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Disinfection Validation- High, Intermediate & Low Level

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.

Applicable Standards

  • AAMI TIR 12
  • AAMI TIR 30

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test Request Quote
RHL105 Protocol Development & Initial Consult Add
RHL110 Disinfection Validation: HLD Add
RHL120 Disinfection Validation: ILD Add
RHL130 Disinfection Validation: LLD Add
RTD110 Thermal Disinfection: Inoculation Add
RTD120 Thermal Disinfection: A0 Add
RHL105 - Protocol Development & Initial Consult
RHL110 - Disinfection Validation: HLD
RHL120 - Disinfection Validation: ILD
RHL130 - Disinfection Validation: LLD
RTD110 - Thermal Disinfection: Inoculation
RTD120 - Thermal Disinfection: A0

Study Outline

For 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).

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