NelsonLabs.com is best viewed in Chrome, Firefox, Safari, and Internet Explorer 9 and above.
Version: 1.1.5037.23448-7fe1cda529b97ebc52da0f2bbefb0d41deb9638a

The customer portal will be unavailable on 30 JUN 2017 08:00 PM MDT through 01 JUL 2017 08:00 AM MDT.

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

Standard turn around times (TAT) are listed below. 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 TAT (days) Request Quote
RHL105 Protocol Development & Initial Consult 10 Add
RHL110 Disinfection Validation: HLD 35 Add
RHL120 Disinfection Validation: ILD 35 Add
RHL130 Disinfection Validation: LLD 21 Add
RTD110 Thermal Disinfection: Inoculation 35 Add
RTD120 Thermal Disinfection: A0 21 Add
RHL105 - Protocol Development & Initial Consult
TAT: 10 days
RHL110 - Disinfection Validation: HLD
TAT: 35 days
RHL120 - Disinfection Validation: ILD
TAT: 35 days
RHL130 - Disinfection Validation: LLD
TAT: 21 days
RTD110 - Thermal Disinfection: Inoculation
TAT: 35 days
RTD120 - Thermal Disinfection: A0
TAT: 21 days

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).

Chat Now