What is IEC 62366-1?

What is IEC 62366-1?

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE.

Is tc108 the same as IEC 62368-1?

It is worth noting that TC108 is also responsible for IEC 60950-1 and IEC 60065, and has implemented changes in the latest editions of both to ease the transition to the new standard. Following publication of the first edition of IEC 62368-1, in 2010, the North American Bi-National CSA/UL 62368-1 Ed. 1 was adopted in February 2012.

What is the difference between selv 60950-1 and IEC 62368?

One example is that a 60950-1 certified switched-mode power supply typically has output circuits classified as safety extra-low voltage (SELV), whereas IEC 62368-1 refers to ES1 energy sources, which considers both voltage and current. As a result, SELV is no longer defined.

When did en 62368-1 stop being required?

In the OJ, the date of cessation of this presumption was June 20, 2019, which historically had been the same as the Date of Withdrawal of the outgoing standards. In Europe, separating the DoW and the date of cessation of conformity introduced confusion about the status of EN 62368-1.