Hi everyone, This is my first post. My question is this: as a manufacturer of a reusable device that we are seeking CE mark on, do we need to have a lab validate cleaning, disinfection, etc. per ISO 17664 or are there some accepted validated methods that we can use?
If a lab must do it, can anyone recommend one?

Hi everyone, This is my first post. My question is this: as a manufacturer of a reusable device that we are seeking CE mark on, do we need to have a lab validate cleaning, disinfection, etc. per ISO 17664 or are there some accepted validated methods that we can use?
If a lab must do it, can anyone recommend one?
Hi Carrie, and welcome to the cove.

You definitely need two validated methods (a manual cleaning process and an automatic process), using a suitable test soil and indicator. Generally you need to show a three log reduction in contaminants, measured using an indicator organism spike, a protein assay, or something equivalent. "Standard" methods (i.e. "follow disinfectant manufacturer's guidelines ....") are no longer accepted by the end user, and the agencies are beginning to ask for specific validated methods as well, especially if the device has hard-to-reach/clean areas.

If you cannot do the validation in house, then I suggest looking at Ethox and Nelson Laboratories, both of whom have done this type of study for me in the past. Although ISO17664 is the international standard I suggest that you also look at the US AAMI guidelines TIR12, which is a guide to designing and testing reusable devices and TIR:30 which is a compendium of methods that are commonly used to validate different devices, including advice on test soils, recovery efficiencies and recovery methodologies. I know these are US documents and you are seeking CE marking, but they really are the best guide to this process, offering much more specific guidance than ISO17664.

Let me know if you need more information,

Jimmy

Thanks so much, Jimmy! I will look into these labs as well as the standards. I appreciate the help.