Standards are everywhere: they impact pretty much every aspect of modern life. They provide for communication, interoperability, and safety and, on a larger scale, support international trade for the benefit of all people. From wall plugs to TV broadcast, to internet communication, to car navigation and airplane operation: standards impact their safe and proper functioning. This is not different for medical devices: standards govern their operation and communication with other devices. In addition, standards provide for a framework of safety requirements and test protocols so that medical devices are safe when used according to the instructions.
DITTA strongly supports international standards established by all stakeholders, such as from ISO and IEC. Such standards combine the competence of the best available experts on a global scale, whether the standard is about safety requirements for electrical equipment used in medical practice, about measuring the radiation exposure in radiotherapy, about sharing diagnostic images across multiple competence centers, about testing of user interfaces, about graphical symbols on medical equipment, or about consistent types of alarms for equipment used in intensive care situations.
In particular when established by a multi-stakeholder expert group, standards are often also used for regulatory purposes: they are helpful in demonstrating that products comply with national regulatory requirements. It is this additional use of standards that is being referenced in the rules of the World Trade Organization WTO when those request that technical (product) regulation should be based on international standards (see Article 2 in link). That role of standards in national product approval schemes is key in improving international trade. In the case of medical technology, free international trade is beneficial for and in the interest of all citizens of the world as it enhances access to healthcare and helps contain healthcare technology cost.
DITTA is a category A liaison organization to ISO/TC 210 (“Quality management and corresponding general aspects for medical devices”). Many experts of its members contribute actively to the development of standards for safety and performance in this and in other technical committees. DITTA is also closely involved in dialogues with organizations of regulators as well as with standards development organizations to improve standards development processes.