Disinfection validations are used to validate device manufacturer’s disinfection instructions for reusable medical devices. Disinfection validation testing is specifically needed when a device can’t be sterilized using elevated temperatures (e.g., steam sterilization, dry heat), is not compatible with EO or STERRAD sterilization methods, or does not need to be sterilized according to the Spaulding Classification. Validations may be performed to support high-level disinfection, intermediate-level disinfection, and low-level disinfection processes depending on the intended use of the device. This includes the use of applicable organisms, disinfection methods outlined by the manufacturer’s instructions for use, and log reduction evaluation. Validation testing may be needed when disinfection is an interim process prior to terminal sterilization, such as thermal disinfection in automated washer-disinfectors.
Applicable Standards
- AAMI TIR12
- ANSI/AAMI ST58
- ANSI/AAMI ST79
- ISO 15883 series
- ISO 17664 series
- FDA guidance documents
Device Type Expertise*
- Surgical Instruments
- Orthopedics
- Ear Nose Throat (ENT)
- Dental
- Respiratory
- Flexible/Rigid Endoscopes and accessories; Transesophageal (TEE) probes
- Robotics
- Dialysis
- Homecare
- Capital Equipment
- UV disinfection equipment and accessories
* Our scope of expertise is continuously expanding. A Nelson Labs expert can help develop methods and test plans for a variety of devices outside of the specifics listed above.
