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SeqMatic Forum: Histopathology Use Case Within ISO Guidelines

Throughout the research and development (R&D) phase, histopathology readouts serve as a pivotal tool in screening materials to discern those that are compatible with tissue from those that are not, effectively bridging the gap between early experimentation and clinical readiness. From tissue damage and regeneration to the foreign body response, including inflammation, each reaction must be meticulously evaluated. As these medical devices transition from the bench to bedside, adherence to ISO guidelines becomes paramount, ensuring a standardized approach to evaluating potential risks and ensuring biocompatibility. These guidelines, such as ISO 10993-3 for carcinogenic and developmental toxicity, ISO 10993-6 for local effects, ISO 10993-10 for skin irritation and sensitization, and ISO 10993-11 for systemic effects, provide a comprehensive framework for assessing the safety of medical devices (Figure 1). This meticulous evaluation process is particularly crucial for materials that may extract or leach out of implantable devices, posing potential risks to patients.

Figure 1: Table A.1 of the ISO 10993-1 document presents a comprehensive table designed to guide manufacturers in selecting the appropriate biological evaluation tests for their medical devices1. This table is crucial for determining the necessary assessments based on the nature and duration of contact between the medical device and the body. It categorizes devices according to the type of body contact (e.g., skin, blood, or tissue) and the duration of exposure (limited, prolonged, or permanent), recommending specific tests for cytotoxicity, sensitization, irritation, or systemic toxicity, among others. This structured approach helps ensure that all potential biological risks are thoroughly evaluated, facilitating the development of safer medical devices by providing a clear roadmap for compliance with regulatory standards and protecting patient health.

Citations:

  1. International Organization for Standardization. (Year). ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. https://www.iso.org/standard/68936.html

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