This public website is intended to communicate directly with all parties and individuals interested in the work of ISO/TC 210. Our focus is on products with a medical purpose especially related to general aspects of quality and performance of those products. Our deliverables include standards, guidance documents, and white papers for quality management, risk management, usability (human factors), symbols and labeling, medical software, post market surveillance, small-bore connectors, and others. ISO/TC 210 pursues some projects in collaboration with other Technical Committees in IEC or ISO. For an overview of the current work program click here.

Through this website, we will inform you in a general way on the progress of our projects, on the intent to embark on new projects, and on other matters related to the work in ISO/TC 210. We do appreciate your feedback: please contact the committee manager of ISO/TC 210, Amanda Benedict. If you want more information, or wish to become involved in the work of ISO/TC 210, you can always contact your national standards organization (click here).

ISO/TC 210 is proud to have many stakeholder organizations as liaison partners, and we encourage them to contribute to the ongoing projects via the ISO process.  For a list of liaison partner committees and organizations click here. ISO/TC 210 is also proud to be collaborating with the International Medical Device Regulators Forum (IMDRF) on projects aimed at improving the use of standards for regulatory purposes to accelerate international medical device regulatory harmonization and convergence.  

Scott Colburn, chair ISO/TC 210