Contact person
Louise Wogelred
Forskare
Contact Louise
Medical Devices – validation of cleaning and disinfection
In 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.
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 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.
Deliveries
Methods and results are presented in a written report.
Order
Service
Medical Devices – validation of instructions and processes for cleaning and disinfection, following MDR and FDA
Price
Please contact us for price information
Preparations
The customer prepares the test items unless otherwise agreed
Supports the UN sustainability goals
3. Good health and well-being
