Biocompatibility Evaluations for Medical Devices
The International Organization for Standardization (ISO) has announced the upcoming release of the revised ISO 10993-1: Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process in 2025. This highly anticipated update will bring significant changes to the framework for assessing biocompatibility, ensuring that medical devices meet stringent safety and performance standards worldwide.
Key Changes to ISO 10993-1:2025
The planned revision introduces several enhancements aimed at modernizing and improving biocompatibility evaluations. The key changes to the standard are outlined in the table from the NSAI announcement:
Section
Risk Management
Chemical Characterization
Use of Alternatives to Animal Testing
Toxicological Assessment
Device-Specific Guidance
Biological Endpoint Testing
Key Updates
Integration of biological evaluation more deeply within the risk management process, focusing on continuous assessment throughout the product lifecycle.
Enhanced guidance on material characterization and identification of potential risks associated with device components
Expanded support for in vitro and in silico testing methods to reduce reliance on animal studies.
Detailed requirements for evaluating toxicological risks, including cumulative exposure and systemic effects.
Introduction of clearer recommendations tailored to specific device types and their intended use.
Updated criteria for determining when specific tests are required, ensuring a targeted and effective evaluation process.
Section | Key Updates
Risk Management
Integration of biological evaluation more deeply within the risk management process, focusing on
continuous assessment throughout the product lifecycle.
Chemical Characterization
Enhanced guidance on material characterization and identification of potential risks associated with device components.
Particulate Matter Testing
Revised criteria for measuring particulate matter released into breathing gas pathways, with stricter thresholds.
Chemical Characterization
Inclusion of additional guidance on assessing chemical leachables and extractables specific to breathing gas pathways.
Use of Alternatives to Animal Testing
Expanded support for in vitro and in silico testing methods to reduce reliance on animal studies.
Toxicological Assessments
Detailed requirements for evaluating toxicological risks, including cumulative exposure and systemic effects.
Device-Specific Guidance
Introduction of clearer recommendations tailored to specific device types and their intended use.
Biological Endpoint Testing
Updated criteria for determining when specific tests are required, ensuring a targeted and effective
evaluation process.
Why This Matters
The revisions to ISO 10993-1 reflect the evolving landscape of medical device development and regulation. These updates aim to:
• Ensure Comprehensive Safety:
By embedding biological evaluation within risk management processes, manufacturers can address safety concerns proactively.
• Promote Ethical Practices:
Increased emphasis on non-animal testing methods aligns with global trends toward more ethical and sustainable
practices.
• Streamline Regulatory Compliance:
Clearer guidance on testing and documentation requirements will help manufacturers demonstrate conformity with regulatory frameworks such as EU MDR/IVDR and FDA requirements.
• Ensure Comprehensive Safety:
• Promote Ethical Practices:
• Streamline Regulatory Compliance:
By embedding biological evaluation within risk management processes, manufacturers can address safety concerns proactively.
Increased emphasis on non-animal testing methods aligns with global trends toward more ethical and sustainable practices.
Clearer guidance on testing and documentation requirements will help manufacturers demonstrate conformity with
regulatory frameworks such as EU MDR/IVDR and FDA requirements.
Implications for Manufacturers following Biocompatibility Evaluations for Medical Devices
Regulatory bodies like the FDA and the European Commission heavily rely on ISO 10993-1 as a cornerstone for evaluating medical device safety. With the upcoming changes, manufacturers should:
• Assess Current Practices:
Review existing biocompatibility evaluation processes and identify gaps relative to the revised standard.
• Plan for Implementation:
Allocate resources to update testing protocols, technical documentation, and risk management systems.
• Stay Informed:
Engage with updates from ISO, regulatory authorities, and industry bodies to ensure preparedness.
• Assess Current Practices:
• Plan for Implementation:
• Stay Informed:
Review existing biocompatibility evaluation processes and identify gaps relative to the revised standard.
Allocate resources to update testing protocols, technical documentation, and risk management systems.
Engage with updates from ISO, regulatory authorities, and industry bodies to ensure preparedness.
Support from CLIN-r+
Biocompatibility Evaluations for Medical Devices implies that navigating these changes can be complex, but CLIN-r+ is here to help. Our team specializes in:
- Conducting gap assessments to align current practices with revised standards.
- Developing robust risk management frameworks that integrate biocompatibility evaluations.
- Offering training and expertise on alternative testing methods and updated requirements.
For more information and support on how to adapt to the revised ISO 10993-1 standard,
contact us today or schedule a consultation:
