IEC 62366 Insights

What is IEC 62366?

IEC 62366 (now superseded by IEC 62366-1:2015 and IEC 62366-2:2020) addresses the application of usability engineering to medical devices. It specifies a process for medical device manufacturers to analyze, specify, design, verify, and validate the usability of their products. The goal is to reduce use errors and associated risks, thereby enhancing patient safety. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements related to usability and human factors engineering.

Find organizations using IEC 62366 on Sumble →

What other technologies are related to IEC 62366?

IEC 62366 Complementary Technologies

IEC 62304

IEC 62304 is the standard for medical device software lifecycle processes. It complements IEC 62366 by addressing software usability aspects.

mentioned alongside IEC 62366 in 15% (341) of relevant job posts

ISO 14971

ISO 14971 specifies requirements for risk management applied to medical devices. Usability engineering (covered by IEC 62366) is a key aspect of risk management.

mentioned alongside IEC 62366 in 10% (336) of relevant job posts

IEC 60601

IEC 60601 is a series of standards for the basic safety and essential performance of medical electrical equipment. IEC 62366 provides essential guidance for fulfilling usability requirements which contribute to basic safety.

mentioned alongside IEC 62366 in 12% (107) of relevant job posts