Medical Device Disinfection Validation

Yes. Cleaning and disinfection are separate, complementary steps: cleaning must be validated first, and disinfection must then be validated to show the process delivers the intended microbial risk reduction for your device and use conditions.

Manual disinfection: we verify the IFU’s contact time, temperature, chemistry, and method are effective and reproducible under worst‑case, operator‑to‑operator variation.

Automated disinfection (e.g., washer‑disinfectors): we follow the ISO 15883 series to demonstrate performance with defined loads, utilities, and parameters.

Core references are: ISO 17664‑1/‑2 (what manufacturers must provide in IFUs), the FDA 2015 Reprocessing Guidance (how to validate reprocessing, including disinfection), and the ISO 15883 series for automated cleaning/disinfection systems.

We run simulated‑use testing (if applicable) that reflects your device design, typical soils, and worst‑case conditions; we then execute your IFU’s manual or automated disinfection steps and document that the process parameters and outcomes meet recognised requirements (FDA guidance + ISO 15883 for automated systems).

Effective disinfection depends on effective cleaning: residual soils can shield microbes and invalidate disinfection claims. That’s why regulators expect cleaning to be validated and documented before (or alongside) disinfection validation in the technical file.