Skip to main content


ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

APS Staff participated in the annual gathering of Technical Committee 194 of the International Standards Organization which is responsible for the continuing development and revisions of the guidelines for “Biological and Clinical Evaluation of Medical Devices”. The output of this committee and the associated 17 working groups is critical in the global processes standardizing biological test methods for the evaluation of medical and dental materials and devices. The committee and the working groups enjoy active participation by a global group of technical matter experts from industry, commercial testing laboratories, regulatory bodies and academic institutions. Their combined goal it is to come to consensus, occasionally after enthusiastic discussions, and generate guidance documents and standard methods for this critical phase of medical device and materials testing prior to release for commercial use.

The output from the working groups guides global activity in the areas of biocompatibility, hemocompatibility, genotoxicity, systemic toxicity, irritation, sensitization and overall tissue response to materials.

APS staff, including Kent Grove, Michael Conforti and Mark Smith, were invited to participate in this 5 day session held in Lund Sweden in early June. Our participation as new members to the organization was welcomed. We all learned a great deal about the process whereby these guidance documents are created, reviewed, discussed and finally submitted to the ISO headquarters for final approval and distribution to global users. We returned with fresh insight from subject-matter experts and representatives of US regulatory bodies into many of the ISO 10993 standards including device implantation and hemocompatibility tests. We also networked with companies developing exciting new procedures for sensitization and irritation assays.

lund       medicon

Over the next year, APS will participate with several global partners evaluating new in-vitro substitutes for classical biological assays which have the potential to reduce both assay cost and animal utilization. These “round-robin” assessments allow the new methods to be tested by many expert groups in laboratories across the globe to confirm that the methods are reproducible and accurate. Publication of results from these global partnerships can significantly enhance the rate of change in the global standards to being these novel methodologies into the forefront of the ISO guidelines and dramatically change the nature of biocompatibility testing in the global community.

Watch this space for progress on this front by Scientists at APS. For more information on methods under development, please contact Kent Grove at 763-951-8096.