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Standards: Explosion and Challenges Maintaining/Updating
My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.
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!!!!
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.