IEC 60601 Amendments – Eisner Safety Consultants

FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we

IEC 60601 Amendments Updates Have Published: Changes and Impacts

In the November issue of InCompliance Magazine I discuss the IEC 60601 Amendments Project, which includes the IEC 60601-1 General standard and the Collateral standards (IEC 60601-1-XX standards but for IEC 60601-1-3), and some of the changes to the General and Collateral