Medical Device Bioburden Testing

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

Medical Device Bioburden Testing

To ensure a level of cleanliness, manufacturers need to determine the presence or absence of bioburden on their sterile or non-sterile medical devices according to requirements of ISO 11737-1:2018+A1:2021. The ISO 11737-1:2018+A1:2021 specifies the requirements to be met for the determination of bioburden of a medical device. The annexes included with this standard provide additional explanations and examples for how to use the test methods deemed suitable to conform with these requirements. The Bioburden test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any product that requires control and/or monitoring of bioburden counts. Even if the risk of product contamination is maintained at low level, the bioburden of the product may fluctuate from batch to batch. Therefore, product manufacturers are recommended to conduct routine tests regularly.

Sterility of medical device that have been exposed to a treatment with the sterilising agent needs to be validated and defined as part of the Essential Requirement of Annex I Directive 93/42EEC. Here at Test Labs, we can validate and ensure that your sterilisation process is achieving the right level of efficacy and prove that is it effective when used with your product. The ISO 11737-2:2020 specifies the general criteria to test sterility of medical devices.

Test Labs provide bioburden testing of medical devices services to support manufacturers at all stages of product development and production.

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.

Reusable medical device reprocessing

Our team will evaluate your procedures for manual and automatic cleaning, disinfection and sterilization.

Disinfection products for medical devices

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

See our research & testing facilities

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 development.

Strong foundations are built with robust Quality Management Systems