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A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. One blog post is an article from InCompliance
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.
Leo Eisner, the “IEC 60601 Guy”, will be presenting a session at MD&M West on Wednesday, Feb. 6, 2019 from 3:15 – 5:30PM Topic: Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances Track: MD&M West: Regulatory & Quality
Standards are a key priority for the International Medical Device Regulators Forum (IMDRF). Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential
On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards & FDA’s Release