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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.

Cause

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

Chemical and biological analysis, Medical devices

Price

Please contact us for price information

Preparations

The customer prepares the test items unless otherwise agreed

Josefin Caous

Contact person

Josefin Caous

Forskare

+46 10 516 59 96
josefin.caous@ri.se

Read more about Josefin

Contact person

Karin Agrenius

Ingenjör

+46 10 516 59 42
karin.agrenius@ri.se

Read more about Karin