louise Wogelred
Forsknings- och utvecklingsingenjör
Contact Louise
Validation of sterilization of medical devices
In the Instruction for Users (IFU), supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to EN ISO 17665:2024.
Purpose
Contribute to healthcare safety by providing clear and validated instructions for sterilization.
Fulfill requirements in MDR.
Method
Sterilization validation is performed by showing a sterility assurance level (SAL) of 10-6 using, for the method most resistant organism, Geobacillus stearothermophilus, at a concentration enough to show a sterility assurance level (SAL) of minimum 10-6. Inoculated devices are packed according to the instructions and processed with moist heat following the partial cycle approach i.e. a shorter time than stated in the instructions is used. Potential surviving spores on the devices are incubated in growth medium and evaluated for turbidity according to ISO 11737-2.
We can also evaluate that the drying time after sterilisation is enough, to ensure safe storage of the product. RISE provides a Systec DX-90, validated according to ISO 17665 with external temperature probes.
We can also validate the instructions for cleaning and disinfection according to ISO 17664-1/2, ISO 15883-5 and ANSI/AAMI ST98: Validation of instructions and processes for cleaning and disinfection of medical devices | RISE
Deliveries
Methods and results are presented in a written report.
