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The upcoming revision of ISO 10993-1and its consequences

In the dynamic world of the pharma and biotech industries using medical devices for drug administration, adopting a risk-based approach is no longer just an option—it’s a critical necessity for ensuring patient safety and regulatory compliance. But have you considered how implementing this approach, as outlined in ISO 14971:2019, could revolutionize your contamination control processes? Emphasizing risk management not only deepens your understanding of potential hazards, but also enhances the standardization of biocompatibility in medical devices, aligning with ISO 10993-1:2018. This isn’t just about ticking boxes for compliance—it’s about safeguarding patient health and optimizing your product’s lifecycle. 🚀

🔄 The Upcoming Changes in ISO/DIS 10993-1

The medical device industry is on the brink of a significant transformation with the forthcoming ISO/DIS 10993-1revision. Based on the current draft (June 2024), these updates introduce several crucial elements:

  • Life Cycle Considerations: The 2024 draft emphasizes the need to evaluate biocompatibility throughout the entire lifecycle of a medical device, ensuring safety from initial development through post-market surveillance. This is particularly vital for reprocessable devices, where biocompatibility must be reassessed after each use and reprocessing cycle to maintain ongoing safety.
  • Biological Equivalence: New, detailed criteria for assessing the biological equivalence of medical devices are introduced. This update aims to streamline the regulatory approval process, reducing the need for redundant testing and accelerating time-to-market.
  • Risk Categorization: The draft provides refined guidance on defining the need for biological testing based on risk. A more structured approach to categorizing devices by body contact and exposure duration supports precise decision-making, focusing resources where they are most needed.
  • Alignment with Risk Management (ISO 14971): The draft further integrates ISO 14971 principles into the biological evaluation process, ensuring that biological risks are considered within the overall risk management framework, leading to a more cohesive approach to device safety.
  • Detailed Annexes and Expanded Guidance: Updated and expanded annexes offer more detailed guidance on biological evaluation, including considerations for emerging materials like nanomaterials, degradation products, and specific testing strategies.

🧪 Enhancing Biocompatibility Through Chemical Characterization

Chemical characterization, particularly through extractables and leachables (E&L) studies, is becoming central to biocompatibility assessments. As emphasized in ISO 10993-18, detailed chemical analysis is crucial for identifying potential risks associated with material composition, often reducing the need for in vitro and in vivo testing. At Avisulting, our cross-industry expertise in E&L risk management enables us to guide you effectively through this process, ensuring your products meet both compliance standards and the highest safety levels.

🛡️ The Critical Role of Toxicological Risk Assessment

ISO 10993-17 is vital in supporting biological risk assessment by providing clear guidelines for toxicological risk evaluation. This process helps determine the necessity for additional biological testing, relying on risk categorization defined in ISO 10993-1. Integrating chemical characterization with toxicological assessments is key to defining the biocompatibility of materials and ensuring patient safety.

🔧 Biocompatibility: A Step Towards Standardization and Lifecycle Management

By applying a risk-based approach according to ISO 14971:2019, you can better manage contamination risks and harmonize your biocompatibility assessments through precise chemical characterization of components, in line with ISO 10993-18:2020. The emphasis on lifecycle management in ISO 10993-1 highlights the importance of ongoing biocompatibility evaluation, ensuring safety and compliance from development to post-market. With the upcoming updates to ISO 10993-1 and the continued focus on minimizing animal testing, it’s critical to adapt your processes to meet these evolving standards. At Avisulting, we bring deep industry expertise to help you navigate these changes and optimize your risk management strategies.

💬 Navigating the Future: Let’s Discuss Your Challenges

As the standards evolve, so too must your processes. What specific challenges are you facing in implementing these updates? How are you planning to adapt your procedures to meet the increasing demands of biocompatibility evaluations? At Avisulting, we’re here to help you navigate this complex landscape and ensure your products meet the highest standards of safety and compliance. Contact us today for a free consultation, and let’s explore how we can transform these challenges into opportunities for your business.

For more information and to explore our services, visit Avisulting.

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