IEC 62304 Ed. 2: Software Life Cycle Standard for Health Software.

Abstract

The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software development processes through the use of the IEC 62304 standard. The goal of this standard revision project was to extend the scope of the standard to all health software and also to bring the requirements of the 12 year old standard back to the state-of-the-art including provisions for cybersecurity. The joint IEC/SC62A and ISO/TC215 project team revised the standard and adapted its risk management, usability, and security requirements to serve both the medical device industry and the overall health software industry. The resulting second version of the standard has gone through a multistage global voting process to achieve a consensus of the requirements to serve both these communities. The resulting standard has potential to have a major impact on the quality of software used in health care globally.