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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.
2 February 2022 On 1 February 2022 the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark
The international standard for the application of medical device symbols on labels, ISO 15223-1, has been amended and the 4th Edition will replace ISO 15223-1:2016
This amendment is multifaceted and will introduce many new changes to the symbol requirements that medical device organizations around the world will be expected to follow.
The 4th Edition of ISO 15223-1 will include 25 additional symbols in total, newly defined terms and removal of existing terms as well as inclusion of terms from other standards, and expansion of the informative annex containing examples—just to name a few.