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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.
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.
Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.