Medical Device Disinfection Validation

We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.

Our Accreditations

Applicable Standards

BS EN ISO 17664-1:2021 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
BS EN ISO 15883-1:2009+A1:2014 - Washer-disinfectors. General requirements, terms and definitions and tests
BS EN ISO 15883-2:2009 - Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
AAMI TIR12:2020 - Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

Test Organisms

Low Level Disinfection - Required organisms: Pseudomonas aeruginosa; Staphylococcus aureus; Escherichia coli; Klebsiella pneumoniae - Log6 reduction for vegetative bacteria.
Intermediate Level Disinfection - Required organisms: Pseudomonas aeruginosa; Staphylococcus aureus; Escherichia coli; Klebsiella pneumoniae; Mycobacterium terrae - Log6 reduction for vegetative bacteria and Log3 for Mycobacterium.
High Level Disinfection - Required organism: Mycobacterium terrae - Log6 reduction required.
Other organism are available for selection, based on your specific requirements e.g. Cdiff; Aspergillus brasiliensis; MRSA etc.

Thermometric Disinfection

For thermal disinfection processes using automated washer disinfectors, disinfection is achieved using heat according to the A0 concept value. The A0 value is the equivalent time in seconds at 80 °C, delivered by the disinfection process, with reference to a microorganism. For example an A0 of 600 for a 90°C temperature is 1 minute (equivalent to 80°C at 10 minutes).

Medical Device Disinfection Validation

We offer testing services to ensure the disinfection instructions outlined in your Medical Device Instructions for Use (IFU) have been fully validate. As outlined in the ISO 17664 Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices (part 1 Critical and semi-critical medical devices, and part 2 Non-critical medical devices), all Medical Devices manufactures are responsible to provide instruction of use when reprocessing of the device is intended. These instruction shall be fully validated to ensure safety of the device. Both manual and automated (Washer disinfector) processes shall be validated as per ISO 17664.