What is the difference between IEC 62366 2015 and 2020 ?

IEC 62366 is an essential standard for medical device developers, providing guidance on the application of usability engineering to medical devices. The standard defines the scope and purpose of the testing procedures for probe devices used to verify the protection against electric shock in electrical equipment and related areas.

IEC 62366-2015 and IEC 62366-2020 are two of the most recent versions of this standard. Both versions have similar goals, but there are some key differences between them. In this article, we will explore the key components of IEC 62366-2015 and its latest version, IEC 62366-2020, and their respective purposes in ensuring safety and effectiveness of medical devices.

IEC 62366-2015 is a widely recognized international standard that provides a standardized methodology for conducting safety tests to assess the potential risks of electrical contact. The standard defines the requirements and guidelines for probe devices used to verify the protection against electric shock in electrical equipment and related areas. It outlines the testing procedures for electrical equipment, including the use of different types of probe devices, the testing environment, and the testing methods.

The primary purpose of IEC 62366-2015 is to ensure the safety of electrical equipment, prevent injuries, and promote compliance with safety regulations. By adhering to this standard, manufacturers can identify and rectify potential hazards during product development stages, thereby safeguarding end-users from electric shock injuries.

IEC 62366-2020 is the latest version of the IEC 62366 standard, which builds upon the foundation of IEC 62366-201It continues to provide a standardized methodology for conducting safety tests to assess the potential risks of electrical contact in electrical equipment and related areas. The primary purpose of IEC 62366-2020 is to provide updated guidance for manufacturers on the application of usability engineering to medical devices, including the use of probe devices for testing purposes.

In conclusion, IEC 62366 is an essential standard for medical device developers, providing guidance on the application of usability engineering to medical devices. IEC 62366-2015 and IEC 62366-2020 are two of the most recent versions of this standard, which continue to provide updated guidance for manufacturers on the safety and effectiveness of medical devices. By understanding the differences between these two versions, professionals can effectively design, test, and evaluate products for electrical safety.