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This is a follow-up to IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! and IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023. 3 Weeks after the initial Nomination of experts
We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development.
This is a follow-up to the original post of IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 November
This post talks about the Call for Experts and nomination of convenors and the short time periods. Get moving if you are interested.
During the IEC TC62 / SC62A meetings in Seoul, South Korea, 18 – 22 Sept 2023 there was general consensus between the National Committees (NCs) to move forward with the IEC 60601-1 4th edition project. Yeah, finally after so many years!!!!
27 November 2023 The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts
Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.