Biocompatibility Testing for Medical Devices: Ensuring Safety and Compliance

Biological evaluation is done to measure the biological compatibility of medical devices with biological systems. Biocompatibility testing ISO 10993 plays a crucial role in assessing the safety of medical devices. Evaluation is performed using a sequence of tests mentioned in many international and national standards and guidelines concerning biological evaluation of medical devices.

The ISO 10993 biological evaluation of medical devices framework guides the testing process, ensuring compliance with regulatory requirements. 10993 biocompatibility testing is performed based on the medical device classification, considering its nature, duration of anticipated contact with human tissue, and relevant biological endpoints.

The biological evaluation of medical devices intended for human use must be a structured part of the risk management process as per ISO 14971. A well-planned and documented ISO biocompatibility evaluation ensures the device’s safety and effectiveness, requiring oversight by experienced professionals.

Importance of Biological Evaluation in Medical Devices

The rigor necessary in biological evaluation is mainly determined by the use, degree, frequency, and duration of exposure, as well as the hazards identified for the medical device or material. Testing is usually not necessary when sufficient information is already available with the medical device manufacturer to perform a risk assessment of the material and/or the medical device. However, a biological evaluation report is essential for documenting the findings and ensuring compliance with regulatory requirements, including FDA biocompatibility guidelines.

The biocompatibility testing for medical devices plays a crucial role in assessing potential biological risks and ensuring patient safety. Manufacturers should develop a biological evaluation plan template to systematically evaluate biological safety over the entire life-cycle of a medical device. The risk management documentation should also specify the biological hazards associated with the medical devices. Evaluation can include both a review of relevant existing preclinical and clinical data and actual testing data held by the medical device manufacturer.

Critical Considerations for Biological Evaluation

Following shall be the considered during biological evaluation:

• Material of construction in medical devices
• intended additives, process contaminants and residues
• packaging materials that directly or indirectly contact the medical device can transfer chemicals to the medical device and then indirectly to the patient or clinician
• leachable substances
• degradation products
• other components and their interaction in final products
• performance and characteristic of the medical device

Biological Evaluation Plan

A biological evaluation plan is developed to ensure that all risks are addressed. As per ISO 10993-1:2018, the biocompatibility testing for medical devices and the biological evaluation of any material or medical device intended for human use must be part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.

The biological evaluation plan is developed prior to testing, helping to minimize unnecessary testing, maintain compliance with all pertinent standards and regulations, and provide evidence for the ultimate goal of ensuring product safety. Proper planning ensures that biocompatibility testing is conducted efficiently and in alignment with regulatory expectations.

According to Section B.2.2 of ISO 10993-1:2018, the biological evaluation plan should be prepared by a knowledgeable and experienced team and should include, at a minimum:

• Arrangements for gathering applicable information from published literature (including information sources and search strategies), in-house and supplier data, and other sources to conduct risk analysis.
• Arrangements for conducting the evaluation, including the need for specific technical competencies relevant to the medical device application.
• Arrangements for reviewing and approving the plan as part of the overall design control process.
• Arrangements for reviewing the final conclusions of the evaluation and approving any additional biocompatibility testing for medical devices if needed.
• Arrangements for the final review and approval of the outcomes of the iso 10993 biocompatibility risk assessment, including risk control measures, documentation of residual risks, and disclosure of residual risks through product labeling.

A well-structured biological evaluation plan ensures that biocompatibility testing is performed systematically, supporting compliance and patient safety.

Biological Evaluation Report

A biological evaluation report (BER) is a collective summary of biological test performed and justifications for not performed test used to demonstrate how compatible a medical device is with the human body. In other words, the BER provides evidence of a medical device’s biological safety, known as biocompatibility.

Biological evaluation report also includes;

• short description of the material or medical device including its intended use,
• the analysis of all selected literatures and data, both favorable and unfavorable,
• a critical evaluation of the hazards, associated risks and appropriate safety measures;
• a description of the methods of weighting the different papers; particular attention should be given to circumstances where there are repeated publications by the same authors, in order to avoid overweighting multiple publications of the same tests;
• a list of publications appropriately cross-referenced in the evaluation;
• Gap analysis for already available information for biological safety, rationale for why additional information isn’t needed and a statement confirming the biological risk analysis and risk controls that have been completed.

A systemic approach to a biological evaluation of medical devices as part of a risk management process