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.

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.

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

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

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...

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.

Medical devices bioburden testing

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

Disinfection products for medical devices

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

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.

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.

Chemistry Laboratory

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

Strong foundations are built with robust Quality Management Systems