Contact person
Louise Wogelred
Forskare
Contact Louise
Medical Devices – validation of cleaning and disinfection
In the Instruction for Users, supplied with reusable medical devices, validated instructions for cleaning and disinfection must be included. We can assist you in developing good instructions and validate that your products get clean and disinfected, according to e.g. ISO 17664, ISO 15883 and/or AAMI TIR30.
Purpose
Contribute to healthcare safety by having clear and validated instructions for cleaning and disinfection.
Fulfill requirements in MDR.
Method
The cleaning procedure is validated by soiling the product, with e.g. blood, cleaning according to instruction followed by analysis of remaining soil e.g. with protein analysis.
For disinfection, bacteria or spores are used, sometimes in combination with soil depending on product and procedure.
Deliveries
Methods and results are presented in a written report.
Ordering
Please find contact information below
Facts
Service
Medical Devices – validation of instructions and processes for cleaning and disinfection, following MDR and FDA
Innovation area
Infection control, Chemical and biological analysis, Medical devices
Price
Please contact us for price information
Preparations
The customer prepares the test items unless otherwise agreed
