Comprehensive Sum-Up: Recent Updates to the ISO 10993 Series Shaping the Future of Biocompatibility

The landscape of medical device biocompatibility testing is undergoing significant transformations with recent updates to the ISO 10993 series. These revisions aim to enhance the safety and efficacy of medical devices by refining evaluation protocols. This article delves into the latest developments, focusing on the draft releases of ISO 10993-6, ISO 10993-4, ISO 10993-17, and ISO 10993-12, among others.

ISO 10993-6 Draft (Under development)

ISO 10993-6 addresses the assessment of local effects after the implantation of medical devices. The latest draft introduces several key updates:

  • Enhanced Test Methods: The draft specifies improved methodologies for evaluating local tissue responses, ensuring more accurate assessments of biocompatibility.
  • Expanded Material Scope: It now encompasses a broader range of materials, including degradable and absorbable substances, reflecting the diversity of modern medical devices.
  • Refined Evaluation Criteria: The criteria for assessing tissue reactions have been updated to provide clearer guidance on interpreting results.

These changes are pivotal for manufacturers, as they necessitate adjustments in testing protocols to align with the new standards, thereby ensuring the safety and performance of implantable devices.

Source: https://www.iso.org/standard/83976.html 

ISO 10993-4 Draft

ISO 10993-4 focuses on the selection of tests for interactions with blood. The latest draft update introduces significant revisions:

  • Revised Device Classification: The classification system for devices intended for blood contact has been updated, facilitating a more precise selection of appropriate tests.
  • Updated Testing Guidelines: The draft provides enhanced guidance on evaluating thrombosis, hemolysis, and other blood-related interactions, ensuring comprehensive assessments.
  • Integration of New Technologies: It incorporates considerations for emerging technologies and materials, promoting innovation while maintaining safety standards.

These updates are crucial for manufacturers to ensure that devices interacting with blood meet stringent safety criteria, thereby minimizing potential adverse effects.

Source: https://www.iso.org/standard/86862.html

ISO 10993-17 Draft (Under development)

ISO 10993-17 pertains to the establishment of allowable limits for leachable substances. The latest draft update includes:

  • Refined Risk Assessment Procedures: The draft outlines more detailed procedures for assessing the risks associated with evaluated compounds, enhancing the accuracy of safety evaluations.
  • Updated Toxicological Data Requirements: It specifies new requirements for toxicological data, ensuring that evaluations are based on the latest scientific evidence.
  • Alignment with EU Regulation 2017/745: The draft emphasizes harmonization with the EU Medical Device Regulation (MDR), establishing clearer links to regulatory requirements for leachables in medical devices.

These revisions are vital for manufacturers to accurately assess and control the release of potentially harmful substances from medical devices, thereby safeguarding patient health.

Source: https://www.iso.org/standard/88201.html 

ISO 10993-12 Draft (Under development)

ISO 10993-12 specifies requirements and provides guidance on the preparation of samples and the selection of reference materials for medical device testing. The latest draft update introduces several important changes:

  • Clarified Sample Preparation Procedures: The draft offers more detailed instructions on preparing samples, ensuring consistency and reliability in biocompatibility testing.
  • Updated Reference Material Selection: It provides enhanced criteria for selecting appropriate reference materials, facilitating more accurate comparisons in test results.
  • Integration with Other Standards: The draft emphasizes alignment with related standards, such as ISO 10993-18, to ensure a cohesive approach to material characterization and biological evaluation.

These updates are essential for manufacturers to standardize testing procedures and improve the reproducibility of biocompatibility assessments.

Source: https://www.iso.org/standard/88205.html

Other Notable Updates

In addition to the aforementioned drafts, other parts of the ISO 10993 series are undergoing revisions:

  • ISO 10993-1 Draft Revision: This part introduces a brand new definition of cumulative contact, which considers the total exposure time of the device material with the body, regardless of the number of separate contact episodes. Additionally, the revision takes a fresh approach to the medical device lifecycle, emphasizing the need for evaluation throughout the device’s entire lifespan, including the design, manufacturing, and post-market stages. Another notable change is the removal of the “external communicating devices” category, which had previously been a separate classification. Instead, the revised standard integrates these devices into broader categories based on their intended use and body contact duration, simplifying the classification system.
  • ISO 10993-18 Draft: This part, dealing with chemical characterization of materials, is being revised to incorporate advanced analytical techniques and updated guidance on identifying and quantifying chemical constituents. These changes are essential for ensuring thorough material assessments.

Implications for Manufacturers

The ongoing revisions to the ISO 10993 series signify a shift towards more rigorous and comprehensive biocompatibility evaluations. Manufacturers must stay abreast of these changes to ensure compliance and maintain the safety and efficacy of their medical devices. Proactive adaptation to these updates will not only facilitate regulatory approval but also enhance patient safety and trust in medical technologies.

In conclusion, the recent and forthcoming updates to the ISO 10993 series represent a significant evolution in the standards governing medical device biocompatibility testing. Manufacturers are encouraged to thoroughly review these drafts and prepare for their implementation to uphold the highest standards of medical device safety and performance.

About the Author: Dr. Damian Matak

Dr. Damian Matak – an expert in medical device biocompatibility testing, serving as the CEO of ISO 17025-accredited and GLP-certified laboratories, including NABI – North American Biomedical Institute and EBI – European Biomedical Institute. As a member of the Polish Society of Toxicology and the I Local Ethical Committee, Dr. Matak contributes significantly to advancing safety standards in the biomedical field.

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