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.
Contribute to healthcare safety by having clear and validated instructions for cleaning and disinfection.
Fulfill requirements in MDR.
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.
Methods and results are presented in a written report.
Please find contact information below
Medical Devices – validation of instructions and processes for cleaning and disinfection, following MDR and FDA
Chemical and biological analysis, Medical devices
Please contact us for price information
The customer prepares the test items unless otherwise agreed