Medical device bioburden and biocompatibility testing

Bioburden testing determines the load of viable microorganisms present on or in a product, raw material, or component prior to final sterilisation or use, and validates that sterilisation processes will be effective. For IVDs, bioburden testing applies to reagents, calibrators, microfluidic cartridges, and sample collection components.

Abingdon Analytical offers bioburden validation and verification services, including enumeration referenced to ISO 11737-1 which incorporates method suitability and recovery efficiency testing, to support sterilisation validation and ongoing batch monitoring.

Read more: sterilisation and bioburden in your technical file

In vitro diagnostics, and medical devices in general, must perform their therapeutic or diagnostic function without causing adverse effects, such as cytotoxicity, irritation, sensitisation, toxicity, or thrombogenicity.

We offer biocompatibility testing for in vitro diagnostics (IVDs), including extract preparation referenced to ISO 10993-12 and cytotoxicity testing referenced to ISO 10993-5. Where your evaluation needs other endpoints, we can evaluate and make recommendations for the best fit with your biological evaluation plan.

Validation and verification study panel selection will start based on your device’s materials, contact type, duration and reasonably foreseeable misuse, as ISO 10993 expects. We help clients document which tests are needed and which are not, avoiding unnecessary studies, time and cost.

Find out more: ISO 10993-1:2025: The End of Box-Ticking Biocompatibility Assessments

Class II and III medical devices need ongoing evidence that manufacturing remains under control. We offer scheduled bioburden and biocompatibility testing maintenance programmes with agreed turnaround times and trended results, so shifts in process or materials performance are identified early.