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 medical device certification 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.
Examples:
TYMC “Total yeast mould count”
TAMC “Total aerobic count”
Specific pathogen testing, e.g. testing your product for presence of E. coli, S. aureus, P. Aeruginosa, C. Albicans etc. Using ISO 11737 in conjunction with ISO 11137 to help validated the preferred sterilisation method of your product.
Frequently Asked Questions
Why is bioburden testing required for non-sterile devices?
For non-sterile devices, it supports the manufacturing process control and hence risk management. The purpose of bioburden testing changes for sterile products, which uses the results as a critical input for sterilisation validation as well as routine monitoring.
How often should bioburden testing be performed?
Bioburden testing should be routinley performed as part of ongoing manufactruing control, particularly for devices which are made sterile. In terms of frequency, that can differ from device to device, and is determined by devcice type, manufacturing consistency, and regulary guidelines.
How does bioburden testing support sterilisation validation?
As bioburden data is used to determine the baseline level of viable organisms, it can be used to determine that the chosen sterilisation process consistency achieves the required level of microbial reduction- providing evidence that the sterilisation process is effective for the product.
What causes a high bioburden count?
A high bioburden count is primarily caused by contamination introduced during the various phases of manufacturing a medical device. Sources of contamination can come from personnel handling, environmental exposure, or even the water used in production.
Is suitability testing recommended?
Yes, this preliminary test validates the test method and screens for any substances on the device or introduced during recovery that may affect bioburden measurement. If interference is detected, a neutralisation step is implemented to ensure accurate results.