Disinfection Validation- High, Intermediate & Low Level
Disinfection Validations are used to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. These tests are typically needed when a device can’t be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) or isn’t compatible for EtO or Sterrad sterilization methods. Nelson Laboratories performs validations in compliance with AAMI TIR12, ANSI/AAMI ST81, and FDA guidance documents.
- AAMI TIR 12
- AAMI TIR 30
Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.
|Code||Test||TAT (days)||Request Quote|
|RHL110||Device Disinfection Validation||Add|
RHL110 - Device Disinfection Validation
Standard TAT not available for this product
Study OutlineFor Disinfection Validations, devices are inoculated with an appropriate concentration of organism(s) and allowed to dry. The disinfection procedure is performed on each device and then the devices are rinsed in sterile water. Each device is then extracted and bioburden is performed on the extracts to determine the number of organism(s) on the positive device compared to the disinfected devices.
High level disinfection: This test requires a 6-log reduction of Mycobacterium spp.
Intermediate level disinfection: This test requires a 6-log reduction of 4 common vegetative organisms (i.e., Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli) and a 3-log reduction of Mycobacterium spp.
Low level disinfection: This test requires a 6-log reduction of 4 common vegetative organisms (i.e., Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli and Staphylococcus aureus).