Disinfection Validations are used to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. Validations may be performed to support High-Level Disinfection, Intermediate-Level Disinfection, or Low-Level Disinfection processes dependent on the device’s intended use and reuse. These tests are typically needed when a device can’t be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) or is not compatible for EO or STERRAD sterilization methods. Nelson Labs performs validation in compliance with AAMI TIR12, ANSI/AAMI ST58, and FDA guidance documents.
- AAMI TIR12
- AAMI TIR30