Contact person
Louise Wogelred
Forskare
Contact LouiseIn the Instructions for User (IFU), supplied with reusable medical devices, validated instructions for cleaning and disinfection must be included. We can assist you in developing the instructions and validate that your products get clean and disinfected, according to e.g. ISO 17664, ISO 15883 and/or ANSI/AAMI ST98 and ANSI/AAMI TIR12.
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 or haemoglobin analysis.
For disinfection, bacteria are used, sometimes in combination with soil depending on product and procedure. We can also validate thermal disinifection using temperature probes, to ensure that the product fulfilles a certain A0-value.
Methods and results are presented in a written report.