A biological assessment plan has been developed to systematically assess whether a device intended for use in humans poses an unacceptable biological safety risk.
Food and Drug Administration (FDA) Guidance Document, Application of the international standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within the risk management process” (2020), sets out information on general principles of biological evaluation of medical devices within a risk management framework.1 Areas to be considered in a biological assessment plan include the intended use of the equipment, its construction materials and manufacturing process, available biological safety data and knowledge gaps that should be addressed through testing.
Tests used to support the biological evaluation process may include chemical characterization and toxic risk assessment, cytotoxicity, irritation, sensitization, hemocompatibility, pyrogenicity, genotoxicity, and systemic toxicity.
A robust biological evaluation plan is not only important from a safety point of view, but can also help improve efficiency in equipment testing and development. Jordi Labs is an expert in biological evaluation and biocompatibility testing of medical devices and can help you understand which tests are necessary as part of a biological evaluation plan, so you don’t waste any time on unnecessary testing .
planning a biological assessment
A biological assessment plan should be made with the support of ‘knowledgeable and experienced professionals’ established in ISO 10993-1.1 This is why engaging a partner like Jordi Labs can help accelerate and improve your biological assessment processes. The first part of creating a biological assessment plan is to consider what biological assessment information is available and what is missing for any of the materials used in the context of the finished equipment.
It is acceptable to use existing data on biological risks in biological assessment if previous biological assessment and testing has been performed under sufficiently stringent conditions and is representative of the finished device configuration. This is one way a thorough review before starting any biological evaluation can help avoid any unnecessary testing. It is also important to consider, especially for new materials that have no prior use in medical devices, whether the properties of the isolated material and the medical device may be different.
A biological assessment should evaluate the risk to all relevant biological safety endpoints as determined by ISO 10993-1:2018 for a specific device category. This includes considering the duration and type of contact with the body.
Systemic endpoints, such as genotoxicity, carcinogenicity, and acute or chronic systemic toxicity, can be addressed through biological test data or chemical characterization and toxic risk assessment data. On the other hand, localized endpoints, such as cytotoxicity, irritation and hemocompatibility, usually require biological test data.
Jordi Labs can help you assess what steps you need to include in your biological assessment process and how to stay compliant with any biological assessment laws and regulations. Jordi Labs has 40 years of experience in chemical testing, so for new materials that require extensive testing and characterization, the company can bring that expertise to your biological evaluation process.
- ISO 10993-1:2018, https://www.iso.org/standard/68936.htmlAccessed April 2022
- FDA Guidance Application of the international standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within the risk management process” (2020)