Medical Device Cleaning and disinfection Validation

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

Our Accreditations

At Test Labs, we offer testing services to ensure the cleaning and disinfection instructions outlined in your 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.

Identify requirements

We will work with you to identify the type of cleaning (Automated or Manual) and level of disinfection (High, intermediate or low) you need validated.

We also work with you to identify worst case testing conditions and scenarios for your cleaning and or disinfecting procedure and medical devices.

Simulated use testing & Soil selection

Based on AAMI ST98/ ISO 15883-5, the medical device is cleaned and disinfected as per the IFU several times to ensure it is representative of a medical device at its end-of-life cycle.

The representative medical devices are soiled using a validated test soil. The test soil represents contaminants that the device would likely be exposed to during clinical use. The test soil is chosen according to HTM 01-01 or ASTM-F3208-20 and validated according to ISO 15883-5:2021/AAMI ST98.

Cleaning & Disinfection Validation

Automated or Manual Cleaning validation is performed on the representative medical devices using our analyte detection methods e.g. Modified OPA method, Residual ATP analysis.

Automated disinfection is performed on the representative medical devices using thermal disinfection and a Washer Disinfector using Externally calibrated temperature measurement instruments.

Manual Disinfection High, intermediate or low is performed on the representative medical devices by calculating the log reduction of the disinfection process described within your disinfection instruction on selected target organism (e.g. Mycobacteria or other vegetative bacteria/fungi).

Reporting

If soil accumulation or other issues are noticed during testing, you will be updated with the findings while testing is ongoing. At the conclusion of the cleaning or disinfection validation, the results and observations will be processed and summarised into a Test Labs report.

Dental instrument IFU validation in under 4 weeks – Case study

Learn how Test Labs team successfully completed dental instrument IFU validation study in under 4 weeks

Read the full blog post

Cleaning validation with ATP : Everything You Need to Know

Post-cleaning, any residual ATP is collected from the sample and measured using the ATP bioluminescence monitor

Read the full blog post

HTM 01-01: Management and decontamination of surgical instruments used in acute care

HTM 01-01 consists of a list of documents that provide guidance and information on the decontamination and reprocessing of reusabl...

Read the full blog post

Explore our medical device testing services

Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

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Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

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Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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Explore our laboratory areas

Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

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Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

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Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials
development.

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Strong foundations are built with robust Quality Management Systems

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