Biocompatibility Evaluation of Medical Devices
Biocompatibility evaluation is a fundamental process in the development and certification of medical devices. It involves assessing the biological response generated by the device’s contact with cells, tissues, or body fluids, with the aim of preventing adverse effects and ensuring patient safety.
The topic was addressed by Matteo Calassanzio, Head of the Microbiology Department at Renolab, in an article published in T-Magazine, the magazine of the Tentamus Italia Group.
To browse the full issue of T-Magazine: CLICK HERE
The regulatory reference is the ISO 10993 series, which frames biological testing within a structured risk management process.
ISO 10993-1: BEP and BER
ISO 10993-1 introduces two key documents in the evaluation process:
- Biocompatibility Evaluation Plan (BEP): defines the evaluation strategy, the identification of biological risks, and the selection of endpoints (e.g., cytotoxicity, sensitization, irritation).
- Biocompatibility Evaluation Report (BER): provides a critical interpretation of the collected data and supports conclusions regarding the biological safety of the device.
This approach enables the integration of biological evaluation into the overall risk management system required by regulation.
ISO 10993-5: Cytotoxicity Testing at Renolab Laboratories
Cytotoxicity assesses a material’s ability to compromise cell viability or structural integrity. At Renolab laboratories, tests are conducted using L929 cell lines. Cells are placed in direct contact with the device, and viability is measured through MTT or XTT colorimetric assays. Only viable cells reduce the reagents, producing a chromatic signal measured by spectrophotometer at 570/450 nm. A negative result indicates that the material does not release potentially harmful extractable substances.
ISO 10993-23: Irritation Assessment Using In Vitro Models
Biocompatibility cannot rely solely on cytotoxicity testing. ISO 10993-23 governs the evaluation of skin irritation, defined as an acute and reversible inflammatory reaction. Renolab performs tests in compliance with the standard, using in vitro methods, including three-dimensional reconstructed human epidermis (RhE) models, in line with the principles of reducing animal testing. Even minimal variations can alter the biological interaction with the body. Through the rigorous application of ISO 10993 standards, a scientifically robust biological evaluation process compliant with regulatory requirements is ensured.
ISO/IEC 17025:2018 Accredited Testing
Renolab is accredited according to ISO/IEC 17025:2018 for two tests within the biological evaluation of medical devices:
- In vitro cytotoxicity determination – XTT test (ISO 10993-5).
- In vitro skin irritation determination (ISO 10993-23).
Accreditation strengthens the reliability of analytical results and enables the provision of qualified support to manufacturers throughout their medical device regulatory compliance pathways.
Additionally, with the support of ISEMED, a consulting company of the Tentamus Italia Group, regulatory consultancy services for medical devices can be provided, integrating accredited testing activities and regulatory support within a structured pathway.