Watch now: Things to Know About IEC 60601-1 Amendment 2
We will share details of the changes, possible areas of concern and which collaterals have undergone major changes. We will also share key points to consider when using 62368-1 devices in your design, such as a means of patient protection.
Webinar date: July 14, 2022
Speaker: Pamela Gwynn, principal engineer
The IEC published amendment 2 to IEC 60601-1, the standards for the basic safety and essential performance of medical electrical equipment, in August 2020. With updates to the base standard published, the amendments to the collateral standards quickly followed.
While many of the updates to the base standard consist of corrections or clarifications to existing requirements, some of the updates require effort on the part of manufacturers to upgrade from the previous version. This includes updates to:
Risk management standard ISO 14971:2019
Usability standard IEC 62366-1:2015 + AMD 1:2020
Software standard IEC 62304:2006 + AMD1: 2015
Clause 8 updates allow IEC 62368-1:2018 compliant devices to provide means of operator protection.